Panels › General, Plastic Surgery › Product code NAD · Class 1
Dressing, Wound, Occlusive
Regulation 878.4020
1510(k)s in 12 months (107 all time)
0recalls in 12 months (19 all time)
8recalls that name a 510(k)
Top companies in NAD
| Company | 510(k)s | Recalls |
|---|---|---|
| COVIDIEN LLC | 0 | 9 |
| Chesebrough-Pond'S U.S.A. Co. | 5 | 0 |
| Smith & Nephew, Inc. | 5 | 0 |
| The Bfgoodrich Co. | 4 | 0 |
| Convatec, A Division of E.R. Squibb & Sons | 4 | 0 |
| Dermatec, Inc. | 4 | 0 |
| Fraass Survival Systems, Inc. | 4 | 0 |
| Acme United Corp. | 3 | 0 |
| ConvaTec, Inc | 0 | 3 |
| Kendall Healthcare Products Co | 0 | 3 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 14, 1988 | K874478 | DYNAFILM Ferris Mfg. Corp. | NAD |
| Dec 18, 1987 | K874470 | MWI 400 WOUND DRESSING Med-West, Inc. | NAD |
| Dec 4, 1987 | K874161 | MODIFIED USE OF TRIANGLE BANDAGE STERILE K. W. Griffen Co. | NAD |
| Nov 10, 1987 | K874291 | EPI-LOCK T.M. PRIMADERM Derma-Lock Medical Corp. | NAD |
| Sep 17, 1987 | K873277 | MITRAFLEX(TM) WOUND DRESSING Matrix Medica, Inc. | NAD |
| Sep 16, 1987 | K872988 | TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING Smith & Nephew, Inc. | NAD |
| Sep 4, 1987 | K872875 | STRETCH GAUZE BANDAGES Abco Dealers, Inc. | NAD |
| Aug 14, 1987 | K872982 | JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING Johnson & Johnson Professionals, Inc. | NAD |
| Jul 14, 1987 | K872069 | KONTOUR ULTRA SOFT SPONGE #SS144.50 Winfield Laboratories, Inc. | NAD |
| Jun 30, 1987 | K872101 | BIOFILM TRANS. POUCH ULCER & WOUND DRESSING The Bfgoodrich Co. | NAD |
| Jun 30, 1987 | K872100 | BIOFILM TRANSORBENT ULCER AND WOUND DRESSING The Bfgoodrich Co. | NAD |
| Jun 30, 1987 | K872099 | BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS. The Bfgoodrich Co. | NAD |
| Jun 16, 1987 | K871166 | ALLEVYN HYDROPHILIC POLYURETHANE DRESSING Smith & Nephew, Inc. | NAD |
| May 8, 1987 | K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 I M, Inc. | NAD |
| Feb 6, 1987 | K870239 | DRESSING, BURN, 24 BY 36 INCHES Fraass Survival Systems, Inc. | NAD |
| Feb 6, 1987 | K870185 | BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE) Fraass Survival Systems, Inc. | NAD |
| Jan 12, 1987 | K864688 | ARNOLD-KING PRESSURE DRESSING Angiosystems, Inc. | NAD |
| Dec 31, 1986 | K863580 | DERMATEC TRANSPARENT FILM DRESSING Dermatec, Inc. | NAD |
| Nov 25, 1986 | K863578 | DERMATEC ZONE TRANSPARENT DRESSING Dermatec, Inc. | NAD |
| Nov 22, 1986 | K864011 | EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES Fraass Survival Systems, Inc. | NAD |
| Sep 26, 1986 | K863379 | DERMATEC BURN PADS Dermatec, Inc. | NAD |
| Aug 20, 1986 | K862935 | WOUND MANAGER(TM) - STERILE Convatec, A Division of E.R. Squibb & Sons | NAD |
| Jun 27, 1986 | K861972 | DERMISTRIP Kells Medical, Inc. | NAD |
| Jun 27, 1986 | K860085 | LYOFOAM WOUND DRESSINGS Acme United Corp. | NAD |
| Mar 14, 1986 | K854740 | PRIMADERM Absorbent Cotton Co., Inc. | NAD |
| Jan 13, 1986 | K854850 | FALKON STRETCH-STERILE G.B.F. Industries, Inc. | NAD |
| Aug 21, 1985 | K853334 | NON-ADHERA ADHESIVE PAD 3X4 American White Cross, Inc. | NAD |
| Jul 23, 1985 | K852211 | OPSITE WOUND DRESSING Smith & Nephew, Inc. | NAD |
| Jul 5, 1985 | K851383 | BLISTERFILM TRANSPARENT DRESSING Chesebrough-Pond'S U.S.A. Co. | NAD |
| Jul 5, 1985 | K851382 | CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING Chesebrough-Pond'S U.S.A. Co. | NAD |
| Jun 13, 1985 | K852091 | ALBA DRY BURN PAD Alba-Waldensian, Inc. | NAD |
| Jun 5, 1985 | K850535 | MITRATHANE DRESSING Mitral Medical , Ltd. | NAD |
| May 7, 1985 | K850282 | HYPAFIX POST OPERATIVE DRESSING Smith & Nephew, Inc. | NAD |
| Apr 17, 1985 | K850904 | ALBA DRY BURN DRESSING Alba Health Care | NAD |
| Apr 15, 1985 | K850076 | WOUND DRESSING MODEL ZB-6 Thermedics, Inc. | NAD |
| Mar 12, 1985 | K843200 | SITE STRIP E-Med Corp. | NAD |
| Nov 27, 1984 | K844095 | WET DRESSING WATER-STERILE Absorbent Cotton Co., Inc. | NAD |
| Nov 8, 1984 | K843140 | ISOLATE ADHESIVE BANDAGE FOR DRY WOUND Chesebrough-Pond'S U.S.A. Co. | NAD |
| Nov 8, 1984 | K843139 | ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND Chesebrough-Pond'S U.S.A. Co. | NAD |
| Aug 24, 1984 | K842186 | ACU-DERM TRANSPARENT WOUND DRESSING Acme United Corp. | NAD |
| Jan 3, 1984 | K831703 | COVERUPS The Urology Group | NAD |
| Dec 30, 1983 | K833729 | ELASTIC BREATHABLE OVER-WRAP BANDAGE American Medical Disposable, Inc. | NAD |
| Dec 27, 1983 | K833638 | DERMATEX STERILE FINGER BANDAGE Dermatec, Inc. | NAD |
| Nov 28, 1983 | K831204 | MULTIPLE Derma-Lock Medical Corp. | NAD |
| Oct 31, 1983 | K831454 | LASTOBAND ADHESIVE BANDAGES Smith & Nephew, Inc. | NAD |
| Aug 12, 1983 | K831283 | TRIANGLE BANDAGE STERILE Pac-Kit Safety Equipment Co. | NAD |
| Jun 20, 1983 | K831611 | UNI-THANE Carapac Systems, Inc. | NAD |
| Jun 2, 1983 | K830050 | MOLNLYCKE MEPORE STERILE SELF-ADHESIVE Lada Intl., Inc. | NAD |
| Apr 6, 1983 | K830593 | ENSURE DRESSING Warner-Lambert Co. | NAD |
| Mar 17, 1983 | K823852 | CHESEBROUGH-POND'S MULTILAYER ELASTIC Chesebrough-Pond'S U.S.A. Co. | NAD |
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