Panels › General Hospital › Product code FRL · Class 1
Fiber, Medical, Absorbent
Regulation 880.5300
0510(k)s in 12 months (19 all time)
0recalls in 12 months (6 all time)
1recalls that name a 510(k)
Top companies in FRL
| Company | 510(k)s | Recalls |
|---|---|---|
| American Hospital Supply Corp. | 4 | 0 |
| American Surgical Company | 0 | 2 |
| Medical Engineering Corp. | 2 | 0 |
| 3M Company / Medical Division | 0 | 1 |
| Associated Medical Products Co. | 1 | 0 |
| Carapace, Inc. | 1 | 0 |
| Coloplast Corp Skin Care Div | 0 | 1 |
| Dexide, Inc. | 1 | 0 |
| Icn Pharmaceuticals, Inc. | 1 | 0 |
| Jelco Laboratories | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 24, 2013 | K121898 | STAY FRESH SKIN FOLD MANAGEMENT TEXTILE Quick-Med Technologies, Inc. | FRL |
| Nov 4, 2011 | K110715 | INTERDRY SILVER Milliken Healthcare Products, LLC | FRL |
| Dec 22, 2006 | K061615 | INTERDRY TEXTILE WITH SILVER Milliken Chemical | FRL |
| Dec 2, 1993 | K931626 | CARAPACE STERILE COTTON BALLS Carapace, Inc. | FRL |
| Oct 9, 1991 | K914081 | ICAN COTTON RAYON BALLS Icn Pharmaceuticals, Inc. | FRL |
| Jul 27, 1981 | K811990 | TRACH CLEANING TRAY Associated Medical Products Co. | FRL |
| Apr 15, 1981 | K810242 | UTENSIL & PROCEDURE TRAYS American Hospital Supply Corp. | FRL |
| Mar 12, 1980 | K800277 | MEDSPEC RAYON BALLS Medspec Corp. | FRL |
| Feb 19, 1980 | K800249 | SURGITEK FOERSTER MAMMARY BANDAGE Medical Engineering Corp. | FRL |
| Feb 19, 1980 | K800248 | SURGITEK FOERSTER FACE LIFT BANDAGE Medical Engineering Corp. | FRL |
| Dec 20, 1979 | K792295 | SORBIES American Hospital Supply Corp. | FRL |
| Dec 11, 1979 | K792294 | BREAST PAD American Hospital Supply Corp. | FRL |
| Aug 3, 1979 | K791167 | DEXIDE DISPOSABLE PREP PAD Dexide, Inc. | FRL |
| Jul 27, 1978 | K780974 | BACILLUS PUMILUS Urol, Inc. | FRL |
| Oct 13, 1977 | K771712 | CATHETER DRESSING CHANCE SET Shield Laboratories, Inc. | FRL |
| Oct 4, 1977 | K771551 | I.V. PREP & CARE KIT Jelco Laboratories | FRL |
| May 23, 1977 | K770853 | STERILE COTTON Stat Medical Corp. | FRL |
| May 23, 1977 | K770588 | COTTON BALL KIT American Hospital Supply Corp. | FRL |
| Jan 28, 1977 | K761099 | DOVER HYPERALIMENTATION DRESSING CHNG KT Will Ross Co. | FRL |
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