NAB · Class I · 21 CFR 878.4014

FDA Product Code NAB: Gauze / Sponge,nonresorbable For External Use

Leading manufacturers include Stan-Pak Ent., Cal West Trading Co. and Hermitage Hospital Products, Inc..

88
Total
88
Cleared
69d
Avg days
1976
Since

FDA 510(k) Cleared Gauze / Sponge,nonresorbable For External Use Devices (Product Code NAB)

88 devices
1–24 of 88
Cleared Feb 27, 1995
IVALON EXTERNAL SPONGE
K946015
Ivalon
General & Plastic Surgery · 80d
Cleared May 02, 1994
ISOLYER (4X4, 8PLY)
K940755
Isolyer Co.
General & Plastic Surgery · 73d
Cleared Jun 24, 1993
OMNISORB II, NONWOVEN SPONGE, STERILE AND NON
K931610
Omni Mfg., Inc.
General & Plastic Surgery · 84d
Cleared Apr 08, 1993
MULTI-TRAUMA DRESSING
K925590
Gam Industries, Inc.
General & Plastic Surgery · 154d
Cleared Mar 19, 1993
K-BAND AND K-CREPE
K926072
Parema , Ltd.
General & Plastic Surgery · 108d
Cleared Jan 27, 1993
STERILE GAUZE PADS
K915591
Eagle Medical, Inc.
General & Plastic Surgery · 411d
Cleared Jan 11, 1993
GAUZE SPONGES
K924650
Dav-Mar Medical Products, Inc.
General & Plastic Surgery · 118d
Cleared Dec 07, 1992
ABSORBENT PAD -- MODIFICATION
K923602
Winfield Laboratories, Inc.
General & Plastic Surgery · 145d
Cleared Nov 23, 1992
CLINISORB
K923115
Hermitage Hospital Products, Inc.
General & Plastic Surgery · 151d
Cleared Oct 06, 1992
COMBINE II WETPROOF PAD
K923116
Hermitage Hospital Products, Inc.
General & Plastic Surgery · 103d
Cleared Oct 06, 1992
USP TYPE VII GAUZE SPONGES
K923378
E.W.A., Ltd.
General & Plastic Surgery · 89d
Cleared Sep 11, 1992
BURN DRESSING
K923846
Medical Action Industries, Inc.
General & Plastic Surgery · 42d
Cleared May 29, 1992
MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES
K915821
Kerma Medical Products, Inc.
General & Plastic Surgery · 151d
Cleared May 29, 1992
PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE
K920282
Trinity Laboratories, Inc.
General & Plastic Surgery · 128d
Cleared May 29, 1992
TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE
K921227
Courtaulds Fibers, Inc.
General & Plastic Surgery · 77d
Cleared Apr 22, 1992
EZ GAUZE SPONGE
K920269
Cal West Trading Co.
General & Plastic Surgery · 92d
Cleared Mar 26, 1992
MULTIPLE DRESSING, STERILE NONADDHERENT PADS
K915822
Kerma Medical Products, Inc.
General & Plastic Surgery · 87d
Cleared Mar 25, 1992
MEPITEL NON-ADHERENT SILICONE DRESSING
K914604
Molnlycke Clinical Products AB
General & Plastic Surgery · 160d
Cleared Dec 04, 1991
BANDAGE ROLL, GAUZE
K913779
Keilei Intl., Inc.
General & Plastic Surgery · 112d
Cleared Dec 04, 1991
MULTIPLE BURN DRESSING
K914071
Kerma Medical Products, Inc.
General & Plastic Surgery · 84d
Cleared Dec 04, 1991
ABSORBENT FIBER
K914431
Ulti-Med Intl., Inc.
General & Plastic Surgery · 61d
Cleared Dec 04, 1991
GAUZE BANDAGE ROLL
K914842
Cal West Trading Co.
General & Plastic Surgery · 37d
Cleared Dec 04, 1991
STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES
K914937
Kerma Medical Products, Inc.
General & Plastic Surgery · 30d
Cleared Oct 04, 1991
CONFORMING BANDAGE
K912692
Ulti-Med Intl., Inc.
General & Plastic Surgery · 108d

About Product Code NAB - Regulatory Context