Contract manufacturerEngineered Medical Systems, LLC (Bartlett, TN)TennesseeAnesthesiologyCardiovascularEar, nose and throatGeneral hospitalGeneral and plastic surgeryNeurologyOphthalmicOrthopedicPhysical medicineRadiologyClass IIClass IClass IIINot classified
Engineered Medical Systems, LLC
Contract manufacturer · Bartlett, TN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009973336 (openFDA record; or search FDA's registration database)
- FEI number
- 3009973336
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Engineered Medical Systems, LLC (FDA owner/operator no. 10042524)
- Registered address
- 3325 Appling Rd, Bartlett, TN 38133
- Contract listings
- 120 device listings, 99 product codes, first listed Dec 5, 2012
- 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 |
|---|---|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | Class II | Anesthesiology | Contract manufacturing | Nov 19, 2013 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class II | Anesthesiology | Contract manufacturing | Nov 19, 2013 |
| DQA | Oximeter | Class II | Cardiovascular | Contract manufacturing | Nov 19, 2013 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Class II | Cardiovascular | Contract manufacturing | Nov 19, 2013 |
| DSK | Computer, Blood-Pressure | Class II | Cardiovascular | Contract manufacturing | Nov 19, 2013 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class II | Cardiovascular | Contract manufacturing | Nov 19, 2013 |
| ETN | Stimulator, Nerve | Class II | Ear, nose and throat | Contract manufacturing | Dec 5, 2012 |
| FLL | Continuous Measurement Thermometer | Class II | General hospital | Contract manufacturing | Nov 19, 2013 |
| FLS | Monitor, Apnea, Facility Use | Class II | Anesthesiology | Contract manufacturing | Nov 19, 2013 |
| FST | Light, Surgical, Fiberoptic | Class II | General and plastic surgery | Contract manufacturing | Jan 17, 2013 |
| FSZ | Light, Surgical, Carrier | Class II | General and plastic surgery | Contract manufacturing | Nov 14, 2024 |
| FTY | Tape, Measuring, Rulers And Calipers | Class I | General and plastic surgery | Contract manufacturing | May 8, 2024 |
| FZO | Chisel, Surgical, Manual | Class I | General and plastic surgery | Contract manufacturing | Nov 21, 2025 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Dec 5, 2012 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Dec 5, 2012 |
| GDZ | Handle, Scalpel | Class I | General and plastic surgery | Contract manufacturing | Dec 5, 2012 |
| GEG | Elevator, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Oct 19, 2023 |
| GFI | Osteotome, Manual | Class I | General and plastic surgery | Contract manufacturing | Feb 15, 2023 |
| GWF | Stimulator, Electrical, Evoked Response | Class II | Neurology | Contract manufacturing | Dec 5, 2012 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Jan 17, 2013 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Class II | Neurology | Contract manufacturing | Dec 5, 2012 |
| HIX | Maxwell Spot, Ac-Powered | Class I | Ophthalmic | Contract manufacturing | Mar 8, 2013 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract manufacturing | Nov 14, 2024 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Nov 14, 2024 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Nov 14, 2024 |
| HTO | Reamer | Class I | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| HTR | Rasp | Class I | General and plastic surgery | Contract manufacturing | Feb 15, 2023 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Dec 19, 2012 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| HWA | Impactor | Class I | Orthopedic | Contract manufacturing | Feb 15, 2023 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Dec 5, 2012 |
| HWJ | Awl | Class I | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| HWX | Tap, Bone | Class I | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| HXB | Probe | Class I | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| HXD | Clamp | Class I | General and plastic surgery | Contract manufacturing | Jan 17, 2013 |
| HXG | Tamp | Class I | Orthopedic | Contract manufacturing | Nov 14, 2024 |
| HXL | Mallet | Class I | General and plastic surgery | Contract manufacturing | Dec 5, 2012 |
| HXW | Bender | Class I | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| IKN | Electromyograph, Diagnostic | Class II | Physical medicine | Contract manufacturing | Jan 17, 2013 |
| IXH | Camera, Focal Spot, Radiographic | Class I | Radiology | Contract manufacturing | Mar 19, 2024 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | Class II | Orthopedic | Contract manufacturing | Nov 19, 2013 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract manufacturing | Nov 19, 2013 |
| JDJ | Mesh, Surgical, Acetabular, Hip, Prosthesis | Class II | General and plastic surgery | Contract manufacturing | Nov 19, 2013 |
| JDO | Device, Fixation, Proximal Femoral, Implant | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| JDQ | Cerclage, Fixation | Class II | Orthopedic | Contract manufacturing | Nov 19, 2013 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| KDG | Chisel (Osteotome) | Class I | General and plastic surgery | Contract manufacturing | May 8, 2024 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| KRQ | Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Nov 14, 2024 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | Class II | Orthopedic | Contract manufacturing | Nov 14, 2024 |
| KTZ | Caliper | Class I | Orthopedic | Contract manufacturing | Dec 22, 2025 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Class II | Orthopedic | Contract manufacturing | Nov 19, 2013 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | Contract manufacturing | Nov 19, 2013 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Nov 19, 2013 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Nov 19, 2013 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Nov 19, 2013 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Class II | Orthopedic | Contract manufacturing | Nov 19, 2013 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Class II | Orthopedic | Contract manufacturing | Nov 19, 2013 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Dec 5, 2012 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract manufacturing | Nov 19, 2013 |
| MJO | Prosthesis, Intervertebral Disc | Class III | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| MLD | Monitor, St Segment With Alarm | Class II | Cardiovascular | Contract manufacturing | Nov 19, 2013 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| MSX | System, Network And Communication, Physiological Monitors | Class II | Cardiovascular | Contract manufacturing | Nov 19, 2013 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract manufacturing | Nov 14, 2024 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Dec 28, 2017 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 13, 2013 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | Class II | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Nov 28, 2017 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Nov 28, 2017 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract manufacturing | Nov 28, 2017 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | Dec 5, 2012 |
| OWI | Bone Fixation Cerclage, Sublaminar | Class II | Orthopedic | Contract manufacturing | Nov 28, 2017 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Class II | Orthopedic | Contract manufacturing | Sep 3, 2026 |
| PLF | Bone Wedge | Class II | Orthopedic | Contract manufacturing | Nov 14, 2024 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Class II | Orthopedic | Contract manufacturing | Sep 3, 2026 |
| QHP | Vertebral Body Tethering System | Not classified | Orthopedic | Contract manufacturing | Nov 21, 2025 |
| QLR | Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices | Class II | Orthopedic | Contract manufacturing | Dec 22, 2025 |