Data / Medical devices / United Kingdom / Safeguard Medical Technologies Ltd
Safeguard Medical Technologies Ltd: FDA-registered device maker in Hereford Herefordshire, United Kingdom, 1 510(k) clearance
Safeguard Medical Technologies Ltd is registered with the FDA (registration 3011657181) in Hereford Herefordshire, United Kingdom. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 25, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011657181
- Address
- Unit G Moreton Business Park Moreton-On-Lugg, Hereford Herefordshire, United Kingdom, HR4 8DS
- Owner or operator
- Safeguard US Operating LLC (10048998)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- March 30, 2015
- Registered through
- 2026
- Brand names listed
- ChitoGauze XR Pro, FullStop, Nasal Airway, OmniSplint, Pelvic Splint, Prometheus Traction Splint, Russell Chest Seal, Russell PneumoFix and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Nasopharyngeal | BTQ | 1 | Specification developer | accessdata.fda.gov |
| Belt, Pelvic, Traction | HSQ | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Specification developer | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Specification developer | accessdata.fda.gov |
| Needle, Catheter | GCB | 1 | Specification developer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Specification developer | accessdata.fda.gov |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | 1 | Specification developer | accessdata.fda.gov |
| Splint, Traction | HSP | 1 | Specification developer | accessdata.fda.gov |
| Stretcher, Hand-Carried | FPP | 1 | Specification developer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 25, 2016 | K153582 | Prometheus ChitoGauze XR PRO | QSY | Substantially Equivalent | Hem Con Medical Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Splint, Traction
- All makers of Airway, Nasopharyngeal
- All makers of Needle, Catheter
- All makers of Stretcher, Hand-Carried
- All makers of Splint, Extremity, Non-Inflatable, External, Non-Sterile
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Updated May 25, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.