Panels › General, Plastic Surgery › Product code NAB · Class 1
Gauze / Sponge,Nonresorbable For External Use
Regulation 878.4014
0510(k)s in 12 months (88 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in NAB
| Company | 510(k)s | Recalls |
|---|---|---|
| Stan-Pak Ent. | 9 | 0 |
| Cal West Trading Co. | 8 | 0 |
| Hermitage Hospital Products, Inc. | 4 | 0 |
| Kerma Medical Products, Inc. | 4 | 0 |
| Kendall Research Center | 3 | 0 |
| North Health Care | 3 | 0 |
| Pac-Kit Safety Equipment Co. | 3 | 0 |
| Ulti-Med Intl., Inc. | 3 | 0 |
| Abco Dealers, Inc. | 2 | 0 |
| Hartmann USA, Inc | 0 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 1995 | K946015 | IVALON EXTERNAL SPONGE Ivalon | NAB |
| May 2, 1994 | K940755 | ISOLYER (4X4, 8PLY) Isolyer Co. | NAB |
| Jun 24, 1993 | K931610 | OMNISORB II, NONWOVEN SPONGE, STERILE AND NON Omni Mfg., Inc. | NAB |
| Apr 8, 1993 | K925590 | MULTI-TRAUMA DRESSING Gam Industries, Inc. | NAB |
| Mar 19, 1993 | K926072 | K-BAND AND K-CREPE Parema , Ltd., GB | NAB |
| Jan 27, 1993 | K915591 | STERILE GAUZE PADS Eagle Medical, Inc. | NAB |
| Jan 11, 1993 | K924650 | GAUZE SPONGES Dav-Mar Medical Products, Inc. | NAB |
| Dec 7, 1992 | K923602 | ABSORBENT PAD -- MODIFICATION Winfield Laboratories, Inc. | NAB |
| Nov 23, 1992 | K923115 | CLINISORB Hermitage Hospital Products, Inc. | NAB |
| Oct 6, 1992 | K923378 | USP TYPE VII GAUZE SPONGES E.W.A., Ltd. | NAB |
| Oct 6, 1992 | K923116 | COMBINE II WETPROOF PAD Hermitage Hospital Products, Inc. | NAB |
| Sep 11, 1992 | K923846 | BURN DRESSING Medical Action Industries, Inc. | NAB |
| May 29, 1992 | K921227 | TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE Courtaulds Fibers, Inc. | NAB |
| May 29, 1992 | K920282 | PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE Trinity Laboratories, Inc. | NAB |
| May 29, 1992 | K915821 | MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES Kerma Medical Products, Inc. | NAB |
| Apr 22, 1992 | K920269 | EZ GAUZE SPONGE Cal West Trading Co. | NAB |
| Mar 26, 1992 | K915822 | MULTIPLE DRESSING, STERILE NONADDHERENT PADS Kerma Medical Products, Inc. | NAB |
| Mar 25, 1992 | K914604 | MEPITEL NON-ADHERENT SILICONE DRESSING Molnlycke Clinical Products AB | NAB |
| Dec 4, 1991 | K914937 | STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES Kerma Medical Products, Inc. | NAB |
| Dec 4, 1991 | K914842 | GAUZE BANDAGE ROLL Cal West Trading Co. | NAB |
| Dec 4, 1991 | K914431 | ABSORBENT FIBER Ulti-Med Intl., Inc. | NAB |
| Dec 4, 1991 | K914071 | MULTIPLE BURN DRESSING Kerma Medical Products, Inc. | NAB |
| Dec 4, 1991 | K913779 | BANDAGE ROLL, GAUZE Keilei Intl., Inc. | NAB |
| Oct 4, 1991 | K912952 | BANDAGE COMPRESS Cal West Trading Co. | NAB |
| Oct 4, 1991 | K912950 | COMPRESS DRESSING Cal West Trading Co. | NAB |
| Oct 4, 1991 | K912693 | POST OPERATIVE SPONGE Ulti-Med Intl., Inc. | NAB |
| Oct 4, 1991 | K912692 | CONFORMING BANDAGE Ulti-Med Intl., Inc. | NAB |
| Sep 30, 1991 | K912953 | GAUZE COMPRESS Cal West Trading Co. | NAB |
| Sep 30, 1991 | K912779 | GAUZE SPONGE,STERILE 2'S Keilei Intl., Inc. | NAB |
| Sep 10, 1991 | K912954 | STRETCH GAUZE BANDAGE Cal West Trading Co. | NAB |
| Sep 10, 1991 | K912951 | 12-PLY GAUZE PAD Cal West Trading Co. | NAB |
| Sep 6, 1991 | K912949 | TRIANGULAR BANDAGE,40 Cal West Trading Co. | NAB |
| Apr 12, 1991 | K910857 | ALLDRESS MULTI LAYERED WOUND DRESSING Scott Health Care | NAB |
| Oct 24, 1989 | K895727 | BACKGROUND SUCTION MATT Applied Medical Technologies, Inc. | NAB |
| Apr 27, 1989 | K891324 | HERMITEX SPONGE Hermitage Hospital Products, Inc. | NAB |
| Apr 17, 1989 | K891101 | NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING Smith & Nephew United, Inc. | NAB |
| Apr 7, 1989 | K890672 | ABSORBENT GAUZE ROLL Smith & Nephew United, Inc. | NAB |
| Jan 9, 1989 | K884335 | GAUZE BANDAGE 4 X 6 YDS. North Health Care | NAB |
| Jan 9, 1989 | K884334 | GAUZE BANDAGE 1 X 6 YDS. North Health Care | NAB |
| Jan 9, 1989 | K884333 | GAUZE BANDAGE 2 X 6 YDS. North Health Care | NAB |
| Oct 3, 1988 | K882115 | A-SORB Howard Medical Co. | NAB |
| Feb 24, 1987 | K870283 | 3 X 3 SPONGES, NON-STERILE The Medical Group, Inc. | NAB |
| Feb 24, 1987 | K870282 | 4 X 4 SPONGES, NON-STERILE The Medical Group, Inc. | NAB |
| Dec 29, 1986 | K864264 | TRICOTEX WOUND CONTACT LAYER DRESSING Smith & Nephew, Inc. | NAB |
| Apr 23, 1984 | K833735 | AN ODOR ABSORBENT BANDAGE American Medical Disposable, Inc. | NAB |
| Nov 28, 1983 | K833549 | PDI SURGICAL SCRUB/BRUSH T150-70 Nice-Pak Products, Inc. | NAB |
| Sep 12, 1983 | K831886 | FEMORAL CANAL SPONGE Zimmer, Inc. | NAB |
| Aug 12, 1983 | K831284 | GAUZE BANDAGE Pac-Kit Safety Equipment Co. | NAB |
| Aug 12, 1983 | K831282 | BANDAGE COMPRESS Pac-Kit Safety Equipment Co. | NAB |
| Aug 12, 1983 | K831281 | GAUZE COMPRESS Pac-Kit Safety Equipment Co. | NAB |
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