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

FDA 510(k) Cleared Gauze/sponge, Internal, X-ray Detectable Devices (Product Code GDY)

111 devices
1–24 of 111
Cleared Dec 17, 1997
ULTRACELL SUCTION SPONGE
K972634
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 156d
Cleared Mar 28, 1996
CPR LAP SPONGES
K960236
Custom Pack Reliability
General & Plastic Surgery · 72d
Cleared Feb 22, 1996
STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
K955599
Stryker Corp.
General & Plastic Surgery · 76d
Cleared Apr 17, 1995
ULTRACELL ORTHOPEDIC SPONGES
K950370
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Apr 17, 1995
ULTRACELL ORTHOPEDIC SPONGES
K950372
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Apr 17, 1995
ULTRACELL ORTHOPEDIC SPONGES
K950373
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Apr 13, 1995
ULTRACELL RETRACTOR COVERS
K950659
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 59d
Cleared Dec 28, 1994
KITTNER DISSECTOR
K945333
Lorrex Health Products
General & Plastic Surgery · 57d
Cleared Dec 28, 1994
CHERRY DISSECTOR
K945335
Lorrex Health Products
General & Plastic Surgery · 57d
Cleared Dec 28, 1994
ROUND STICK SPONGES, FLAT STICK SPONGES
K945553
Lorrex Health Products
General & Plastic Surgery · 48d
Cleared Dec 28, 1994
TRIANGULAR SPONGES
K945606
Lorrex Health Products
General & Plastic Surgery · 43d
Cleared Dec 28, 1994
CYLINDRICAL SPONGE
K945866
Lorrex Health Products
General & Plastic Surgery · 27d
Cleared Dec 19, 1994
OREX
K940764
Thantex Specialties, Inc.
General & Plastic Surgery · 304d
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 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

About Product Code GDY - Regulatory Context