Atlas FDA

EFQ

271 FDA 510(k) clearances · Product code

39 daysmedian time to decision
122 days90th percentile
271clearances measured

FDA profile

Official device name
Gauze/Sponge, Internal
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
2013: 8 · 2014: 11 · 2015: 27 · 2016: 53 · 2025: 51 · 2026: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (K991757)Furlong Industries1999-08-12
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (K991215)Symtex Healthcare Corp.1999-06-11
VITOP DRESSING (K990974)Wonder & Bioenergy Hi-Tech America, Inc.1999-06-09
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (K990584)Broadline Medical Industries1999-04-23
CROSSTEX NON-WOVEN SPONGES (K984187)Crosstex Intl.1999-02-18
GAUZE, SPONGES, CAT # 11-003 (K983016)Vitalcare Group, Inc.1999-02-12
DYNAREX TRACHEOSTOMY SPONGE (K983348)Dynarex Corp.1998-12-11
STARRYSHINE GAUZE SPONGE (K983450)T.C. Dental Products, Inc.1998-11-12
JOAN II (K982648)Celanese Acetate Co.1998-09-30
DUMEX PAK-ITS WOVEN RIBBON PACKING (K980791)Dumex Medical Surgical Products, Ltd.1998-04-29
HYDROFERA FEMORAL WICK (K974316)Hydrofera, LLC1998-02-13
BALDUR NON-STERILE COTTON SPONGES (K974347)Baldur Systems Corp.1998-02-10
KENDALL CURITY IODOFORM PACKING STRIP (K973763)Kendall Healthcare Products Co. Div.Of Tyco Health1997-12-31
INVOTEC CLEAN PAD (K973580)Invotec International, Inc.1997-12-10
PIN CARE KIT (K973299)Brown Medical Industries1997-11-26
OPPORTUNITY SUTURE REMOVAL KIT (K971095)Opportunity, Inc.1997-09-16
OPPORTUNITY INCISION AND DRAINAGE TRAY (K971088)Opportunity, Inc.1997-09-16
RAND SURGICAL SPONGE (K971178)Trans Aire1997-06-27
PRIMED PRIME-PLUS COTTON GAUZE SPONGES (K971075)Primeline Medical Products, Inc.1997-06-22
DUKAL ABD COMBINE PAD (K970457)Dukal Corp.1997-05-08
DUKAL NON ADHERENT DRESSING (K970455)Dukal Corp.1997-05-08
SIMAR, INC. SURGICAL DRESSING (K970020)Simar, Inc.1997-03-20
GAUZE SPONGE, NON X-RAY DETECTABLE (K963724)Grand Medical Products1996-11-29
GAUZE COMPRESS (K960615)Certified Safety Mfg., Inc.1996-11-25
DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) (K963188)Codi International BV1996-10-30
SURGICADE GAUZE SPONGE (K962972)Accunex Canada,Inc.1996-10-11
DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) (K963134)Igenics, Inc.1996-09-06
PRO-FECT STERILE GAUZE SPONGES (K962227)Network Trading Corp. Dba Grand Intl.1996-08-19
PROTEC STERILE GAUZE SPONGE (K961773)Derivadas Degasa S.A. DE C.V.1996-07-29
PROFORE FOUR-LAYER BANDAGE SYSTEM KIT (K961775)Smith & Nephew United, Inc.1996-07-16
STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416) (K962234)Howard Medical Co.1996-06-28
CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE) (K961061)Codi International BV1996-06-06
EMERALD STERILE GAUZE SPONGE (K961581)Emerald Medical, Inc.1996-05-28
NHMC DRESSING TRAY (K960523)National Healthcare Mfg. Corp.1996-04-04
DYNAREX NON-WOVEN SPONGE (K960388)Dynarex Corp.1996-04-01
PROTEC ROLL GAUZE (K960093)Derivadas Degasa S.A. DE C.V.1996-03-25
GENERAL USE SYNTHETIC SPONGE (STERILE) (K955527)Igenics, Inc.1996-02-05
SYNTHETIC SPONGE (K955165)Igenics, Inc.1996-02-05
PROTEC GAUZE SPONGE (K955321)Derivados DE Gasa, S.A. DE C.V.1995-12-19
KENTEX (K953914)Kentron Health Care, Inc.1995-11-06
FLUFF GAUZE BANDAGE, STERILE & NON-STERILE (K953810)K. W. Griffen Co.1995-09-14
MEROCEL VAGINAL PACK (K953072)Merocel Corp.1995-09-12
ADI STERILE GAUZE SPONGES (K953501)Asia Dynamics, Inc.1995-08-28
LESINSKI SURGICAL EAR DRESSING (K950906)Microtek Medical, Inc.1995-06-22
HEMO-BARRIER TOURNIQUET (K950258)Hemo-Barrier Technologies, Inc.1995-06-19
DYNAREX GAUZE SPONGE (K951660)Dynarex Corp.1995-05-09
LOCKETT MEDICAL CORP. GAUZE (K950404)Lockett Medical Corp.1995-04-17
GAUZE, NONABSORABLE, NON-MEDICATED (INTERNAL SPONGE) (K950462)Spring Intl., Inc.1995-04-14
LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILE (K951418)Lorons International Corp.1995-04-14
1X6YD, 2X6YD, 4X6YD ROLL BANDAGE (K945002)Certified Safety Mfg., Inc.1995-03-22
2, 3 & 4 BANDADGE COMPRESS (K945004)Certified Safety Mfg., Inc.1995-03-22
DUTEX GAUZE BANDAGE (K946326)Dumex Medical Surgical Products, Ltd.1995-01-24
LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS (K945960)Lorons International Corp.1995-01-12
DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE) (K945830)Dumex Medical Surgical Products, Ltd.1995-01-11
FLUFF GAUXZE ROLL (K945019)Clinical Resources, Inc.1994-12-23
FLUFF GAUZE SPONGE (K945020)Clinical Resources, Inc.1994-12-23
FLUFF GAUZE SPONGE (K945021)Clinical Resources, Inc.1994-12-23
ISOLYSER (K940765)Thantex Specialties, Inc.1994-12-19
OREX (K940716)Thantex Specialties, Inc.1994-12-19
CLEAN-SORB (K941099)Hospital Specialty Co.1994-09-30
GAUZE SPONGE (E.W.A. LTD./VARIOUS) (K943339)E.W.A., Ltd.1994-08-23
LORREX IV SPONGES, STERILE 2'S; LORREX DRAIN SPONGES, STERILE 2'S (K942824)Lorrex Health Products1994-08-03
LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILE (K942692)Lorons International Corp.1994-08-03
LORREX HEALTH PROD COTTON FILLED SPONGES STERILE 2'S (K943184)Lorons International Corp.1994-08-03
LORREX POST OPERATIVE SPONGES (K942691)Lorons International Corp.1994-07-19
SURGICAL SPONGE (K941649)Industries For the Blind & Visually Impaired1994-06-03
LORREX GAUZE SPONGES SPECIALTY (K942314)Lorrex Health Products1994-06-02
STERILE GAUZE PRODUCT LINE (K941455)Cush Medical Products1994-05-20
LORREX COVER SPONGES STERILE2'S AND NON-STERILE (K942070)Lorrex Health Products1994-05-19
LORREX NON-WOVEN SPONGES NON-STERILE (K942071)Lorrex Health Products1994-05-19
LORREX GAUZE PADS (K941956)Lorons International Corp.1994-05-19
SUPER/FLUFF SPONGES (K942106)Lorrex Health Products1994-05-19
LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S (K941955)Lorrex Health Products1994-05-12
ISOLYER (4X4, 12 PLY) (K940754)Thantex Specialties, Inc.1994-05-02
TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE (K940574)Kendall Healthcare Products Co. Div.Of Tyco Health1994-04-20
MEDICOM NON-WOVEN SPONGES (K935257)A.R. Medicom, Inc.1994-04-14
PLAIN GAUZE DRESSING (K940692)Medtrax Industries, Inc.1994-04-14
KITTNER DISSECTOR/PEANUT/CHERRY/STICK/TRIANGLE SPONGE/GAUZE ROSEBUD (K940904)Medical Insights, Inc.1994-04-14
NON-WOVEN SPONGE (K940901)Medical Insights, Inc.1994-03-31
X-LARGE MULTI-FUNCTION TRAUMA DRESSING (K940358)Certified Safety Mfg., Inc.1994-03-23
DUKAL NON-WOVEN GAUZE (K940440)Dukal Corp.1994-03-09
STERILE GAUZE SPONGES (K936216)Dav-Mar Medical Products, Inc.1994-03-09
VISITEC EYE PAD (K940210)Visitec Co.1994-03-07
TRAUMA PAD 5 X 9 (K940348)Certified Safety Mfg., Inc.1994-02-25
TRIANGULAR BANDAGE (K940345)Certified Safety Mfg., Inc.1994-02-25
8 X 10 NON-STICK PAD (K940344)Certified Safety Mfg., Inc.1994-02-25
EXTRA LARGE COMPRESS DRESSING (K940351)Certified Safety Mfg., Inc.1994-02-25
NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING (K935930)Mcneil Healthcare, Inc.1994-02-03
GAUZE SPONGE (K936095)Dukal Corp.1994-02-02
NON ADHERANT BURN PADS (K935934)Mcneil Healthcare, Inc.1994-01-31
PACKING SPONGE (K935911)Mcneil Healthcare, Inc.1994-01-31
GAUZE DRESSING (K935241)Chak Tak (Shen Zhen) Enterprises, Ltd.1994-01-25
GAUZE SPONGE; DRAIN SPONGE (K935940)Mcneil Healthcare, Inc.1994-01-14
GAUZE FLUFF (K935939)Mcneil Healthcare, Inc.1994-01-14
BURN COMPRESS (K935932)Mcneil Healthcare, Inc.1994-01-14
CONFORMING ROLL (K935936)Mcneil Healthcare, Inc.1994-01-14
CUSTOM BURN DRESSING (K935933)Mcneil Healthcare, Inc.1994-01-14
BURN GAUZE PADS (K935935)Mcneil Healthcare, Inc.1994-01-14
POST OP SPONGE (K935937)Mcneil Healthcare, Inc.1994-01-14
BANDAGE ROLLS, STRETCH GAUZE ROLLS, TEXTURED GAUZE ROLLS (K935938)Mcneil Healthcare, Inc.1994-01-14
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