NAB
88 FDA 510(k) clearances · Product code
61 daysmedian time to decision
128 days90th percentile
88clearances measured
FDA profile
- Official device name
- Gauze / Sponge,Nonresorbable For External Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4014
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2012: 8 · 2015: 10 · 2016: 25 · 2017: 24 · 2018: 22 · 2019: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IVALON EXTERNAL SPONGE (K946015) | Ivalon | 1995-02-27 |
| ISOLYER (4X4, 8PLY) (K940755) | Isolyer Co. | 1994-05-02 |
| OMNISORB II, NONWOVEN SPONGE, STERILE AND NON (K931610) | Omni Mfg., Inc. | 1993-06-24 |
| MULTI-TRAUMA DRESSING (K925590) | Gam Industries, Inc. | 1993-04-08 |
| K-BAND AND K-CREPE (K926072) | Parema , Ltd. | 1993-03-19 |
| STERILE GAUZE PADS (K915591) | Eagle Medical, Inc. | 1993-01-27 |
| GAUZE SPONGES (K924650) | Dav-Mar Medical Products, Inc. | 1993-01-11 |
| ABSORBENT PAD -- MODIFICATION (K923602) | Winfield Laboratories, Inc. | 1992-12-07 |
| CLINISORB (K923115) | Hermitage Hospital Products, Inc. | 1992-11-23 |
| COMBINE II WETPROOF PAD (K923116) | Hermitage Hospital Products, Inc. | 1992-10-06 |
| USP TYPE VII GAUZE SPONGES (K923378) | E.W.A., Ltd. | 1992-10-06 |
| BURN DRESSING (K923846) | Medical Action Industries, Inc. | 1992-09-11 |
| TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE (K921227) | Courtaulds Fibers, Inc. | 1992-05-29 |
| PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE (K920282) | Trinity Laboratories, Inc. | 1992-05-29 |
| MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES (K915821) | Kerma Medical Products, Inc. | 1992-05-29 |
| EZ GAUZE SPONGE (K920269) | Cal West Trading Co. | 1992-04-22 |
| MULTIPLE DRESSING, STERILE NONADDHERENT PADS (K915822) | Kerma Medical Products, Inc. | 1992-03-26 |
| MEPITEL NON-ADHERENT SILICONE DRESSING (K914604) | Molnlycke Clinical Products AB | 1992-03-25 |
| BANDAGE ROLL, GAUZE (K913779) | Keilei Intl., Inc. | 1991-12-04 |
| MULTIPLE BURN DRESSING (K914071) | Kerma Medical Products, Inc. | 1991-12-04 |
| GAUZE BANDAGE ROLL (K914842) | Cal West Trading Co. | 1991-12-04 |
| STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES (K914937) | Kerma Medical Products, Inc. | 1991-12-04 |
| ABSORBENT FIBER (K914431) | Ulti-Med Intl., Inc. | 1991-12-04 |
| BANDAGE COMPRESS (K912952) | Cal West Trading Co. | 1991-10-04 |
| CONFORMING BANDAGE (K912692) | Ulti-Med Intl., Inc. | 1991-10-04 |
| POST OPERATIVE SPONGE (K912693) | Ulti-Med Intl., Inc. | 1991-10-04 |
| COMPRESS DRESSING (K912950) | Cal West Trading Co. | 1991-10-04 |
| GAUZE COMPRESS (K912953) | Cal West Trading Co. | 1991-09-30 |
| GAUZE SPONGE,STERILE 2'S (K912779) | Keilei Intl., Inc. | 1991-09-30 |
| STRETCH GAUZE BANDAGE (K912954) | Cal West Trading Co. | 1991-09-10 |
| 12-PLY GAUZE PAD (K912951) | Cal West Trading Co. | 1991-09-10 |
| TRIANGULAR BANDAGE,40 (K912949) | Cal West Trading Co. | 1991-09-06 |
| ALLDRESS MULTI LAYERED WOUND DRESSING (K910857) | Scott Health Care | 1991-04-12 |
| BACKGROUND SUCTION MATT (K895727) | Applied Medical Technologies, Inc. | 1989-10-24 |
| HERMITEX SPONGE (K891324) | Hermitage Hospital Products, Inc. | 1989-04-27 |
| NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING (K891101) | Smith & Nephew United, Inc. | 1989-04-17 |
| ABSORBENT GAUZE ROLL (K890672) | Smith & Nephew United, Inc. | 1989-04-07 |
| GAUZE BANDAGE 1 X 6 YDS. (K884334) | North Health Care | 1989-01-09 |
| GAUZE BANDAGE 2 X 6 YDS. (K884333) | North Health Care | 1989-01-09 |
| GAUZE BANDAGE 4 X 6 YDS. (K884335) | North Health Care | 1989-01-09 |
| A-SORB (K882115) | Howard Medical Co. | 1988-10-03 |
| 3 X 3 SPONGES, NON-STERILE (K870283) | The Medical Group, Inc. | 1987-02-24 |
| 4 X 4 SPONGES, NON-STERILE (K870282) | The Medical Group, Inc. | 1987-02-24 |
| TRICOTEX WOUND CONTACT LAYER DRESSING (K864264) | Smith & Nephew, Inc. | 1986-12-29 |
| AN ODOR ABSORBENT BANDAGE (K833735) | American Medical Disposable, Inc. | 1984-04-23 |
| PDI SURGICAL SCRUB/BRUSH T150-70 (K833549) | Nice-Pak Products, Inc. | 1983-11-28 |
| FEMORAL CANAL SPONGE (K831886) | Zimmer, Inc. | 1983-09-12 |
| GAUZE BANDAGE (K831284) | Pac-Kit Safety Equipment Co. | 1983-08-12 |
| BANDAGE COMPRESS (K831282) | Pac-Kit Safety Equipment Co. | 1983-08-12 |
| GAUZE COMPRESS (K831281) | Pac-Kit Safety Equipment Co. | 1983-08-12 |
| NOVA GAUZE (K830473) | American Threshold Industries, Inc. | 1983-04-15 |
| COVER-ROLL STRETCH (K823879) | Beiersdorf, Inc. | 1983-03-09 |
| MOLNLYCKE ETE STERILE NON-ADHERENT DRESS (K830166) | Lada Intl., Inc. | 1983-02-09 |
| DRESSING SPONGE (K822987) | Hermitage Hospital Products, Inc. | 1982-11-05 |
| CONVERTORS DISPOSABLE DRESSING SPONGE (K822966) | American Hospital Supply Corp. | 1982-11-05 |
| MELOLIN (K821246) | Smith & Nephew, Inc. | 1982-08-06 |
| INTERSORB DRY BURN VEST & PANTS (K822047) | Chesebrough-Pond'S U.S.A. Co. | 1982-07-28 |
| UNIFLEX (K820470) | Howmedica Corp. | 1982-06-02 |
| HOLLISTER ODOR ABSORBING WOUND PAD (K820464) | Hollister, Inc. | 1982-03-23 |
| AEGIS NON-ADHERENT DRESSING (K820413) | Professional Medical Products, Inc. | 1982-03-12 |
| DERMA-AID (K820198) | Winfield Laboratories, Inc. | 1982-03-05 |
| TOPPER SPONGES (K820108) | Stan-Pak Ent. | 1982-02-12 |
| TELFA STRIPS (K820056) | Stan-Pak Ent. | 1982-02-05 |
| SOF-ROL CAST PADDING (K820139) | Stan-Pak Ent. | 1982-02-05 |
| COMBINE PAD OR ABD (K820105) | Stan-Pak Ent. | 1982-02-05 |
| KERLIX FLUFFS (K820053) | Stan-Pak Ent. | 1982-02-04 |
| SHEET WADDING CAST PADDING (K820097) | Stan-Pak Ent. | 1982-02-04 |
| VAG PACKING (K820096) | Stan-Pak Ent. | 1982-02-04 |
| TONSIL SPONGES (K820095) | Stan-Pak Ent. | 1982-02-04 |
| ROLLER GAUZE (K820098) | Stan-Pak Ent. | 1982-02-04 |
| COMFORT CUSHION DRY BURN PAD III (K813419) | American Convertors Div., American Pharmaseal | 1982-01-22 |
| DOUBLE SEAL TUBEGUAZE STERILE BANDAGE (K813308) | Scholl, Inc. | 1981-12-29 |
| STERILE GAUZE PADS 12PLY (K812711) | Medspec Corp. | 1981-11-02 |
| TRIANGULAR BANDAGE (K811814) | Abco Dealers, Inc. | 1981-07-31 |
| PARKE-DAVIS NON-WOVEN SPONGE (K810318) | Hospital Products Co. | 1981-02-26 |
| BONE-DRI SURGICAL SPONGE (K803125) | Howmedica Corp. | 1981-01-15 |
| TENDER-SORB DRAIN SPONGES (K802225) | Kendall Research Center | 1980-09-26 |
| GUAZE BANDAGES CAT.#101-169 (K801996) | Pollak (Intl.), Ltd. | 1980-09-16 |
| HYDROGEL-PREP (K791726) | Spenco Medical Corp. | 1979-11-20 |
| HAND TOWEL (K791926) | Procter & Gamble Mfg. Co. | 1979-10-17 |
| DEXIDE DISPOSABLE PREP SPONGE (K791166) | Dexide, Inc. | 1979-07-10 |
| NON-STERILE FOLDED GAUZE (K780764) | The Owenby Co. | 1978-06-06 |
| GAUZE SPONGES (K780795) | Abco Dealers, Inc. | 1978-06-06 |
| NON-STICK PADS (K780549) | National Patent Development Corp. | 1978-04-19 |
| GAUZE FLUFF (K780394) | The Torrent Corp. | 1978-04-10 |
| MICRONET LIGHT DRESSING SPONGE (K780408) | Kendall Research Center | 1978-03-22 |
| BANDAGE COMPRESS 2, 3, 4 (K770410) | Johnson & Johnson Professionals, Inc. | 1977-06-09 |
| SPONGE, CURITY WASHED GAUZE (K760094) | Kendall Research Center | 1976-07-16 |
Track NAB automatically
Every clearance here is in the API, with alerts when new ones post.