FDA Product Code
FDA Product Code NAD — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4020
510(k) Clearances — 108 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254246 | LT Antibacterial Foam with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | 2026-09-10 | Traditional | PDF ↗ |
| K102403 | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL | Sam Medical Products | 2011-03-03 | Traditional | PDF ↗ |
| K091133 | APLION TOPICAL CARE SYSTEM | Aplion Medical,Llc | 2009-05-20 | Traditional | PDF ↗ |
| K072560 | ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) | Teikoku Pharma USA, Inc. | 2008-06-17 | Traditional | PDF ↗ |
| K080524 | CENTURION SORBAVIEW OTC | Tri-State Hospital Supply Corp. | 2008-04-23 | Traditional | PDF ↗ |
| K060046 | DERMASTREAM | Enzysurge , Ltd. | 2006-02-27 | Traditional | PDF ↗ |
| K043063 | OXYBAND WOUND DRESSING | Oxyband Technologies, Inc. | 2005-03-24 | Traditional | PDF ↗ |
| K020781 | WET CHAMBER | Kinetic Concepts, Inc. | 2002-05-06 | Traditional | PDF ↗ |
| K990530 | KERLIX MD ANTIMICROBIAL GAUZE DRESSING | The Kendall Company, L.P. | 2000-01-31 | Traditional | PDF ↗ |
| K990861 | WOUND DRESSING/ABD PAD, MODEL #10810 | Hospital Specialty Co. | 1999-04-12 | Traditional | PDF ↗ |
| K964534 | OTOSILK OTOLOGICAL GRAFT DRESSING | Boston Medical Products, Inc. | 1997-04-09 | Traditional | PDF ↗ |
| K960815 | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL | Dumex Medical Surgical Products, Ltd. | 1996-04-29 | Traditional | PDF ↗ |
| K955863 | ALLDRESS MULTI LAYERED WOUND DRESSING | Molnlycke/Scott Health Care | 1996-03-13 | Traditional | PDF ↗ |
| K952203 | OTOSILK | Boston Medical Products, Inc. | 1995-07-31 | Traditional | PDF ↗ |
| K930697 | MEDLINE STERILE GAUZE SPONGES | Medline Industries, Inc. | 1993-06-24 | Traditional | PDF ↗ |
| K912022 | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1991-08-02 | Traditional | PDF ↗ |
| K905519 | MONTROSE DRESSING APPLICATORS | Olemunda Pty , Ltd. | 1991-03-06 | Traditional | PDF ↗ |
| K901853 | MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS | Johnson & Johnson Medical, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K901378 | TENSOPLUS LITE | Smith & Nephew United, Inc. | 1990-06-12 | Traditional | PDF ↗ |
| K897156 | HYDRASORB(TM) | Avitar, Inc. | 1990-02-21 | Traditional | PDF ↗ |
| K895654 | SORBEX(TM) SOFT SPONGE | Fountain Pharmaceuticals, Inc. | 1990-02-20 | Traditional | PDF ↗ |
| K895817 | HERMAL WOUND CARE KIT | Stiefel Research Institute, Inc. | 1990-01-19 | Traditional | PDF ↗ |
| K895845 | 2018 ARTERIAL/VENOUS PRESSURE DRESSING | Advance Medical Designs, Inc. | 1989-11-01 | Traditional | PDF ↗ |
| K894254 | HYPAFIX DRESSING RETENTION SHEET | Smith & Nephew United, Inc. | 1989-08-31 | Traditional | PDF ↗ |
| K892837 | STERIL-DERM TRANSPARENT WOUND DRESSING | Biointerface Technologies, Inc. | 1989-08-01 | Traditional | PDF ↗ |
| K891998 | BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52 | Elwyn Industries | 1989-06-05 | Traditional | PDF ↗ |
| K891459 | STERILE BURNNET PRE-CUT (VARIOUS SIZES) | Western Medical, Ltd. | 1989-05-26 | Traditional | PDF ↗ |
| K882558 | AREOLA/NIPPLE DRESSING | Cooper Surgical/Aesthete | 1989-05-24 | Traditional | PDF ↗ |
| K890603 | BEAM TECH WOUND DRESSING* | Beam Tech , Ltd. | 1989-05-23 | Traditional | PDF ↗ |
| K892527 | DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY | Convatec, A Division of E.R. Squibb & Sons | 1989-05-11 | Traditional | PDF ↗ |
| K891696 | DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING | Convatec, A Division of E.R. Squibb & Sons | 1989-05-04 | Traditional | PDF ↗ |
| K884791 | PERME-AID TRANSPARENT DRESSING, #11XX | Nitto Denko Technical Corp. | 1989-05-04 | Traditional | PDF ↗ |
| K890354 | TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X | 3M Company | 1989-04-27 | Traditional | PDF ↗ |
| K885325 | FRASTEC CONFORMANT DRESSING, VARIOUS SIZES | Frastec Wound Care Products, Inc. | 1989-04-17 | Traditional | PDF ↗ |
| K890940 | MODIFIED LABELING FOR POLYDERM WBC(TM) | Laivan Corp. | 1989-04-17 | Traditional | PDF ↗ |
| K883391 | POLYMER ADHESIVE BANDAGE | Marion Laboratories, Inc. | 1989-03-23 | Traditional | PDF ↗ |
| K890748 | ALLEVYN TRACHEOSTOMY DRESSING | Smith & Nephew United, Inc. | 1989-03-08 | Traditional | PDF ↗ |
| K883849 | REPLICARE (ADDITIONAL CLAIMS) | United Medical | 1989-02-08 | Traditional | PDF ↗ |
| K884440 | TECNOL VARIABLE TENSION BANDAGE | Tecnol New Jersey Wound Care, Inc. | 1989-01-17 | Traditional | PDF ↗ |
| K881426 | PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE | Laboratoire Pan-Pra | 1988-11-10 | Traditional | PDF ↗ |
| K881731 | AD-HEAL(TM) WOUND DRESSING | Nepera, Inc. | 1988-08-31 | Traditional | PDF ↗ |
| K881936 | OPER-FILM-ADHESIVE MEMBRANE | Iberhospitex, S.A. | 1988-08-31 | Traditional | PDF ↗ |
| K882696 | DERMICEL, MONTGOMERY STRAP | Bioseal | 1988-08-26 | Traditional | PDF ↗ |
| K881988 | 3M WOUND CONTACT MATERIAL, PRODUCT #563X | 3M Company | 1988-06-27 | Traditional | PDF ↗ |
| K875253 | BFGOODRICH BIOTHANE NON-ADHERENT DRESSING | The Bfgoodrich Co. | 1988-04-13 | Traditional | PDF ↗ |
| K880153 | POLYDERM A+B(TM) | Laivan Corp. | 1988-04-13 | Traditional | PDF ↗ |
| K881050 | DUODERM(R) CGF | Convatec, A Division of E.R. Squibb & Sons | 1988-04-01 | Traditional | PDF ↗ |
| K874554 | ENVICLUSIVE (TM) | Marion Laboratories, Inc. | 1988-03-11 | Traditional | PDF ↗ |
| K880206 | POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER | Laivan Corp. | 1988-03-11 | Traditional | PDF ↗ |
| K872573 | PHARMACLUSIVE (TM) | Pharmacia, Inc. | 1988-02-29 | Traditional | PDF ↗ |
| K874480 | MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) | Omikron Scientific, Ltd. | 1988-02-22 | Traditional | PDF ↗ |
| K874478 | DYNAFILM | Ferris Mfg. Corp. | 1988-01-14 | Traditional | PDF ↗ |
| K874470 | MWI 400 WOUND DRESSING | Med-West, Inc. | 1987-12-18 | Traditional | PDF ↗ |
| K874161 | MODIFIED USE OF TRIANGLE BANDAGE STERILE | K. W. Griffen Co. | 1987-12-04 | Traditional | PDF ↗ |
| K874291 | EPI-LOCK T.M. PRIMADERM | Derma-Lock Medical Corp. | 1987-11-10 | Traditional | PDF ↗ |
| K873277 | MITRAFLEX(TM) WOUND DRESSING | Matrix Medica, Inc. | 1987-09-17 | Traditional | PDF ↗ |
| K872988 | TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING | Smith & Nephew, Inc. | 1987-09-16 | Traditional | PDF ↗ |
| K872875 | STRETCH GAUZE BANDAGES | Abco Dealers, Inc. | 1987-09-04 | Traditional | PDF ↗ |
| K872982 | JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING | Johnson & Johnson Professionals, Inc. | 1987-08-14 | Traditional | PDF ↗ |
| K872069 | KONTOUR ULTRA SOFT SPONGE #SS144.50 | Winfield Laboratories, Inc. | 1987-07-14 | Traditional | PDF ↗ |
| K872100 | BIOFILM TRANSORBENT ULCER AND WOUND DRESSING | The Bfgoodrich Co. | 1987-06-30 | Traditional | PDF ↗ |
| K872101 | BIOFILM TRANS. POUCH ULCER & WOUND DRESSING | The Bfgoodrich Co. | 1987-06-30 | Traditional | PDF ↗ |
| K872099 | BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS. | The Bfgoodrich Co. | 1987-06-30 | Traditional | PDF ↗ |
| K871166 | ALLEVYN HYDROPHILIC POLYURETHANE DRESSING | Smith & Nephew, Inc. | 1987-06-16 | Traditional | PDF ↗ |
| K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 | I M, Inc. | 1987-05-08 | Traditional | PDF ↗ |
| K870239 | DRESSING, BURN, 24 BY 36 INCHES | Fraass Survival Systems, Inc. | 1987-02-06 | Traditional | PDF ↗ |
| K870185 | BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE) | Fraass Survival Systems, Inc. | 1987-02-06 | Traditional | PDF ↗ |
| K864688 | ARNOLD-KING PRESSURE DRESSING | Angiosystems, Inc. | 1987-01-12 | Traditional | PDF ↗ |
| K863580 | DERMATEC TRANSPARENT FILM DRESSING | Dermatec, Inc. | 1986-12-31 | Traditional | PDF ↗ |
| K863578 | DERMATEC ZONE TRANSPARENT DRESSING | Dermatec, Inc. | 1986-11-25 | Traditional | PDF ↗ |
| K864011 | EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1986-11-22 | Traditional | PDF ↗ |
| K863379 | DERMATEC BURN PADS | Dermatec, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K862935 | WOUND MANAGER(TM) - STERILE | Convatec, A Division of E.R. Squibb & Sons | 1986-08-20 | Traditional | PDF ↗ |
| K861972 | DERMISTRIP | Kells Medical, Inc. | 1986-06-27 | Traditional | PDF ↗ |
| K860085 | LYOFOAM WOUND DRESSINGS | Acme United Corp. | 1986-06-27 | Traditional | PDF ↗ |
| K854740 | PRIMADERM | Absorbent Cotton Co., Inc. | 1986-03-14 | Traditional | PDF ↗ |
| K854850 | FALKON STRETCH-STERILE | G.B.F. Industries, Inc. | 1986-01-13 | Traditional | PDF ↗ |
| K853334 | NON-ADHERA ADHESIVE PAD 3X4 | American White Cross, Inc. | 1985-08-21 | Traditional | PDF ↗ |
| K852211 | OPSITE WOUND DRESSING | Smith & Nephew, Inc. | 1985-07-23 | Traditional | PDF ↗ |
| K851383 | BLISTERFILM TRANSPARENT DRESSING | Chesebrough-Pond'S U.S.A. Co. | 1985-07-05 | Traditional | PDF ↗ |
| K851382 | CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING | Chesebrough-Pond'S U.S.A. Co. | 1985-07-05 | Traditional | PDF ↗ |
| K852091 | ALBA DRY BURN PAD | Alba-Waldensian, Inc. | 1985-06-13 | Traditional | PDF ↗ |
| K850535 | MITRATHANE DRESSING | Mitral Medical , Ltd. | 1985-06-05 | Traditional | PDF ↗ |
| K850282 | HYPAFIX POST OPERATIVE DRESSING | Smith & Nephew, Inc. | 1985-05-07 | Traditional | PDF ↗ |
| K850904 | ALBA DRY BURN DRESSING | Alba Health Care | 1985-04-17 | Traditional | PDF ↗ |
| K850076 | WOUND DRESSING MODEL ZB-6 | Thermedics, Inc. | 1985-04-15 | Traditional | PDF ↗ |
| K843200 | SITE STRIP | E-Med Corp. | 1985-03-12 | Traditional | PDF ↗ |
| K844095 | WET DRESSING WATER-STERILE | Absorbent Cotton Co., Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K843140 | ISOLATE ADHESIVE BANDAGE FOR DRY WOUND | Chesebrough-Pond'S U.S.A. Co. | 1984-11-08 | Traditional | PDF ↗ |
| K843139 | ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND | Chesebrough-Pond'S U.S.A. Co. | 1984-11-08 | Traditional | PDF ↗ |
| K842186 | ACU-DERM TRANSPARENT WOUND DRESSING | Acme United Corp. | 1984-08-24 | Traditional | PDF ↗ |
| K831703 | COVERUPS | The Urology Group | 1984-01-03 | Traditional | PDF ↗ |
| K833729 | ELASTIC BREATHABLE OVER-WRAP BANDAGE | American Medical Disposable, Inc. | 1983-12-30 | Traditional | PDF ↗ |
| K833638 | DERMATEX STERILE FINGER BANDAGE | Dermatec, Inc. | 1983-12-27 | Traditional | PDF ↗ |
| K831204 | MULTIPLE | Derma-Lock Medical Corp. | 1983-11-28 | Traditional | PDF ↗ |
| K831454 | LASTOBAND ADHESIVE BANDAGES | Smith & Nephew, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K831283 | TRIANGLE BANDAGE STERILE | Pac-Kit Safety Equipment Co. | 1983-08-12 | Traditional | PDF ↗ |
| K831611 | UNI-THANE | Carapac Systems, Inc. | 1983-06-20 | Traditional | PDF ↗ |
| K830050 | MOLNLYCKE MEPORE STERILE SELF-ADHESIVE | Lada Intl., Inc. | 1983-06-02 | Traditional | PDF ↗ |
| K830593 | ENSURE DRESSING | Warner-Lambert Co. | 1983-04-06 | Traditional | PDF ↗ |
Product code NAD · Class I · General, Plastic Surgery. Data: openFDA.