Data / Medical devices / United States / Rafael Medical Devices, LLC
Rafael Medical Devices, LLC: FDA-registered device maker in Newark, NJ, United States, 1 510(k) clearance
Rafael Medical Devices, LLC is registered with the FDA (registration 3018821071) in Newark, NJ, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 11, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018821071
- Address
- 520 Broad St, Newark, NJ, United States, 07102
- Owner or operator
- Rafael Medical Devices, LLC (10092212)
- Roles
- Specification developer
- First device listed
- December 20, 2024
- Registered through
- 2026
- Brand names listed
- APT Needle, VECTR Video Endoscopic Carpal Tunnel Release System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Specification developer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Specification developer | accessdata.fda.gov |
| Knife, Surgical | EMF | 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 |
|---|---|---|---|---|---|---|
| December 11, 2024 | K242417 | VECTR Video Endoscopic Carpal Tunnel Release System | HRX | Substantially Equivalent | Rafael Medical Devices, LLC | accessdata.fda.gov |
Compare with other makers
Updated December 11, 2024. 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.