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 Dec 19, 1995
PROTEC X-RAY DETECTABLE GAUZE SPONGE
K955322
Derivados DE Gasa, S.A. DE C.V.
General & Plastic Surgery · 29d
Cleared Oct 03, 1995
KENSORB
K953830
Kentron Health Care, Inc.
General & Plastic Surgery · 48d
Cleared Sep 14, 1995
CYLINDRICAL SPONGE
K953057
Medical Perspectives Corp.
General & Plastic Surgery · 76d
Cleared Sep 14, 1995
ROUND STICK SPONGES, FLAT STICK SPONGES
K953058
Medical Perspectives Corp.
General & Plastic Surgery · 76d
Cleared Sep 14, 1995
KITTNER DISSECTOR
K953059
Medical Perspectives Corp.
General & Plastic Surgery · 76d
Cleared Sep 14, 1995
ROSEBUD DISSECTOR
K953060
Medical Perspectives Corp.
General & Plastic Surgery · 76d
Cleared Sep 14, 1995
CHERRY DISSECTOR
K953062
Medical Perspectives Corp.
General & Plastic Surgery · 76d
Cleared Sep 14, 1995
CHERRY PIT DISSECTOR
K953087
Medical Perspectives Corp.
General & Plastic Surgery · 73d
Cleared Sep 14, 1995
TRIANGULAR SPONGES
K953088
Medical Perspectives Corp.
General & Plastic Surgery · 73d
Cleared Jun 21, 1995
GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)
K951911
Commercial Resources New Mexico, Ltd.
General & Plastic Surgery · 58d
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 23, 1994
GAUZE SPONGES
K944879
Clinical Resources, Inc.
General & Plastic Surgery · 81d
Cleared Dec 19, 1994
OREX
K940764
Thantex Specialties, Inc.
General & Plastic Surgery · 304d

About Product Code GDY - Regulatory Context