Contract manufacturerContract sterilizerArthrex, Inc. (Ave Maria, FL)FloridaGeneral and plastic surgeryAnesthesiologyCardiovascularDentalEar, nose and throatGastroenterology and urologyGeneral hospitalObstetrics and gynecologyOrthopedicRadiologyClinical chemistryHematologyClass IClass IIUnclassified
Arthrex, Inc.
Contract manufacturer and sterilizer ยท Ave Maria, FL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010331645 (openFDA record; or search FDA's registration database)
- FEI number
- 3010331645
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer; Contract sterilizer
- Owner or operator
- ARTHREX, INC. (FDA owner/operator no. 1220287)
- Registered address
- 6875 Arthrex Commerce Drive, Ave Maria, FL 34142
- Contract listings
- 371 device listings, 104 product codes, first listed Jan 27, 1994
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| BWN | Table And Attachments, Operating-Room | Class I | General and plastic surgery | Contract manufacturing | Jul 3, 2018 |
| BWN | Table And Attachments, Operating-Room | Class I | General and plastic surgery | Contract sterilization | Jul 3, 2018 |
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | Class I | Anesthesiology | Contract manufacturing | Jan 9, 2025 |
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | Class I | Anesthesiology | Contract sterilization | Jan 9, 2025 |
| CCX | Support, Patient Position | Class I | Anesthesiology | Contract manufacturing | Jun 12, 2023 |
| CCX | Support, Patient Position | Class I | Anesthesiology | Contract sterilization | Jun 12, 2023 |
| DXJ | Display, Cathode-Ray Tube, Medical | Class II | Cardiovascular | Contract manufacturing | Apr 3, 2024 |
| DXJ | Display, Cathode-Ray Tube, Medical | Class II | Cardiovascular | Contract sterilization | Apr 3, 2024 |
| EBW | Controller, Foot, Handpiece And Cord | Class I | Dental | Contract manufacturing | Sep 9, 2021 |
| EBW | Controller, Foot, Handpiece And Cord | Class I | Dental | Contract sterilization | Sep 9, 2021 |
| EQH | Source, Carrier, Fiberoptic Light | Class I | Ear, nose and throat | Contract manufacturing | Aug 29, 2024 |
| EQH | Source, Carrier, Fiberoptic Light | Class I | Ear, nose and throat | Contract sterilization | Aug 29, 2024 |
| FEI | Instrument, Special Lens, For Endoscope | Class I | Gastroenterology and urology | Contract manufacturing | Jan 25, 2017 |
| FEI | Instrument, Special Lens, For Endoscope | Class I | Gastroenterology and urology | Contract sterilization | Jan 25, 2017 |
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | Class I | Gastroenterology and urology | Contract manufacturing | Sep 10, 2021 |
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | Class I | Gastroenterology and urology | Contract sterilization | Sep 10, 2021 |
| FLE | Sterilizer, Steam | Class II | General hospital | Contract manufacturing | Oct 15, 2024 |
| FLE | Sterilizer, Steam | Class II | General hospital | Contract sterilization | Oct 15, 2024 |
| FMF | Syringe, Piston | Class II | General hospital | Contract manufacturing | Aug 23, 2007 |
| FMF | Syringe, Piston | Class II | General hospital | Contract sterilization | Aug 23, 2007 |
| FMP | Protector, Skin Pressure | Class I | General hospital | Contract manufacturing | Aug 30, 2021 |
| FMP | Protector, Skin Pressure | Class I | General hospital | Contract sterilization | Aug 30, 2021 |
| FRG | Wrap, Sterilization | Class II | General hospital | Contract manufacturing | Oct 15, 2024 |
| FRG | Wrap, Sterilization | Class II | General hospital | Contract sterilization | Oct 15, 2024 |
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Aug 7, 1996 |
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract sterilization | Aug 7, 1996 |
| FST | Light, Surgical, Fiberoptic | Class II | General and plastic surgery | Contract manufacturing | Sep 13, 2021 |
| FST | Light, Surgical, Fiberoptic | Class II | General and plastic surgery | Contract sterilization | Sep 13, 2021 |
| FTL | Mesh, Surgical, Polymeric | Class II | General and plastic surgery | Contract manufacturing | May 30, 2025 |
| FTL | Mesh, Surgical, Polymeric | Class II | General and plastic surgery | Contract sterilization | May 30, 2025 |
| FWB | Camera, Television, Surgical, Without Audio | Class I | General and plastic surgery | Contract manufacturing | Jul 25, 2024 |
| FWB | Camera, Television, Surgical, Without Audio | Class I | General and plastic surgery | Contract sterilization | Jul 25, 2024 |
| FWZ | Operating Room Accessories Table Tray | Class I | General and plastic surgery | Contract manufacturing | Aug 23, 2007 |
| FWZ | Operating Room Accessories Table Tray | Class I | General and plastic surgery | Contract sterilization | Aug 23, 2007 |
| FXR | Holder, Camera, Surgical | Class I | General and plastic surgery | Contract manufacturing | Nov 19, 2025 |
| FXR | Holder, Camera, Surgical | Class I | General and plastic surgery | Contract sterilization | Nov 19, 2025 |
| FZW | Expander, Surgical, Skin Graft | Class I | General and plastic surgery | Contract manufacturing | Feb 25, 2016 |
| FZW | Expander, Surgical, Skin Graft | Class I | General and plastic surgery | Contract sterilization | Feb 25, 2016 |
| GAB | Needle, Suturing, Disposable | Class I | General and plastic surgery | Contract manufacturing | Jan 27, 1994 |
| GAB | Needle, Suturing, Disposable | Class I | General and plastic surgery | Contract sterilization | Jan 27, 1994 |
| GAP | Suture, Nonabsorbable, Silk | Class II | General and plastic surgery | Contract manufacturing | Nov 26, 2008 |
| GAP | Suture, Nonabsorbable, Silk | Class II | General and plastic surgery | Contract sterilization | Nov 26, 2008 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | Class II | General and plastic surgery | Contract manufacturing | Nov 26, 2008 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | Class II | General and plastic surgery | Contract sterilization | Nov 26, 2008 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | Class II | General and plastic surgery | Contract manufacturing | Nov 28, 2007 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | Class II | General and plastic surgery | Contract sterilization | Nov 28, 2007 |
| GAZ | Tubing, Noninvasive | Class II | General hospital | Contract manufacturing | Dec 17, 2020 |
| GAZ | Tubing, Noninvasive | Class II | General hospital | Contract sterilization | Dec 17, 2020 |
| GBX | Catheter, Irrigation | Class I | General and plastic surgery | Contract manufacturing | Dec 5, 2023 |
| GBX | Catheter, Irrigation | Class I | General and plastic surgery | Contract sterilization | Dec 5, 2023 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Dec 28, 2012 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Dec 28, 2012 |
| GDZ | Handle, Scalpel | Class I | General and plastic surgery | Contract manufacturing | Sep 10, 2021 |
| GDZ | Handle, Scalpel | Class I | General and plastic surgery | Contract sterilization | Sep 10, 2021 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Aug 23, 2007 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Aug 23, 2007 |
| GEN | Forceps, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Sep 7, 2022 |
| GEN | Forceps, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Sep 7, 2022 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | Class I | General and plastic surgery | Contract manufacturing | Aug 23, 2007 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | Class I | General and plastic surgery | Contract sterilization | Aug 23, 2007 |
| GFF | Bur, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Aug 23, 2007 |
| GFF | Bur, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Aug 23, 2007 |
| HAB | Saw, Powered, And Accessories | Class I | General and plastic surgery | Contract manufacturing | Dec 27, 1994 |
| HAB | Saw, Powered, And Accessories | Class I | General and plastic surgery | Contract sterilization | Dec 27, 1994 |
| HIF | Insufflator, Laparoscopic | Class II | Obstetrics and gynecology | Contract manufacturing | Dec 23, 2013 |
| HIF | Insufflator, Laparoscopic | Class II | Obstetrics and gynecology | Contract sterilization | Dec 23, 2013 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Nov 26, 2008 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Nov 26, 2008 |
| HRX | Arthroscope | Class II | Orthopedic | Contract manufacturing | Jul 31, 2008 |
| HRX | Arthroscope | Class II | Orthopedic | Contract sterilization | Jul 31, 2008 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract manufacturing | Jul 28, 2017 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract sterilization | Jul 28, 2017 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Nov 26, 2008 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract sterilization | Nov 26, 2008 |
| HST | Apparatus, Traction, Non-Powered | Class I | Orthopedic | Contract manufacturing | Aug 23, 2007 |
| HST | Apparatus, Traction, Non-Powered | Class I | Orthopedic | Contract sterilization | Aug 23, 2007 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Oct 17, 2011 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | Oct 17, 2011 |
| HTC | Pliers, Surgical | Class I | General and plastic surgery | Contract manufacturing | Aug 29, 2024 |
| HTC | Pliers, Surgical | Class I | General and plastic surgery | Contract sterilization | Aug 29, 2024 |
| HTD | Forceps | Class I | General and plastic surgery | Contract manufacturing | Aug 7, 2003 |
| HTD | Forceps | Class I | General and plastic surgery | Contract sterilization | Aug 7, 2003 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Jul 13, 2001 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract sterilization | Jul 13, 2001 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Aug 23, 2007 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract sterilization | Aug 23, 2007 |
| HTO | Reamer | Class I | Orthopedic | Contract manufacturing | Jan 27, 1994 |
| HTO | Reamer | Class I | Orthopedic | Contract sterilization | Jan 27, 1994 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Aug 23, 2007 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract sterilization | Aug 23, 2007 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Aug 23, 2007 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract sterilization | Aug 23, 2007 |
| HTZ | Instrument, Cutting, Orthopedic | Class I | General and plastic surgery | Contract manufacturing | Aug 7, 1996 |
| HTZ | Instrument, Cutting, Orthopedic | Class I | General and plastic surgery | Contract sterilization | Aug 7, 1996 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Aug 23, 2007 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Aug 23, 2007 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Aug 7, 1996 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract sterilization | Aug 7, 1996 |
| HWQ | Passer | Class I | Orthopedic | Contract manufacturing | Aug 7, 2003 |
| HWQ | Passer | Class I | Orthopedic | Contract sterilization | Aug 7, 2003 |
| HWR | Driver, Prosthesis | Class I | Orthopedic | Contract manufacturing | Aug 29, 2024 |
| HWR | Driver, Prosthesis | Class I | Orthopedic | Contract sterilization | Aug 29, 2024 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Aug 21, 2014 |
| HWT | Template | Class I | Orthopedic | Contract sterilization | Aug 21, 2014 |
| HXB | Probe | Class I | Orthopedic | Contract manufacturing | Aug 7, 2003 |
| HXB | Probe | Class I | Orthopedic | Contract sterilization | Aug 7, 2003 |
| HXC | Wrench | Class I | Orthopedic | Contract manufacturing | Aug 29, 2024 |
| HXC | Wrench | Class I | Orthopedic | Contract sterilization | Aug 29, 2024 |
| HXD | Clamp | Class I | General and plastic surgery | Contract manufacturing | May 24, 2023 |
| HXD | Clamp | Class I | General and plastic surgery | Contract sterilization | May 24, 2023 |
| HXJ | Staple Driver | Class I | Orthopedic | Contract manufacturing | Nov 26, 2008 |
| HXJ | Staple Driver | Class I | Orthopedic | Contract sterilization | Nov 26, 2008 |
| HXL | Mallet | Class I | General and plastic surgery | Contract manufacturing | Aug 29, 2024 |
| HXL | Mallet | Class I | General and plastic surgery | Contract sterilization | Aug 29, 2024 |
| HXS | Twister, Wire | Class I | Orthopedic | Contract manufacturing | Aug 29, 2024 |
| HXS | Twister, Wire | Class I | Orthopedic | Contract sterilization | Aug 29, 2024 |
| HXW | Bender | Class I | Orthopedic | Contract manufacturing | Jan 9, 2025 |
| HXW | Bender | Class I | Orthopedic | Contract sterilization | Jan 9, 2025 |
| IZI | System, X-Ray, Angiographic | Class II | Radiology | Contract manufacturing | Jul 23, 2021 |
| IZI | System, X-Ray, Angiographic | Class II | Radiology | Contract sterilization | Jul 23, 2021 |
| JDQ | Cerclage, Fixation | Class II | Orthopedic | Contract manufacturing | Nov 15, 2017 |
| JDQ | Cerclage, Fixation | Class II | Orthopedic | Contract sterilization | Nov 15, 2017 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Aug 23, 2007 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Aug 23, 2007 |
| JDW | Pin, Fixation, Threaded | Class II | Orthopedic | Contract manufacturing | Oct 24, 2023 |
| JDW | Pin, Fixation, Threaded | Class II | Orthopedic | Contract sterilization | Oct 24, 2023 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class I | Clinical chemistry | Contract manufacturing | Jan 24, 2017 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class I | Clinical chemistry | Contract sterilization | Jan 24, 2017 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Oct 17, 2011 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract sterilization | Oct 17, 2011 |
| KGS | Retention Device, Suture | Class I | General and plastic surgery | Contract manufacturing | Nov 26, 2008 |
| KGS | Retention Device, Suture | Class I | General and plastic surgery | Contract sterilization | Nov 26, 2008 |
| KIK | Hook, Bone | Class I | General and plastic surgery | Contract manufacturing | Jan 9, 2025 |
| KIK | Hook, Bone | Class I | General and plastic surgery | Contract sterilization | Jan 9, 2025 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract manufacturing | Nov 19, 2021 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract sterilization | Nov 19, 2021 |
| KQM | Camera, Surgical And Accessories | Class I | General and plastic surgery | Contract manufacturing | Jan 25, 2017 |
| KQM | Camera, Surgical And Accessories | Class I | General and plastic surgery | Contract sterilization | Jan 25, 2017 |
| KQZ | Component, Traction, Non-Invasive | Class I | Orthopedic | Contract manufacturing | Aug 7, 1996 |
| KQZ | Component, Traction, Non-Invasive | Class I | Orthopedic | Contract sterilization | Aug 7, 1996 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Oct 17, 2011 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | Oct 17, 2011 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Oct 24, 2023 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract sterilization | Oct 24, 2023 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Class II | Orthopedic | Contract manufacturing | Jul 31, 2026 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Nov 26, 2008 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract sterilization | Nov 26, 2008 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | Contract manufacturing | May 18, 2018 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | Contract sterilization | May 18, 2018 |
| LMD | System, Digital Image Communications, Radiological | Class I | Radiology | Contract manufacturing | Jul 26, 2010 |
| LMD | System, Digital Image Communications, Radiological | Class I | Radiology | Contract sterilization | Jul 26, 2010 |
| LRY | Punch, Surgical | Class I | General and plastic surgery | Contract manufacturing | Aug 7, 2003 |
| LRY | Punch, Surgical | Class I | General and plastic surgery | Contract sterilization | Aug 7, 2003 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Aug 23, 2007 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract sterilization | Aug 23, 2007 |
| LXI | Guide, Drill, Ligament | Class I | General and plastic surgery | Contract manufacturing | Feb 27, 2018 |
| LXI | Guide, Drill, Ligament | Class I | General and plastic surgery | Contract sterilization | Feb 27, 2018 |
| LZB | Finger Cot | Class I | General hospital | Contract manufacturing | Dec 20, 2005 |
| LZB | Finger Cot | Class I | General hospital | Contract sterilization | Dec 20, 2005 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Aug 23, 2007 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Class II | Orthopedic | Contract sterilization | Aug 23, 2007 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Oct 5, 2018 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract sterilization | Oct 5, 2018 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Feb 24, 2016 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract sterilization | Feb 24, 2016 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Aug 23, 2007 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract sterilization | Aug 23, 2007 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | Class II | Orthopedic | Contract manufacturing | Dec 23, 2013 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | Class II | Orthopedic | Contract sterilization | Dec 23, 2013 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Aug 23, 2007 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract sterilization | Aug 23, 2007 |
| MHW | Dressing, Compression | Class I | General hospital | Contract manufacturing | Jan 8, 2014 |
| MHW | Dressing, Compression | Class I | General hospital | Contract sterilization | Jan 8, 2014 |
| MNU | Staple, Absorbable | Class II | Orthopedic | Contract manufacturing | Nov 26, 2008 |
| MNU | Staple, Absorbable | Class II | Orthopedic | Contract sterilization | Nov 26, 2008 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | Contract manufacturing | Nov 26, 2008 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | Contract sterilization | Nov 26, 2008 |
| MRW | System, Facet Screw Spinal Device | Unclassified | Orthopedic | Contract manufacturing | May 23, 2025 |
| MRW | System, Facet Screw Spinal Device | Unclassified | Orthopedic | Contract sterilization | May 23, 2025 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract manufacturing | Aug 23, 2007 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract sterilization | Aug 23, 2007 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract manufacturing | Feb 24, 2016 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract sterilization | Feb 24, 2016 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Class II | Hematology | Contract manufacturing | Jul 31, 2018 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Class II | Hematology | Contract sterilization | Jul 31, 2018 |
| OSV | Insufflator, Endoscopic Vessel Harvesting | Class II | Obstetrics and gynecology | Contract manufacturing | Sep 13, 2021 |
| OSV | Insufflator, Endoscopic Vessel Harvesting | Class II | Obstetrics and gynecology | Contract sterilization | Sep 13, 2021 |
| OUG | Medical Device Data System | Class I | General hospital | Contract manufacturing | Dec 13, 2017 |
| OUG | Medical Device Data System | Class I | General hospital | Contract sterilization | Dec 13, 2017 |
| OWN | Confocal Optical Imaging | Class II | Gastroenterology and urology | Contract manufacturing | Nov 19, 2025 |
| OWN | Confocal Optical Imaging | Class II | Gastroenterology and urology | Contract sterilization | Nov 19, 2025 |
| OWX | Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | Class II | General and plastic surgery | Contract manufacturing | May 30, 2025 |
| OWX | Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | Class II | General and plastic surgery | Contract sterilization | May 30, 2025 |
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | Class II | General and plastic surgery | Contract manufacturing | Nov 19, 2025 |
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | Class II | General and plastic surgery | Contract sterilization | Nov 19, 2025 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | Contract manufacturing | Jun 24, 2013 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | Contract sterilization | Jun 24, 2013 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Class II | Orthopedic | Contract manufacturing | Jul 26, 2019 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Class II | Orthopedic | Contract sterilization | Jul 26, 2019 |
| PLF | Bone Wedge | Class II | Orthopedic | Contract manufacturing | Dec 31, 2015 |
| PLF | Bone Wedge | Class II | Orthopedic | Contract sterilization | Dec 31, 2015 |
| PUI | Drape, Surgical, Exempt | Class II | General and plastic surgery | Contract manufacturing | Mar 28, 2024 |
| PUI | Drape, Surgical, Exempt | Class II | General and plastic surgery | Contract sterilization | Mar 28, 2024 |
| QHE | Shoulder Arthroplasty Implantation System | Class II | Orthopedic | Contract manufacturing | Mar 9, 2023 |
| QHE | Shoulder Arthroplasty Implantation System | Class II | Orthopedic | Contract sterilization | Mar 9, 2023 |
| QHQ | Total Shoulder Arthroplasty System | Class II | Orthopedic | Contract manufacturing | Jul 26, 2019 |
| QHQ | Total Shoulder Arthroplasty System | Class II | Orthopedic | Contract sterilization | Jul 26, 2019 |