Winfield Laboratories, Inc.
Richardson, TX, US
WINFIELD LABORATORIES, INC. appears in FDA device records in Richardson, TX. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Winfield Laboratories, Inc. between 1982 and 1997. The busiest year on record is 1982, with 1. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1987 | 1 |
| 1992 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973538 | N-TERFACE | MGP | Substantially Equivalent for Some Indications | |
| K923602 | ABSORBENT PAD -- MODIFICATION | NAB | Substantially Equivalent | |
| K872069 | KONTOUR ULTRA SOFT SPONGE #SS144.50 | NAD | Substantially Equivalent for Some Indications | |
| K820198 | DERMA-AID | NAB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1629057 | 1629057 | WINFIELD LABORATORIES, INC. | 1221 W Campbell Rd Ste 201, Richardson, TX 75080 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain