Data / Medical devices / United States / Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company
Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company: FDA-registered device maker in Manati, PR, United States, 1 510(k) clearance
Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company is registered with the FDA (registration 2650089) in Manati, PR, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 28, 1982. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2650089
- Address
- Road 686 Km 2.3 Bo. Tierras Nuevas, Manati, PR, United States, 00674
- Owner or operator
- BRISTOL-MYERS SQUIBB COMPANY (9011194)
- Roles
- Repackager or relabeler
- First device listed
- July 15, 2013
- Registered through
- 2026
- Brand names listed
- Norm-Ject
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Syringe, Piston | FMF | 2 | Repackager or relabeler | 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 28, 1982 | K821537 | HENKE DISPOSABLE SYRINGE | FMF | Substantially Equivalent | C. B. Dumont Company, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 28, 1982. 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.