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
25–48 of 111
Cleared May 02, 1994
ISOLYSER (8X4 12 PLY X-RAY DETECTABLE)
K940763
Thantex Specialties, Inc.
General & Plastic Surgery · 73d
Cleared Feb 07, 1994
STERILE LAPAROTOMY SPONGES
K934971
Medsurg Industries, Inc.
General & Plastic Surgery · 112d
Cleared Feb 03, 1994
NEUROLOGICAL SPONGES
K935883
Mcneil Healthcare, Inc.
General & Plastic Surgery · 56d
Cleared Feb 02, 1994
SURGICAL SPONGE X-RAY DETECTABLE
K935993
Mcneil Healthcare, Inc.
General & Plastic Surgery · 51d
Cleared Jan 31, 1994
SPECIALTY SPONGES
K935881
Mcneil Healthcare, Inc.
General & Plastic Surgery · 53d
Cleared Jan 31, 1994
TONSIL SPONGES
K935882
Mcneil Healthcare, Inc.
General & Plastic Surgery · 53d
Cleared Jan 31, 1994
X-RAY PACKING SPONGE
K935910
Mcneil Healthcare, Inc.
General & Plastic Surgery · 53d
Cleared Aug 06, 1992
SPECIALTY SPONGES
K920355
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 192d
Cleared Aug 06, 1992
SURGICAL SPONGES
K920356
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 192d
Cleared Nov 27, 1991
SUAN FLAT DISSECTOR SPONGES
K914082
Icn Pharmaceuticals, Inc.
General & Plastic Surgery · 77d
Cleared Oct 09, 1991
ICAN K DISSECTOR SPONGES
K914083
Icn Pharmaceuticals, Inc.
General & Plastic Surgery · 28d
Cleared Nov 29, 1990
ADVANCE LAPAROTOMY SPONGE, LAP SPONGE
K903358
Advance Medical Designs, Inc.
General & Plastic Surgery · 126d
Cleared Dec 09, 1988
QUALTEX NEUROLOK SURGICAL SPONGE
K884790
Deroyal Industries, Inc.
General & Plastic Surgery · 24d
Cleared Sep 11, 1987
MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8
K873391
Ormed Mfg., Inc.
General & Plastic Surgery · 18d
Cleared Oct 14, 1986
DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000
K863089
Lifestream Int'L, Inc.
General & Plastic Surgery · 62d
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
Cleared Sep 26, 1983
COLOR-EZE PRE-WASHED LAP SPONGES
K831913
Ormed Mfg., Inc.
General & Plastic Surgery · 104d
Cleared Mar 17, 1983
FLORET VAGINAL PACKING/TAMPONS
K830260
Ritmed, Inc.
General & Plastic Surgery · 51d
Cleared Feb 23, 1983
POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
K830201
American Medical Disposable, Inc.
General & Plastic Surgery · 34d
Cleared Feb 23, 1983
COTTON BALLS, X-RAY OPAQUED STRUNG & NON
K830202
American Medical Disposable, Inc.
General & Plastic Surgery · 34d
Cleared Jan 18, 1982
PARKE-DAVIS AEGIS ABOSRBENT SPONGES
K813595
Deseret Medical, Inc.
General & Plastic Surgery · 21d