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Sign in to claim this brandEngineered Medical Systems, LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 3325 Appling Rd, Bartlett, TN, 38133
- Website
- —
- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3009973336
- DUNS Number
- —
Catalogue (123)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ribbed Cushion Mask | K871851 | FDA 510(k) | Class I | Active |
| Ems Electrostatic Fliter And Hme Combination | K013122 | FDA 510(k) | Class II | Active |
| Trach Vox | K013728 | FDA 510(k) | Class II | Active |
| Ems Percussor | K913014 | FDA 510(k) | Class II | Active |
| Ems Peep Valves- Adjustable | K983920 | FDA 510(k) | Class II | Active |
| Ems Biopsy Instrument | K930083 | FDA 510(k) | Class II | Active |
| Talking Trach | K062104 | FDA 510(k) | Class II | Active |
| Endoscopy Oxygen Mask | K220533 | FDA 510(k) | Class II | Active |
| Baxter Adult/Pedi/Infant Single Use Man Resuscit | K924610 | FDA 510(k) | Class II | Active |
| Ems Hepa Filter And Hme Combinations | K013089 | FDA 510(k) | Class II | Active |
| Modification To Engineered Medical Systems Disposable Manual Resuscitator With Co2 Detection | K991953 | FDA 510(k) | Class II | Active |
| Disposable Pressure Monitor | K003497 | FDA 510(k) | Class II | Active |
| Baxter Adult/Pedi Infant Single/Use Man Resuscit | K924671 | FDA 510(k) | Class II | Active |
| Pressure Limiting Elbow | K932797 | FDA 510(k) | Class II | Active |
| Ems Mouth To Mask Resuscitators | K983919 | FDA 510(k) | Class II | Active |
| Single Use Manual Resuscitator Peep Valve | K932799 | FDA 510(k) | Class II | Active |
| Incentive Spirometer | K000314 | FDA 510(k) | Class II | Active |
| Ems Pulmonary Function Testing Filter | K013123 | FDA 510(k) | Class II | Active |
| Multi-Strap Full Face Mask | K023683 | FDA 510(k) | Class II | Active |
| Sealflex Mask | K874746 | FDA 510(k) | Class I | Active |
| Ems Nasal Cpap Mask | K972605 | FDA 510(k) | Class II | Active |
| Ems Single Use Manual Resuscitators | K912203 | FDA 510(k) | Class II | Active |
| Swivel Elbow | K000215 | FDA 510(k) | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 12, 2011 | Z-1058-2013 | — | terminated | The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. |