Data / Medical devices / United States / Mcneil Healthcare LLC
Mcneil Healthcare LLC: FDA-registered device maker in Fairfield, NJ, United States, 3 510(k) clearances
Mcneil Healthcare LLC is registered with the FDA (registration 1223924) in Fairfield, NJ, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 31, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1223924
- FEI number
- 1000305719
- Address
- 311 Rt 46 West Unit C, Fairfield, NJ, United States, 07004
- Owner or operator
- McNeil Healthcare Packaging LLC (10083742)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 13, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fiber, Medical, Absorbent | FRL | 1 | Manufacturer | accessdata.fda.gov |
| Gauze/Sponge, Internal | EFQ | U | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 31, 1994 | K935911 | PACKING SPONGE | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 14, 1994 | K935937 | POST OP SPONGE | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 14, 1994 | K935933 | CUSTOM BURN DRESSING | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Gauze/Sponge, Internal, X-Ray Detectable
- All makers of Fiber, Medical, Absorbent
- All makers of Gauze/Sponge, Internal
Updated January 31, 1994. 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.