GDY · Class I · 21 CFR 878.4450

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

Leading manufacturers include Lorrex Health Products, Thantex Specialties, Inc. and Medical Perspectives Corp..

111
Total
111
Cleared
72d
Avg days
1977
Since
111 devices
73–96 of 111
Cleared Sep 26, 1983
COLOR-EZE PRE-WASHED LAP SPONGES
K831913
Ormed Mfg., Inc.
General & Plastic Surgery · 104d
Cleared Aug 12, 1983
GAUZE SPONGE X-RAY DETECTABLE-
K832172
Sudreca Surgical Dressings, Inc.
General & Plastic Surgery · 37d
Cleared Mar 17, 1983
FLORET VAGINAL PACKING/TAMPONS
K830260
Ritmed, Inc.
General & Plastic Surgery · 51d
Cleared Mar 17, 1983
ZANLEX, ZAN-TEX & ZANDEX
K830511
Winn Hirsch & Assoc.
General & Plastic Surgery · 28d
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 09, 1983
NO-GAUZE LAPAROTOMY SPONGE
K823671
Surgilite Intl., Inc.
General & Plastic Surgery · 33d
Cleared Oct 13, 1982
LAPAROTOMY SPONGE
K822623
Hermitage Hospital Products, Inc.
General & Plastic Surgery · 44d
Cleared Jan 22, 1982
PRE-PACK TENS
K813286
Cunningham Woodland, Inc.
General & Plastic Surgery · 60d
Cleared Jan 18, 1982
PARKE-DAVIS AEGIS ABOSRBENT SPONGES
K813595
Deseret Medical, Inc.
General & Plastic Surgery · 21d
Cleared Nov 24, 1981
NEUROSPONGE PADDIE
K812390
Winn Hirsch & Assoc.
General & Plastic Surgery · 96d
Cleared Nov 24, 1981
NEUROSPONGES
K812391
Winn Hirsch & Assoc.
General & Plastic Surgery · 96d
Cleared Nov 20, 1981
X-RAY DETECTABLE BAND
K812017
Isramed, Inc.
Radiology · 126d
Cleared Nov 20, 1981
X-RAY DETECTABLE THREAD
K812018
Isramed, Inc.
Radiology · 126d
Cleared Nov 06, 1981
SURGICAL DRESSINGS
K812831
Foreign Trade Zone of Wisconsin
General & Plastic Surgery · 28d
Cleared Nov 02, 1981
STERILE DISSECTOR SPONGES-X-RAY DETECT
K812707
Medspec Corp.
General & Plastic Surgery · 39d
Cleared Nov 02, 1981
STERILE LAPAROTOMY SPONGES-X-RAY DETECT
K812710
Medspec Corp.
General & Plastic Surgery · 39d
Cleared Oct 20, 1981
X-RAY DETECTABLE LAP SPONGES
K812651
Procter & Gamble Mfg. Co.
General & Plastic Surgery · 33d
Cleared Sep 24, 1981
TOMAC STERILE DISP. LAP SPONGE
K812554
American Convertors Div., American Pharmaseal
General & Plastic Surgery · 16d
Cleared Sep 11, 1981
UNSTERILIZED LAPAROTOMY SPONGES (CHINA)
K811632
Robert I. Chien & Assoc., Inc.
General & Plastic Surgery · 94d
Cleared Aug 07, 1981
LAPAROTOMY PADS
K811769
South Mountain Medical
General & Plastic Surgery · 46d
Cleared Feb 04, 1981
LAPAROTOMY SPONGE
K810184
Medical Action Industries, Inc.
General & Plastic Surgery · 13d
Cleared Jan 15, 1981
GAUZE SPONGES
K803188
Abco Dealers, Inc.
General & Plastic Surgery · 30d
Cleared Dec 19, 1980
GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG.
K802982
Stanford Laboratories
General & Plastic Surgery · 25d