GDY · Class I · 21 CFR 878.4450

FDA Product Code GDY: Gauze/sponge, Internal, X-ray Detectable

Leading manufacturers include Lorrex Health Products, Ultracell Medical Technologies, Inc. and Thantex Specialties, Inc..

111
Total
111
Cleared
72d
Avg days
1977
Since
111 devices
49–72 of 111
Cleared Aug 06, 1992
SURGICAL SPONGES
K920356
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 192d
Cleared Jul 23, 1992
DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED
K913302
Carwild Corp.
General & Plastic Surgery · 364d
Cleared Nov 27, 1991
SUAN FLAT DISSECTOR SPONGES
K914082
Icn Pharmaceuticals, Inc.
General & Plastic Surgery · 77d
Cleared Nov 20, 1991
SIMPEX INC. SURGICAL DRESSING
K913794
Simpex, Inc.
General & Plastic Surgery · 89d
Cleared Oct 09, 1991
ICAN K DISSECTOR SPONGES
K914083
Icn Pharmaceuticals, Inc.
General & Plastic Surgery · 28d
Cleared Mar 06, 1991
LAPAROTOMY SPONGES
K905135
American Healthcare Corp.
General & Plastic Surgery · 111d
Cleared Nov 29, 1990
ADVANCE LAPAROTOMY SPONGE, LAP SPONGE
K903358
Advance Medical Designs, Inc.
General & Plastic Surgery · 126d
Cleared Nov 03, 1989
X-RAY DETECTABLE GAUZE SPONGE
K895372
Keilei Intl., Inc.
General & Plastic Surgery · 66d
Cleared Sep 05, 1989
MASCOT LAB SPONGE
K894984
Mascot, Inc.
General & Plastic Surgery · 28d
Cleared Dec 09, 1988
QUALTEX NEUROLOK SURGICAL SPONGE
K884790
Deroyal Industries, Inc.
General & Plastic Surgery · 24d
Cleared Aug 03, 1988
GAUZE PACKING, X-RAY DETECTABLE
K882707
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
GAUZE SPONGE, X-RAY DETECTABLE
K882708
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
TONSIL SPONGE, X-RAY DETECTABLE, W/STRING
K882709
Bioseal
General & Plastic Surgery · 37d
Cleared Sep 11, 1987
MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8
K873391
Ormed Mfg., Inc.
General & Plastic Surgery · 18d
Cleared Aug 04, 1987
NON-WOVEN TRACHEOTOMY SPONGE
K872807
American Silk Sutures, Inc.
General & Plastic Surgery · 21d
Cleared Aug 04, 1987
GAUZE CHERRY SPONGE
K872809
American Silk Sutures, Inc.
General & Plastic Surgery · 21d
Cleared Dec 16, 1986
LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36
K864529
Elof Hansson, Inc.
General & Plastic Surgery · 29d
Cleared Oct 14, 1986
DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000
K863089
Lifestream Int'L, Inc.
General & Plastic Surgery · 62d
Cleared Dec 17, 1985
X-RAY DETECTABLE COTTON BALLS
K854714
American Silk Sutures, Inc.
General & Plastic Surgery · 25d
Cleared Oct 08, 1985
GAUZE SPONGE
K853742
South Mountain Medical
General & Plastic Surgery · 32d
Cleared Aug 15, 1984
GAUZE & LAB SPONGES STERILE & NON
K842572
Ulti-Med Intl., Inc.
General & Plastic Surgery · 43d
Cleared Apr 23, 1984
NEURO SPONGE
K840541
Surgicot, Inc.
General & Plastic Surgery · 75d
Cleared Feb 17, 1984
FLORET FOAM PREP SPONGE
K833626
Ritmed, Inc.
General & Plastic Surgery · 126d
Cleared Oct 31, 1983
STRUNG NEURO SPONGE PATTIES-X-RAY-
K831914
Ormed Mfg., Inc.
General & Plastic Surgery · 139d