American White Cross, Inc.
Stamford, CT, US
American White Cross, Inc. appears in FDA device records in Stamford, CT. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for American White Cross, Inc. between 1985 and 1997. The busiest year on record is 1985, with 6. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 6 |
| 1986 | 1 |
| 1990 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K964614 | ULTRAFERA WOUND DRESSING | KMF | Substantially Equivalent | |
| K962400 | AIR MAX EXTERNAL NASAL DILATOR STRIP | LWF | Substantially Equivalent | |
| K894802 | AWC BUTTERFLY WOUND CLOSURES | FPX | Substantially Equivalent | |
| K854809 | WHITE CROSS STERILE PAD 4IN. X 4IN. | Substantially Equivalent | ||
| K853558 | DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ | Substantially Equivalent | ||
| K853334 | NON-ADHERA ADHESIVE PAD 3X4 | NAD | Substantially Equivalent | |
| K852412 | NON-ADHERENT PAD | EFQ | Substantially Equivalent | |
| K852408 | EXTRA LARGE ADHESIVE STRIPS | KGX | Substantially Equivalent | |
| K852462 | TRICOT ADHESIVE BANDAGE | KGX | Substantially Equivalent | |
| K850595 | 3 X 4 NON-ADHERENT PAD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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