GDY · Class I · 21 CFR 878.4450

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

Leading manufacturers include Lorrex Health Products, Medical Perspectives Corp. and Ultracell Medical Technologies, Inc..

111
Total
111
Cleared
72d
Avg days
1977
Since
111 devices
25–48 of 111
Cleared Dec 19, 1994
OREX (18X18 X-RAY DETECTABLE)
K940766
Thantex Specialties, Inc.
General & Plastic Surgery · 304d
Cleared Dec 19, 1994
OREX (12X12 X-RAY DETECTABLE)
K940767
Thantex Specialties, Inc.
General & Plastic Surgery · 304d
Cleared Dec 05, 1994
ROSEBUD DISSECTOR
K945332
Lorrex Health Products
General & Plastic Surgery · 34d
Cleared Dec 05, 1994
CHERRY PIT DISSECTOR
K945334
Lorrex Health Products
General & Plastic Surgery · 34d
Cleared Dec 05, 1994
PEANUT DISSECTOR
K945336
Lorrex Health Products
General & Plastic Surgery · 34d
Cleared Jul 26, 1994
SPONGE, LAPAROTOMY, VARIOUS SIZE
K940436
Shawnee Products, Inc.
General & Plastic Surgery · 176d
Cleared May 27, 1994
LORREX GAUZE SPONGES, X-RAY DETECTABLE
K942366
Lorrex Health Products
General & Plastic Surgery · 9d
Cleared May 12, 1994
LAP SPONGE PRODUCT LINE
K941344
Cush Medical Products
General & Plastic Surgery · 56d
Cleared May 12, 1994
STERILE X-RAY DETECTABLE GAUZE SPONGES
K941522
Cush Medical Products
General & Plastic Surgery · 43d
Cleared May 02, 1994
ISOLYSER (X-RAY DETECTABLE)
K940756
Thantex Specialties, Inc.
General & Plastic Surgery · 73d
Cleared May 02, 1994
ISOLYSER (4X18) X-RAY DETECTABLE
K940757
Thantex Specialties, Inc.
General & Plastic Surgery · 73d
Cleared May 02, 1994
ISOLYSER (18X18 X-RAY DETECTABLE)
K940762
Thantex Specialties, Inc.
General & Plastic Surgery · 73d
Cleared May 02, 1994
ISOLYSER (8X4 12 PLY X-RAY DETECTABLE)
K940763
Thantex Specialties, Inc.
General & Plastic Surgery · 73d
Cleared Apr 21, 1994
DUPAQUE SPONGE
K941217
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 38d
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 Dec 09, 1993
TENCEL X-RAY DETECTABLE SPONGES/LAP PADS
K932846
Courtaulds Fibers, Inc.
General & Plastic Surgery · 182d
Cleared Aug 10, 1992
STERILE GAUZE SPONGES X-RAY DETECTABLE
K922054
Team Mfg., Inc.
General & Plastic Surgery · 98d
Cleared Aug 06, 1992
LAP SPONGES, MODIFIED
K913303
Carwild Corp.
General & Plastic Surgery · 378d
Cleared Aug 06, 1992
SPECIALTY SPONGES
K920355
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 192d