Data / Medical devices / United States / Bio Med Sciences, Inc.
Bio Med Sciences, Inc.: FDA-registered device maker in Allentown, PA, United States, 5 510(k) clearances
Bio Med Sciences, Inc. is registered with the FDA (registration 2529394) in Allentown, PA, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 31, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2529394
- FEI number
- 1000121500
- Address
- 999 Postal Road, Allentown, PA, United States, 18109
- Owner or operator
- BIO MED SCIENCES, INC. (9022350)
- Roles
- Specification developer
- First device listed
- July 19, 1994
- Registered through
- 2026
- Brand names listed
- Oleeva Clear, Oleeva Fabric, Oleeva Foam, Oleeva Ultra, Rylon-1, ScarAway, ScarAway Clear, Silon Dual Dress 20F and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Specification developer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Specification developer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 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 |
|---|---|---|---|---|---|---|
| August 31, 2000 | K002109 | OLEEVA FOAM | MDA | Substantially Equivalent | Bio Med Sciences, Inc. | accessdata.fda.gov |
| March 19, 1999 | K990042 | SILON DUAL-DRESS | FRO | Substantially Equivalent | Bio Med Sciences, Inc. | accessdata.fda.gov |
| August 6, 1998 | K982036 | SILON SCAR STRIPS | MDA | Substantially Equivalent | Bio Med Sciences, Inc. | accessdata.fda.gov |
| August 7, 1995 | K952546 | SILON SILICONE TEXTILE COMPOSITE | MDA | Substantially Equivalent | Bio Med Sciences, Inc. | accessdata.fda.gov |
| March 3, 1995 | K945892 | SILON(R) SILICONE THERMOPLASTIC SHEETING | MDA | Substantially Equivalent | Bio Med Sciences, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Gauze / Sponge,Nonresorbable For External Use
Updated August 31, 2000. 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.