Data / Medical devices / United States / Berkley Medical Resources, Inc.
Berkley Medical Resources, Inc.: FDA-registered device maker in Smithfield, PA, United States, 1 510(k) clearance
Berkley Medical Resources, Inc. is registered with the FDA (registration 2518423) in Smithfield, PA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 23, 1992. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2518423
- Address
- 700 Mountain View Dr, Smithfield, PA, United States, 15478
- Owner or operator
- BERKLEY MEDICAL RESOURCES, INC. (2518423)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- September 16, 1992
- Registered through
- 2026
- Brand names listed
- Klear Vision Surgical Apparel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dress, Surgical | FYE | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| October 23, 1992 | K922716 | SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509 | FXX | Substantially Equivalent | Splash Shield, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 23, 1992. 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.