Contract manufacturerInstrumed International Inc dba Avalign German Specialty Instruments (Schaumburg, IL)IllinoisAnesthesiologyCardiovascularDentalGeneral and plastic surgeryGastroenterology and urologyNeurologyObstetrics and gynecologyOphthalmicOrthopedicPhysical medicineGeneral hospitalEar, nose and throatClass IClass II
Instrumed International Inc dba Avalign German Specialty Instruments
Contract manufacturer · Schaumburg, IL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1421101 (openFDA record; or search FDA's registration database)
- FEI number
- 1421101
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer; Repackager or relabeler
- Owner or operator
- Avalign Technologies (FDA owner/operator no. 10051835)
- Registered address
- 626 Cooper Ct, Schaumburg, IL 60173
- Contract listings
- 216 device listings, 213 product codes, first listed May 9, 2016
- 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 |
|---|---|---|---|---|---|
| BWB | Forceps, Tube Introduction | Class I | Anesthesiology | Contract manufacturing | Nov 21, 2016 |
| DWP | Dilator, Vessel, Surgical | Class II | Cardiovascular | Contract manufacturing | Sep 21, 2016 |
| DWS | Instruments, Surgical, Cardiovascular | Class I | Cardiovascular | Contract manufacturing | Nov 16, 2016 |
| DXC | Clamp, Vascular | Class II | Cardiovascular | Contract manufacturing | Sep 21, 2016 |
| DZN | Instruments, Dental Hand | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EAX | Mirror, Mouth | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EFL | Forceps, Dressing, Dental | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EHO | Bar, Preformed | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EIG | Retractor, All Types | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EIL | Gauge, Depth, Instrument, Dental | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EJB | Handle, Instrument, Dental | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EJY | Pliers, Operative | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EKD | Instrument, Cutting, Operative | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EKT | Curette, Endodontic | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EMF | Knife, Surgical | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| EMG | Forceps, Tooth Extractor, Surgical | Class I | Dental | Contract manufacturing | Nov 21, 2016 |
| EMH | Forceps, Rongeur, Surgical | Class I | Dental | Contract manufacturing | Nov 21, 2016 |
| EMI | File, Bone, Surgical | Class I | Dental | Contract manufacturing | Nov 16, 2016 |
| EMJ | Elevator, Surgical, Dental | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EMK | Curette, Surgical, Dental | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EML | Chisel, Bone, Surgical | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EMM | Chisel, Osteotome, Surgical | Class I | Dental | Contract manufacturing | Nov 17, 2016 |
| EPY | Speculum, Ent | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| EYR | Tourniquet, Gastro-Urology | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| FBS | Sound, Metal, Interconnected | Class I | Gastroenterology and urology | Contract manufacturing | Nov 17, 2016 |
| FFN | Clamp, Non-Electrical | Class I | Gastroenterology and urology | Contract manufacturing | Nov 21, 2016 |
| FFO | Retractor, Self-Retaining | Class I | Gastroenterology and urology | Contract manufacturing | Nov 16, 2016 |
| FGN | Retractor, Non-Self-Retaining | Class I | Gastroenterology and urology | Contract manufacturing | Nov 17, 2016 |
| FHN | Ligator, Hemorrhoidal | Class II | Gastroenterology and urology | Contract manufacturing | Sep 21, 2016 |
| FHQ | Holder, Needle, Gastroenterologic | Class I | Gastroenterology and urology | Contract manufacturing | Nov 16, 2016 |
| FHR | Needle, Gastro-Urology | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| FTX | Mirror, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| FTY | Tape, Measuring, Rulers And Calipers | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| FXE | Speculum, Non-Illuminated | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| FXG | Specula Accessories | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| FZO | Chisel, Surgical, Manual | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| FZS | Curette, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Nov 21, 2016 |
| FZT | Cutter, Surgical | Class I | General and plastic surgery | Contract manufacturing | Nov 21, 2016 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Nov 21, 2016 |
| FZY | Hammer, Surgical | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| FZZ | Marker, Skin | Class I | General and plastic surgery | Contract manufacturing | Nov 21, 2016 |
| GAC | Rasp, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | May 9, 2016 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | May 9, 2016 |
| GAF | Spatula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| GAH | Stylet, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Nov 21, 2016 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Sep 21, 2016 |
| GDG | Hook, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| GDH | Gouge, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| GDI | Dissector, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Nov 21, 2016 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| GDL | Needle, Suturing, Reusable | Class I | General and plastic surgery | Contract manufacturing | Nov 21, 2016 |
| GDM | Needle, Aspiration And Injection, Reusable | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| GDN | Knife, Amputation | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| GDO | Applier, Surgical, Clip | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| GDR | Saw, Manual And Accessories | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| GDZ | Handle, Scalpel | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| GEA | Cannula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| GEG | Elevator, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Sep 21, 2016 |
| GEJ | Carrier, Ligature | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| GEN | Forceps, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| GFI | Osteotome, Manual | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| GWX | Fork, Tuning | Class I | Neurology | Contract manufacturing | Nov 21, 2016 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | Class II | Neurology | Contract manufacturing | Sep 21, 2016 |
| GZX | Instrument, Microsurgical | Class I | Neurology | Contract manufacturing | Nov 17, 2016 |
| HAE | Rongeur, Manual | Class II | Neurology | Contract manufacturing | Sep 21, 2016 |
| HAO | Instrument, Surgical, Non-Powered | Class I | Neurology | Contract manufacturing | Nov 16, 2016 |
| HAS | Needle, Neurosurgical Suture | Class I | Neurology | Contract manufacturing | Nov 17, 2016 |
| HCF | Instrument, Ligature Passing And Knot Tying | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| HCY | Curette, Uterine | Class I | Obstetrics and gynecology | Contract manufacturing | Nov 21, 2016 |
| HCZ | Forceps, Surgical, Gynecological | Class II | Obstetrics and gynecology | Contract manufacturing | Sep 21, 2016 |
| HDA | Forceps, Obstetrical | Class II | Obstetrics and gynecology | Contract manufacturing | Sep 21, 2016 |
| HDE | Hook, Fibroid, Gynecological | Class I | Obstetrics and gynecology | Contract manufacturing | Nov 17, 2016 |
| HDF | Speculum, Vaginal, Metal | Class I | Obstetrics and gynecology | Contract manufacturing | Nov 16, 2016 |
| HDJ | Scissors, Umbilical | Class I | Obstetrics and gynecology | Contract manufacturing | Nov 17, 2016 |
| HDK | Scissors, Episiotomy | Class I | Obstetrics and gynecology | Contract manufacturing | Nov 21, 2016 |
| HDL | Retractor, Vaginal | Class I | Obstetrics and gynecology | Contract manufacturing | Nov 17, 2016 |
| HDQ | Dilator, Cervical, Fixed Size | Class I | Obstetrics and gynecology | Contract manufacturing | Nov 17, 2016 |
| HFB | Forceps, Biopsy, Gynecological | Class I | Obstetrics and gynecology | Contract manufacturing | Nov 16, 2016 |
| HGC | Clamp, Uterine | Class I | Obstetrics and gynecology | Contract manufacturing | Nov 21, 2016 |
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | Class I | Obstetrics and gynecology | Contract manufacturing | Nov 21, 2016 |
| HHM | Sound, Uterine | Class I | Obstetrics and gynecology | Contract manufacturing | Nov 21, 2016 |
| HMR | Marker, Ocular | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HMX | Cannula, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HNA | Spud, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 17, 2016 |
| HNC | Specula, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 17, 2016 |
| HND | Spatula, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HNE | Snare, Enucleating | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HNF | Scissors, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 15, 2016 |
| HNH | Ring, Ophthalmic (Flieringa) | Class I | Ophthalmic | Contract manufacturing | Nov 17, 2016 |
| HNI | Retractor, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HNJ | Punch, Corneo-Scleral | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HNK | Probe, Trabeculotomy | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HNL | Probe, Lachrymal | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HNM | Needle, Ophthalmic Suturing | Class I | Ophthalmic | Contract manufacturing | Nov 21, 2016 |
| HNN | Knife, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HNP | Introducer, Sphere | Class I | Ophthalmic | Contract manufacturing | Nov 17, 2016 |
| HNQ | Hook, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HNR | Forceps, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 15, 2016 |
| HNW | Dilator, Lachrymal | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HNX | Depressor, Orbital | Class I | Ophthalmic | Contract manufacturing | Nov 17, 2016 |
| HNY | Cystotome | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HNZ | Curette, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HOB | Clamp, Muscle, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 17, 2016 |
| HOE | Caliper, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class I | Ophthalmic | Contract manufacturing | Nov 21, 2016 |
| HRH | Trephine, Manual, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 16, 2016 |
| HRQ | Hemostat | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| HRR | Scissors, Orthopedic, Surgical | Class I | Orthopedic | Contract manufacturing | Nov 17, 2016 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Nov 21, 2016 |
| HRT | Stripper, Surgical | Class I | Orthopedic | Contract manufacturing | Nov 17, 2016 |
| HRX | Arthroscope | Class II | Orthopedic | Contract manufacturing | Nov 21, 2016 |
| HTC | Pliers, Surgical | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| HTD | Forceps | Class I | General and plastic surgery | Contract manufacturing | Sep 21, 2016 |
| HTF | Curette | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Nov 17, 2016 |
| HTP | File | Class I | Orthopedic | Contract manufacturing | Nov 21, 2016 |
| HTR | Rasp | Class I | General and plastic surgery | Contract manufacturing | Mar 28, 2018 |
| HTS | Knife, Orthopedic | Class I | Orthopedic | Contract manufacturing | Nov 21, 2016 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Nov 17, 2016 |
| HTX | Rongeur | Class I | Orthopedic | Contract manufacturing | Nov 16, 2016 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Nov 17, 2016 |
| HTZ | Instrument, Cutting, Orthopedic | Class I | General and plastic surgery | Contract manufacturing | Nov 21, 2016 |
| HWA | Impactor | Class I | Orthopedic | Contract manufacturing | Nov 16, 2016 |
| HWB | Extractor | Class I | Orthopedic | Contract manufacturing | Nov 16, 2016 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Nov 21, 2016 |
| HWI | Corkscrew | Class I | Orthopedic | Contract manufacturing | Nov 17, 2016 |
| HWJ | Awl | Class I | Orthopedic | Contract manufacturing | Nov 16, 2016 |
| HWL | Set, Hollow Mill | Class I | Orthopedic | Contract manufacturing | Apr 21, 2017 |
| HWM | Osteotome | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| HWQ | Passer | Class I | Orthopedic | Contract manufacturing | Nov 21, 2016 |
| HWR | Driver, Prosthesis | Class I | Orthopedic | Contract manufacturing | Nov 21, 2016 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | May 9, 2016 |
| HWX | Tap, Bone | Class I | Orthopedic | Contract manufacturing | Nov 21, 2016 |
| HXB | Probe | Class I | Orthopedic | Contract manufacturing | Nov 17, 2016 |
| HXD | Clamp | Class I | General and plastic surgery | Contract manufacturing | Nov 21, 2016 |
| HXE | Fork | Class I | Orthopedic | Contract manufacturing | Nov 21, 2016 |
| HXG | Tamp | Class I | Orthopedic | Contract manufacturing | Nov 16, 2016 |
| HXK | Holder, Needle; Orthopedic | Class I | Orthopedic | Contract manufacturing | Nov 17, 2016 |
| HXP | Instrument, Bending Or Contouring | Class I | Orthopedic | Contract manufacturing | Nov 17, 2016 |
| HXS | Twister, Wire | Class I | Orthopedic | Contract manufacturing | Nov 17, 2016 |
| HXW | Bender | Class I | Orthopedic | Contract manufacturing | Nov 21, 2016 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Nov 17, 2016 |
| HXY | Brace, Drill | Class I | Orthopedic | Contract manufacturing | Nov 17, 2016 |
| HXZ | Cutter, Wire | Class I | Orthopedic | Contract manufacturing | Nov 16, 2016 |
| ILH | Splint, Hand, And Components | Class I | Physical medicine | Contract manufacturing | Nov 17, 2016 |
| JDW | Pin, Fixation, Threaded | Class II | Orthopedic | Contract manufacturing | Nov 17, 2016 |
| JOL | Catheter And Tip, Suction | Class II | General hospital | Contract manufacturing | Sep 21, 2016 |
| JYE | Chisel, Middle-Ear | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| JYF | Clamp, Ossicle Holding | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| JYG | Curette, Ear | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| JYH | Excavator, Ear | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| JYJ | Gauge, Measuring | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| JYL | Hook, Microsurgical Ear | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| JYQ | Loop, Wire | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| JYR | Nipper, Malleus | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| JYT | Pick, Microsurgical Ear | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| JYY | Rasp, Ear | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| JYZ | Rod, Measuring Ear | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| JZB | Scissors, Ear | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| JZD | Snare, Ear | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| JZF | Tube, Ear Suction | Class I | Ear, nose and throat | Contract manufacturing | Nov 16, 2016 |
| JZY | Knife, Laryngeal | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KAD | Elevator, Ent | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KAE | Forceps, Ent | Class I | Ear, nose and throat | Contract manufacturing | Nov 16, 2016 |
| KAI | Mirror, Ent | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| KAJ | Mobilizer, Ent | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| KAK | Probe, Ent | Class I | Ear, nose and throat | Contract manufacturing | Nov 16, 2016 |
| KAL | Retractor, Ent | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| KAN | Chisel, Nasal | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| KAO | Curette, Ethmoid | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| KAP | Curette, Nasal | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| KAQ | Gouge, Nasal, Ent | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KAR | Irrigator, Sinus | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KAS | Knife, Nasal | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| KAW | Punch, Antrum | Class I | Ear, nose and throat | Contract manufacturing | Nov 16, 2016 |
| KBA | Rasp, Nasal | Class I | Ear, nose and throat | Contract manufacturing | Nov 16, 2016 |
| KBB | Rongeur, Nasal | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KBD | Scissors, Nasal | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KBE | Snare, Nasal | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KBH | Adenotome | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KBJ | Curette, Adenoid | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KBL | Depressor, Metal Tongue, Surgical | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KBN | Gag, Mouth | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| KBP | Hook, Tonsil Suturing | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KBR | Needle, Tonsil Suturing | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| KBS | Punch, Adenoid | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KBZ | Snare, Tonsil | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| KCA | Tonsillectome | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KCB | Tube, Tonsil Suction | Class I | Ear, nose and throat | Contract manufacturing | Nov 16, 2016 |
| KCH | Hook, Tracheal | Class I | Ear, nose and throat | Contract manufacturing | Nov 21, 2016 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General hospital | Contract manufacturing | Sep 21, 2016 |
| KDG | Chisel (Osteotome) | Class I | General and plastic surgery | Contract manufacturing | Nov 21, 2016 |
| KIK | Hook, Bone | Class I | General and plastic surgery | Contract manufacturing | Nov 21, 2016 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Class I | Gastroenterology and urology | Contract manufacturing | Nov 17, 2016 |
| KQW | Goniometer, Nonpowered | Class I | Orthopedic | Contract manufacturing | Nov 21, 2016 |
| KTE | Trocar, Ent | Class I | Ear, nose and throat | Contract manufacturing | Nov 16, 2016 |
| KTF | Punch, Ent | Class I | Ear, nose and throat | Contract manufacturing | Nov 16, 2016 |
| KTG | Knife, Ent | Class I | Ear, nose and throat | Contract manufacturing | Nov 16, 2016 |
| KTZ | Caliper | Class I | Orthopedic | Contract manufacturing | Nov 21, 2016 |
| LGG | Instrument, Cast Application/Removal, Manual | Class I | Orthopedic | Contract manufacturing | Nov 16, 2016 |
| LRC | Instrument, Ent Manual Surgical | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| LRW | Scissors, General, Surgical | Class I | General and plastic surgery | Contract manufacturing | Nov 16, 2016 |
| LRY | Punch, Surgical | Class I | General and plastic surgery | Contract manufacturing | Nov 21, 2016 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | May 9, 2016 |
| LYS | Bone Mill | Class I | Orthopedic | Contract manufacturing | Nov 21, 2016 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Nov 17, 2016 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract manufacturing | Apr 4, 2018 |
| NNN | Crimper, Wire, Ent, Non-Sterile | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| NNR | Block, Cutting, Ent, Non-Sterile | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| NNU | Scissors, Wire Cutting, Ent, Non-Sterile | Class I | Ear, nose and throat | Contract manufacturing | Nov 17, 2016 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Nov 21, 2016 |