FDA Product Code
FDA Product Code NAB — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4014
510(k) Clearances — 88 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K946015 | IVALON EXTERNAL SPONGE | Ivalon | 1995-02-27 | Traditional | PDF ↗ |
| K940755 | ISOLYER (4X4, 8PLY) | Isolyer Co. | 1994-05-02 | Traditional | PDF ↗ |
| K931610 | OMNISORB II, NONWOVEN SPONGE, STERILE AND NON | Omni Mfg., Inc. | 1993-06-24 | Traditional | PDF ↗ |
| K925590 | MULTI-TRAUMA DRESSING | Gam Industries, Inc. | 1993-04-08 | Traditional | PDF ↗ |
| K926072 | K-BAND AND K-CREPE | Parema , Ltd. | 1993-03-19 | Traditional | PDF ↗ |
| K915591 | STERILE GAUZE PADS | Eagle Medical, Inc. | 1993-01-27 | Traditional | PDF ↗ |
| K924650 | GAUZE SPONGES | Dav-Mar Medical Products, Inc. | 1993-01-11 | Traditional | PDF ↗ |
| K923602 | ABSORBENT PAD -- MODIFICATION | Winfield Laboratories, Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K923115 | CLINISORB | Hermitage Hospital Products, Inc. | 1992-11-23 | Traditional | PDF ↗ |
| K923116 | COMBINE II WETPROOF PAD | Hermitage Hospital Products, Inc. | 1992-10-06 | Traditional | PDF ↗ |
| K923378 | USP TYPE VII GAUZE SPONGES | E.W.A., Ltd. | 1992-10-06 | Traditional | PDF ↗ |
| K923846 | BURN DRESSING | Medical Action Industries, Inc. | 1992-09-11 | Traditional | PDF ↗ |
| K915821 | MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES | Kerma Medical Products, Inc. | 1992-05-29 | Traditional | PDF ↗ |
| K921227 | TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE | Courtaulds Fibers, Inc. | 1992-05-29 | Traditional | PDF ↗ |
| K920282 | PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1992-05-29 | Traditional | PDF ↗ |
| K920269 | EZ GAUZE SPONGE | Cal West Trading Co. | 1992-04-22 | Traditional | PDF ↗ |
| K915822 | MULTIPLE DRESSING, STERILE NONADDHERENT PADS | Kerma Medical Products, Inc. | 1992-03-26 | Traditional | PDF ↗ |
| K914604 | MEPITEL NON-ADHERENT SILICONE DRESSING | Molnlycke Clinical Products AB | 1992-03-25 | Traditional | PDF ↗ |
| K913779 | BANDAGE ROLL, GAUZE | Keilei Intl., Inc. | 1991-12-04 | Traditional | PDF ↗ |
| K914431 | ABSORBENT FIBER | Ulti-Med Intl., Inc. | 1991-12-04 | Traditional | PDF ↗ |
| K914937 | STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES | Kerma Medical Products, Inc. | 1991-12-04 | Traditional | PDF ↗ |
| K914842 | GAUZE BANDAGE ROLL | Cal West Trading Co. | 1991-12-04 | Traditional | PDF ↗ |
| K914071 | MULTIPLE BURN DRESSING | Kerma Medical Products, Inc. | 1991-12-04 | Traditional | PDF ↗ |
| K912693 | POST OPERATIVE SPONGE | Ulti-Med Intl., Inc. | 1991-10-04 | Traditional | PDF ↗ |
| K912950 | COMPRESS DRESSING | Cal West Trading Co. | 1991-10-04 | Traditional | PDF ↗ |
| K912692 | CONFORMING BANDAGE | Ulti-Med Intl., Inc. | 1991-10-04 | Traditional | PDF ↗ |
| K912952 | BANDAGE COMPRESS | Cal West Trading Co. | 1991-10-04 | Traditional | PDF ↗ |
| K912779 | GAUZE SPONGE,STERILE 2'S | Keilei Intl., Inc. | 1991-09-30 | Traditional | PDF ↗ |
| K912953 | GAUZE COMPRESS | Cal West Trading Co. | 1991-09-30 | Traditional | PDF ↗ |
| K912954 | STRETCH GAUZE BANDAGE | Cal West Trading Co. | 1991-09-10 | Traditional | PDF ↗ |
| K912951 | 12-PLY GAUZE PAD | Cal West Trading Co. | 1991-09-10 | Traditional | PDF ↗ |
| K912949 | TRIANGULAR BANDAGE,40 | Cal West Trading Co. | 1991-09-06 | Traditional | PDF ↗ |
| K910857 | ALLDRESS MULTI LAYERED WOUND DRESSING | Scott Health Care | 1991-04-12 | Traditional | PDF ↗ |
| K895727 | BACKGROUND SUCTION MATT | Applied Medical Technologies, Inc. | 1989-10-24 | Traditional | PDF ↗ |
| K891324 | HERMITEX SPONGE | Hermitage Hospital Products, Inc. | 1989-04-27 | Traditional | PDF ↗ |
| K891101 | NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING | Smith & Nephew United, Inc. | 1989-04-17 | Traditional | PDF ↗ |
| K890672 | ABSORBENT GAUZE ROLL | Smith & Nephew United, Inc. | 1989-04-07 | Traditional | PDF ↗ |
| K884333 | GAUZE BANDAGE 2 X 6 YDS. | North Health Care | 1989-01-09 | Traditional | PDF ↗ |
| K884335 | GAUZE BANDAGE 4 X 6 YDS. | North Health Care | 1989-01-09 | Traditional | PDF ↗ |
| K884334 | GAUZE BANDAGE 1 X 6 YDS. | North Health Care | 1989-01-09 | Traditional | PDF ↗ |
| K882115 | A-SORB | Howard Medical Co. | 1988-10-03 | Traditional | PDF ↗ |
| K870283 | 3 X 3 SPONGES, NON-STERILE | The Medical Group, Inc. | 1987-02-24 | Traditional | PDF ↗ |
| K870282 | 4 X 4 SPONGES, NON-STERILE | The Medical Group, Inc. | 1987-02-24 | Traditional | PDF ↗ |
| K864264 | TRICOTEX WOUND CONTACT LAYER DRESSING | Smith & Nephew, Inc. | 1986-12-29 | Traditional | PDF ↗ |
| K833735 | AN ODOR ABSORBENT BANDAGE | American Medical Disposable, Inc. | 1984-04-23 | Traditional | PDF ↗ |
| K833549 | PDI SURGICAL SCRUB/BRUSH T150-70 | Nice-Pak Products, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K831886 | FEMORAL CANAL SPONGE | Zimmer, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K831284 | GAUZE BANDAGE | Pac-Kit Safety Equipment Co. | 1983-08-12 | Traditional | PDF ↗ |
| K831282 | BANDAGE COMPRESS | Pac-Kit Safety Equipment Co. | 1983-08-12 | Traditional | PDF ↗ |
| K831281 | GAUZE COMPRESS | Pac-Kit Safety Equipment Co. | 1983-08-12 | Traditional | PDF ↗ |
| K830473 | NOVA GAUZE | American Threshold Industries, Inc. | 1983-04-15 | Traditional | PDF ↗ |
| K823879 | COVER-ROLL STRETCH | Beiersdorf, Inc. | 1983-03-09 | Traditional | PDF ↗ |
| K830166 | MOLNLYCKE ETE STERILE NON-ADHERENT DRESS | Lada Intl., Inc. | 1983-02-09 | Traditional | PDF ↗ |
| K822987 | DRESSING SPONGE | Hermitage Hospital Products, Inc. | 1982-11-05 | Traditional | PDF ↗ |
| K822966 | CONVERTORS DISPOSABLE DRESSING SPONGE | American Hospital Supply Corp. | 1982-11-05 | Traditional | PDF ↗ |
| K821246 | MELOLIN | Smith & Nephew, Inc. | 1982-08-06 | Traditional | PDF ↗ |
| K822047 | INTERSORB DRY BURN VEST & PANTS | Chesebrough-Pond'S U.S.A. Co. | 1982-07-28 | Traditional | PDF ↗ |
| K820470 | UNIFLEX | Howmedica Corp. | 1982-06-02 | Traditional | PDF ↗ |
| K820464 | HOLLISTER ODOR ABSORBING WOUND PAD | Hollister, Inc. | 1982-03-23 | Traditional | PDF ↗ |
| K820413 | AEGIS NON-ADHERENT DRESSING | Professional Medical Products, Inc. | 1982-03-12 | Traditional | PDF ↗ |
| K820198 | DERMA-AID | Winfield Laboratories, Inc. | 1982-03-05 | Traditional | PDF ↗ |
| K820108 | TOPPER SPONGES | Stan-Pak Ent. | 1982-02-12 | Traditional | PDF ↗ |
| K820056 | TELFA STRIPS | Stan-Pak Ent. | 1982-02-05 | Traditional | PDF ↗ |
| K820105 | COMBINE PAD OR ABD | Stan-Pak Ent. | 1982-02-05 | Traditional | PDF ↗ |
| K820139 | SOF-ROL CAST PADDING | Stan-Pak Ent. | 1982-02-05 | Traditional | PDF ↗ |
| K820096 | VAG PACKING | Stan-Pak Ent. | 1982-02-04 | Traditional | PDF ↗ |
| K820095 | TONSIL SPONGES | Stan-Pak Ent. | 1982-02-04 | Traditional | PDF ↗ |
| K820098 | ROLLER GAUZE | Stan-Pak Ent. | 1982-02-04 | Traditional | PDF ↗ |
| K820097 | SHEET WADDING CAST PADDING | Stan-Pak Ent. | 1982-02-04 | Traditional | PDF ↗ |
| K820053 | KERLIX FLUFFS | Stan-Pak Ent. | 1982-02-04 | Traditional | PDF ↗ |
| K813419 | COMFORT CUSHION DRY BURN PAD III | American Convertors Div., American Pharmaseal | 1982-01-22 | Traditional | PDF ↗ |
| K813308 | DOUBLE SEAL TUBEGUAZE STERILE BANDAGE | Scholl, Inc. | 1981-12-29 | Traditional | PDF ↗ |
| K812711 | STERILE GAUZE PADS 12PLY | Medspec Corp. | 1981-11-02 | Traditional | PDF ↗ |
| K811814 | TRIANGULAR BANDAGE | Abco Dealers, Inc. | 1981-07-31 | Traditional | PDF ↗ |
| K810318 | PARKE-DAVIS NON-WOVEN SPONGE | Hospital Products Co. | 1981-02-26 | Traditional | PDF ↗ |
| K803125 | BONE-DRI SURGICAL SPONGE | Howmedica Corp. | 1981-01-15 | Traditional | PDF ↗ |
| K802225 | TENDER-SORB DRAIN SPONGES | Kendall Research Center | 1980-09-26 | Traditional | PDF ↗ |
| K801996 | GUAZE BANDAGES CAT.#101-169 | Pollak (Intl.), Ltd. | 1980-09-16 | Traditional | PDF ↗ |
| K791726 | HYDROGEL-PREP | Spenco Medical Corp. | 1979-11-20 | Traditional | PDF ↗ |
| K791926 | HAND TOWEL | Procter & Gamble Mfg. Co. | 1979-10-17 | Traditional | PDF ↗ |
| K791166 | DEXIDE DISPOSABLE PREP SPONGE | Dexide, Inc. | 1979-07-10 | Traditional | PDF ↗ |
| K780764 | NON-STERILE FOLDED GAUZE | The Owenby Co. | 1978-06-06 | Traditional | PDF ↗ |
| K780795 | GAUZE SPONGES | Abco Dealers, Inc. | 1978-06-06 | Traditional | PDF ↗ |
| K780549 | NON-STICK PADS | National Patent Development Corp. | 1978-04-19 | Traditional | PDF ↗ |
| K780394 | GAUZE FLUFF | The Torrent Corp. | 1978-04-10 | Traditional | PDF ↗ |
| K780408 | MICRONET LIGHT DRESSING SPONGE | Kendall Research Center | 1978-03-22 | Traditional | PDF ↗ |
| K770410 | BANDAGE COMPRESS 2, 3, 4 | Johnson & Johnson Professionals, Inc. | 1977-06-09 | Traditional | PDF ↗ |
| K760094 | SPONGE, CURITY WASHED GAUZE | Kendall Research Center | 1976-07-16 | Traditional | PDF ↗ |
Product code NAB · Class I · General, Plastic Surgery. Data: openFDA.