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 |
|---|---|---|---|
| Sep 10, 2026 | K254246 | LT Antibacterial Foam with Silver Dressing Zhejiang Longterm Medical Technology Co., Ltd., CN | NAD |
| Mar 3, 2011 | K102403 | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL Sam Medical Products | NAD |
| May 20, 2009 | K091133 | APLION TOPICAL CARE SYSTEM Aplion Medical,Llc | NAD |
| Jun 17, 2008 | K072560 | ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) Teikoku Pharma USA, Inc. | NAD |
| Apr 23, 2008 | K080524 | CENTURION SORBAVIEW OTC Tri-State Hospital Supply Corp. | NAD |
| Feb 27, 2006 | K060046 | DERMASTREAM Enzysurge , Ltd. | NAD |
| May 6, 2002 | K020781 | WET CHAMBER Kinetic Concepts, Inc. | NAD |
| Jan 31, 2000 | K990530 | KERLIX MD ANTIMICROBIAL GAUZE DRESSING The Kendall Company, L.P. | NAD |
| Apr 12, 1999 | K990861 | WOUND DRESSING/ABD PAD, MODEL #10810 Hospital Specialty Co. | NAD |
| Apr 9, 1997 | K964534 | OTOSILK OTOLOGICAL GRAFT DRESSING Boston Medical Products, Inc. | NAD |
| Apr 29, 1996 | K960815 | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL Dumex Medical Surgical Products, Ltd., CA | NAD |
| Mar 13, 1996 | K955863 | ALLDRESS MULTI LAYERED WOUND DRESSING Molnlycke/Scott Health Care | NAD |
| Jul 31, 1995 | K952203 | OTOSILK Boston Medical Products, Inc. | NAD |
| Jun 24, 1993 | K930697 | MEDLINE STERILE GAUZE SPONGES Medline Industries, Inc. | NAD |
| Aug 2, 1991 | K912022 | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES Fraass Survival Systems, Inc. | NAD |
| Mar 6, 1991 | K905519 | MONTROSE DRESSING APPLICATORS Olemunda Pty , Ltd. | NAD |
| Jan 28, 1991 | K901853 | MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS Johnson & Johnson Medical, Inc. | NAD |
| Jun 12, 1990 | K901378 | TENSOPLUS LITE Smith & Nephew United, Inc. | NAD |
| Feb 21, 1990 | K897156 | HYDRASORB(TM) Avitar, Inc. | NAD |
| Feb 20, 1990 | K895654 | SORBEX(TM) SOFT SPONGE Fountain Pharmaceuticals, Inc. | NAD |
| Jan 19, 1990 | K895817 | HERMAL WOUND CARE KIT Stiefel Research Institute, Inc. | NAD |
| Nov 1, 1989 | K895845 | 2018 ARTERIAL/VENOUS PRESSURE DRESSING Advance Medical Designs, Inc. | NAD |
| Aug 31, 1989 | K894254 | HYPAFIX DRESSING RETENTION SHEET Smith & Nephew United, Inc. | NAD |
| Aug 1, 1989 | K892837 | STERIL-DERM TRANSPARENT WOUND DRESSING Biointerface Technologies, Inc. | NAD |
| Jun 5, 1989 | K891998 | BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52 Elwyn Industries | NAD |
| May 26, 1989 | K891459 | STERILE BURNNET PRE-CUT (VARIOUS SIZES) Western Medical, Ltd. | NAD |
| May 24, 1989 | K882558 | AREOLA/NIPPLE DRESSING Cooper Surgical/Aesthete | NAD |
| May 23, 1989 | K890603 | BEAM TECH WOUND DRESSING* Beam Tech , Ltd. | NAD |
| May 11, 1989 | K892527 | DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY Convatec, A Division of E.R. Squibb & Sons | NAD |
| May 4, 1989 | K891696 | DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING Convatec, A Division of E.R. Squibb & Sons | NAD |
| May 4, 1989 | K884791 | PERME-AID TRANSPARENT DRESSING, #11XX Nitto Denko Technical Corp. | NAD |
| Apr 27, 1989 | K890354 | TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X 3M Company | NAD |
| Apr 17, 1989 | K890940 | MODIFIED LABELING FOR POLYDERM WBC(TM) Laivan Corp. | NAD |
| Apr 17, 1989 | K885325 | FRASTEC CONFORMANT DRESSING, VARIOUS SIZES Frastec Wound Care Products, Inc. | NAD |
| Mar 23, 1989 | K883391 | POLYMER ADHESIVE BANDAGE Marion Laboratories, Inc. | NAD |
| Mar 8, 1989 | K890748 | ALLEVYN TRACHEOSTOMY DRESSING Smith & Nephew United, Inc. | NAD |
| Feb 8, 1989 | K883849 | REPLICARE (ADDITIONAL CLAIMS) United Medical | NAD |
| Jan 17, 1989 | K884440 | TECNOL VARIABLE TENSION BANDAGE Tecnol New Jersey Wound Care, Inc. | NAD |
| Nov 10, 1988 | K881426 | PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE Laboratoire Pan-Pra, CA | NAD |
| Aug 31, 1988 | K881936 | OPER-FILM-ADHESIVE MEMBRANE Iberhospitex, S.A., ES | NAD |
| Aug 31, 1988 | K881731 | AD-HEAL(TM) WOUND DRESSING Nepera, Inc. | NAD |
| Aug 26, 1988 | K882696 | DERMICEL, MONTGOMERY STRAP Bioseal | NAD |
| Jun 27, 1988 | K881988 | 3M WOUND CONTACT MATERIAL, PRODUCT #563X 3M Company | NAD |
| Apr 13, 1988 | K880153 | POLYDERM A+B(TM) Laivan Corp. | NAD |
| Apr 13, 1988 | K875253 | BFGOODRICH BIOTHANE NON-ADHERENT DRESSING The Bfgoodrich Co. | NAD |
| Apr 1, 1988 | K881050 | DUODERM(R) CGF Convatec, A Division of E.R. Squibb & Sons | NAD |
| Mar 11, 1988 | K880206 | POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER Laivan Corp. | NAD |
| Mar 11, 1988 | K874554 | ENVICLUSIVE (TM) Marion Laboratories, Inc. | NAD |
| Feb 29, 1988 | K872573 | PHARMACLUSIVE (TM) Pharmacia, Inc. | NAD |
| Feb 22, 1988 | K874480 | MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) Omikron Scientific, Ltd., IL | NAD |
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