ClearanceBrief
Product code EFQ ยท Class U

Gauze/Sponge, Internal

0510(k)s in 12 months (271 all time)
3recalls in 12 months (13 all time)
7recalls that name a 510(k)
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Top companies in EFQ

Company510(k)sRecalls
Mcneil Healthcare, Inc.140
Ormed Mfg., Inc.140
American Medical Disposable, Inc.130
Ritmed, Inc.100
Certified Safety Mfg., Inc.80
Fraass Survival Systems, Inc.80
Applied Medical60
Lorons International Corp.60
Lorrex Health Products60
Abco Dealers, Inc.50
Decided510(k)Device and applicantCode
Aug 12, 1999K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
Furlong Industries
EFQ
Jun 11, 1999K991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
Symtex Healthcare Corp.
EFQ
Jun 9, 1999K990974VITOP DRESSING
Wonder & Bioenergy Hi-Tech America, Inc.
EFQ
Apr 23, 1999K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
Broadline Medical Industries
EFQ
Feb 18, 1999K984187CROSSTEX NON-WOVEN SPONGES
Crosstex Intl.
EFQ
Feb 12, 1999K983016GAUZE, SPONGES, CAT # 11-003
Vitalcare Group, Inc.
EFQ
Dec 11, 1998K983348DYNAREX TRACHEOSTOMY SPONGE
Dynarex Corp.
EFQ
Nov 12, 1998K983450STARRYSHINE GAUZE SPONGE
T.C. Dental Products, Inc.
EFQ
Sep 30, 1998K982648JOAN II
Celanese Acetate Co.
EFQ
Apr 29, 1998K980791DUMEX PAK-ITS WOVEN RIBBON PACKING
Dumex Medical Surgical Products, Ltd., CA
EFQ
Feb 13, 1998K974316HYDROFERA FEMORAL WICK
Hydrofera, LLC
EFQ
Feb 10, 1998K974347BALDUR NON-STERILE COTTON SPONGES
Baldur Systems Corp.
EFQ
Dec 31, 1997K973763KENDALL CURITY IODOFORM PACKING STRIP
Kendall Healthcare Products Co. Div.Of Tyco Health
EFQ
Dec 10, 1997K973580INVOTEC CLEAN PAD
Invotec International, Inc.
EFQ
Nov 26, 1997K973299PIN CARE KIT
Brown Medical Industries
EFQ
Sep 16, 1997K971095OPPORTUNITY SUTURE REMOVAL KIT
Opportunity, Inc.
EFQ
Sep 16, 1997K971088OPPORTUNITY INCISION AND DRAINAGE TRAY
Opportunity, Inc.
EFQ
Jun 27, 1997K971178RAND SURGICAL SPONGE
Trans Aire
EFQ
Jun 22, 1997K971075PRIMED PRIME-PLUS COTTON GAUZE SPONGES
Primeline Medical Products, Inc., CA
EFQ
May 8, 1997K970457DUKAL ABD COMBINE PAD
Dukal Corp.
EFQ
May 8, 1997K970455DUKAL NON ADHERENT DRESSING
Dukal Corp.
EFQ
Mar 20, 1997K970020SIMAR, INC. SURGICAL DRESSING
Simar, Inc.
EFQ
Nov 29, 1996K963724GAUZE SPONGE, NON X-RAY DETECTABLE
Grand Medical Products
EFQ
Nov 25, 1996K960615GAUZE COMPRESS
Certified Safety Mfg., Inc.
EFQ
Oct 30, 1996K963188DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
Codi International BV, NL
EFQ
Oct 11, 1996K962972SURGICADE GAUZE SPONGE
Accunex Canada,Inc.
EFQ
Sep 6, 1996K963134DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
Igenics, Inc.
EFQ
Aug 19, 1996K962227PRO-FECT STERILE GAUZE SPONGES
Network Trading Corp. Dba Grand Intl.
EFQ
Jul 29, 1996K961773PROTEC STERILE GAUZE SPONGE
Derivadas Degasa S.A. DE C.V.
EFQ
Jul 16, 1996K961775PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
Smith & Nephew United, Inc.
EFQ
Jun 28, 1996K962234STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416)
Howard Medical Co.
EFQ
Jun 6, 1996K961061CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)
Codi International BV
EFQ
May 28, 1996K961581EMERALD STERILE GAUZE SPONGE
Emerald Medical, Inc.
EFQ
Apr 4, 1996K960523NHMC DRESSING TRAY
National Healthcare Mfg. Corp., CA
EFQ
Apr 1, 1996K960388DYNAREX NON-WOVEN SPONGE
Dynarex Corp.
EFQ
Mar 25, 1996K960093PROTEC ROLL GAUZE
Derivadas Degasa S.A. DE C.V.
EFQ
Feb 5, 1996K955527GENERAL USE SYNTHETIC SPONGE (STERILE)
Igenics, Inc.
EFQ
Feb 5, 1996K955165SYNTHETIC SPONGE
Igenics, Inc.
EFQ
Dec 19, 1995K955321PROTEC GAUZE SPONGE
Derivados DE Gasa, S.A. DE C.V.
EFQ
Nov 6, 1995K953914KENTEX
Kentron Health Care, Inc.
EFQ
Sep 14, 1995K953810FLUFF GAUZE BANDAGE, STERILE & NON-STERILE
K. W. Griffen Co.
EFQ
Sep 12, 1995K953072MEROCEL VAGINAL PACK
Merocel Corp.
EFQ
Aug 28, 1995K953501ADI STERILE GAUZE SPONGES
Asia Dynamics, Inc.
EFQ
Jun 22, 1995K950906LESINSKI SURGICAL EAR DRESSING
Microtek Medical, Inc.
EFQ
Jun 19, 1995K950258HEMO-BARRIER TOURNIQUET
Hemo-Barrier Technologies, Inc.
EFQ
May 9, 1995K951660DYNAREX GAUZE SPONGE
Dynarex Corp.
EFQ
Apr 17, 1995K950404LOCKETT MEDICAL CORP. GAUZE
Lockett Medical Corp.
EFQ
Apr 14, 1995K951418LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILE
Lorons International Corp.
EFQ
Apr 14, 1995K950462GAUZE, NONABSORABLE, NON-MEDICATED (INTERNAL SPONGE)
Spring Intl., Inc.
EFQ
Mar 22, 1995K9450042, 3 & 4 BANDADGE COMPRESS
Certified Safety Mfg., Inc.
EFQ

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