Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Gauze/Sponge, Internal

FDA product code EFQ · 271 cleared devices

Class U Unknown

Review panel: SU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-07-15 – 1999-08-12

EFQ 1994-01-14

BURN COMPRESS

Applicant Mcneil Healthcare, Inc.

K number K935932

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EFQ 1994-01-14

NON-WOVEN SPONGE

Applicant Mcneil Healthcare, Inc.

K number K935931

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EFQ 1994-01-13

SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE

Applicant Mcneil Healthcare, Inc.

K number K935942

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EFQ 1993-12-22

DYNAREX GAUZE SPONGE OR PADS

Applicant Dynarex Corp.

K number K933308

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EFQ 1993-12-13

XYZ PADS

Applicant Aso Corp.

K number K933159

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EFQ 1992-09-18

NU-BREDE PACKING AND DEBRIDEMENT SPONGE

Applicant Johnson & Johnson Medical, Inc.

K number K921983

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EFQ 1992-08-10

INTESTINAL SPONGES

Applicant Surgic Aid, Inc.

K number K923041

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EFQ 1992-08-10

STERILE AND NON-STERILE GAUZE SPONGES

Applicant Team Mfg., Inc.

K number K922055

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EFQ 1991-12-31

PTI INTRA-ART (TM) PICK-UP WICKS

Applicant Pioneering Technologies, Inc.

K number K905068

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EFQ 1991-09-10

EYE PAD

Applicant Cal West Trading Co.

K number K912955

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EFQ 1991-04-01

GAUZE SPONGES ABSORBENT GAUZE ROLLS

Applicant Liaoning-Usa Corp.

K number K910623

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EFQ 1991-03-06

GAUZE SPONGES, INTERNAL AND EXTERNAL

Applicant American Healthcare Corp.

K number K905136

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EFQ 1990-08-01

MEDI-SURE, MEDI-SORB

Applicant Gulf Coast Medical, Inc.

K number K897180

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EFQ 1989-12-27

LAP SPONGE

Applicant Westmark, Sterile Packing Systems, Inc. (Sps)

K number K896801

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EFQ 1989-12-27

SERENE WRAP

Applicant Byron Medical

K number K895865

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EFQ 1989-12-13

CURITY(R) DISPOSABLE LAPAROTOMY SPONGES

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K896490

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EFQ 1989-10-23

GAUZE SPONGE

Applicant Keilei Intl., Inc.

K number K895086

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EFQ 1989-09-15

COTOLIN DRAIN SPONGE AND DRESSING SPONGE

Applicant James River Corp.

K number K894505

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EFQ 1989-07-14

4 X 4 STERILE GAUZE SPONGE TRAY

Applicant Mumtaz I. Malik

K number K893902

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EFQ 1989-04-17

NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE

Applicant Smith & Nephew United, Inc.

K number K891460

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EFQ 1989-03-14

STERILE LAPAROTOMY SPONGES

Applicant Cypress Medical Products, Ltd.

K number K890770

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EFQ 1989-03-10

NON-STERILE, BULK GAUZE SPONGES

Applicant Cypress Medical Products, Ltd.

K number K890727

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EFQ 1989-02-10

ABSORBENT GAUZE ROLL

Applicant Smith & Nephew, Inc.

K number K885143

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EFQ 1989-01-24

GAUZE SWABS, NON-STERILE

Applicant Smith & Nephew, Inc.

K number K885142

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EFQ 1988-12-22

GAUZE SPONGE

Applicant Medical Action Industries, Inc.

K number K884826

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EFQ 1988-08-26

PRO-FECT LAPAROTOMY SPONGES

Applicant Network Trading Corp.

K number K882021

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EFQ 1988-08-03

STICK SPONGE

Applicant Bioseal

K number K882712

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EFQ 1988-08-03

GAUZE SPONGE 12PLY

Applicant Bioseal

K number K882711

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EFQ 1988-08-03

INTESTINAL SPONGES

Applicant Bioseal

K number K882710

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EFQ 1988-07-18

TAPE STRUNG TONSIL SPONGE

Applicant Ormed Mfg., Inc.

K number K882530

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EFQ 1988-07-18

BUTCHER STRUNG TONSIL SPONGE

Applicant Ormed Mfg., Inc.

K number K882529

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EFQ 1988-07-18

CYLINDRICAL SPONGE

Applicant Ormed Mfg., Inc.

K number K882528

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EFQ 1988-07-18

GAUZE SPONGE

Applicant Ormed Mfg., Inc.

K number K882527

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EFQ 1988-04-28

GAUZE AND LAP SPONGES -STERILE & NON-STERILE

Applicant A Plus International, Inc.

K number K881395

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EFQ 1988-04-12

INVESTIGATION KIT, SEXUAL ASSAULT DETERMINATION

Applicant Dresser Argus, Inc.

K number K880208

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EFQ 1988-03-28

JOHNSON & JOHNSON FLUFF SPONGE

Applicant Johnson & Johnson Professionals, Inc.

K number K881222

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EFQ 1988-03-17

BLUNT SPONGE

Applicant Ormed Mfg., Inc.

K number K880911

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EFQ 1988-03-17

ROUND STICK SPONGES

Applicant Ormed Mfg., Inc.

K number K880910

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EFQ 1988-03-17

TRACHEOTOMY SPONGES

Applicant Ormed Mfg., Inc.

K number K880909

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EFQ 1988-03-17

TRIANGLE SPONGE

Applicant Ormed Mfg., Inc.

K number K880907

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EFQ 1988-03-17

STRUNG ABSORBENT BALLS

Applicant Ormed Mfg., Inc.

K number K880854

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EFQ 1988-03-17

CHERRY SPONGE

Applicant Ormed Mfg., Inc.

K number K880853

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EFQ 1988-03-17

ROSEBUD DISSECTORS

Applicant Ormed Mfg., Inc.

K number K880852

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EFQ 1988-03-17

FLAT STICK SPONGE

Applicant Ormed Mfg., Inc.

K number K880851

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EFQ 1988-01-22

ENVINET(TM)

Applicant Marion Laboratories, Inc.

K number K874551

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EFQ 1988-01-14

PHARMANET (TM)

Applicant Pharmacia, Inc.

K number K872572

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EFQ 1987-12-14

GUAZE SPONGES

Applicant Interpro Intl., Inc.

K number K874067

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EFQ 1987-11-04

LAPAROTOMY SPONGES

Applicant Interpro Intl., Inc.

K number K874065

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EFQ 1987-10-09

PLAIN DRY GAUZE

Applicant Absorbent Cotton Co., Inc.

K number K873523

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EFQ 1987-10-05

EAR AND EYE SPONGES

Applicant Ormed Mfg., Inc.

K number K873831

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EFQ 1987-09-04

AQUATULLE FINE MESH NON-ADHERING DRESSING

Applicant Smith & Nephew, Inc.

K number K872759

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EFQ 1987-08-04

CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8

Applicant American Silk Sutures, Inc.

K number K872808

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EFQ 1987-08-04

STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG

Applicant American Silk Sutures, Inc.

K number K872806

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EFQ 1987-06-16

FRASTEC DRY GAUZE BANDAGE

Applicant Fraass Survival Systems, Inc.

K number K871917

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EFQ 1987-06-16

FRASTEC DRY BURN DRESSING

Applicant Fraass Survival Systems, Inc.

K number K871916

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EFQ 1987-05-06

BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52

Applicant Fraass Survival Systems, Inc.

K number K871438

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EFQ 1987-03-31

18X36,36X36,18X72,24X72 GAUZE COMPRESS

Applicant Advantage Credit Services, Inc.

K number K871005

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EFQ 1987-03-31

1X5YD,2X6YD,3X5YD,4X6YD,1/2/3X10YD GAUZE

Applicant Advantage Credit Services, Inc.

K number K871002

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EFQ 1987-03-31

2, 3 AND 4 BANDAGE COMPRESS

Applicant Advantage Credit Services, Inc.

K number K870993

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EFQ 1987-02-24

WHITE PLUME GAUZE SPONGE

Applicant China National Medicines & Health Prod. I/E Corp.

K number K870314

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EFQ 1987-02-24

WHITE PLUME ABSORBENT GAUZE

Applicant China National Medicines & Health Prod. I/E Corp.

K number K870308

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EFQ 1987-01-20

AIMED GAUZE SPONGE

Applicant Kor-Medical Industries, Ltd.

K number K865097

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EFQ 1987-01-20

ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES

Applicant Kor-Medical Industries, Ltd.

K number K865095

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EFQ 1986-12-04

ZENEX MEDICAL, INC. GAUZE SPONGES

Applicant Zenex Medical, Inc.

K number K864298

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EFQ 1986-11-05

SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES

Applicant Fraass Survival Systems, Inc.

K number K864175

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EFQ 1986-10-24

GAUZE, ABSORBENT, STERILE, COMPRESSED

Applicant Fraass Survival Systems, Inc.

K number K863932

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EFQ 1986-10-24

GAUZE, NONABSORBABLE, NON-MEDICATED (INTERNAL)

Applicant Med-Tex, Inc.

K number K863870

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EFQ 1986-10-24

2X2 SPONGES, NON-STERILE, COTTON FILLED

Applicant The Medical Group, Inc.

K number K863761

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EFQ 1986-10-24

2X2 SPONGES, NON-STERILE

Applicant The Medical Group, Inc.

K number K863760

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EFQ 1986-10-14

DRESSING, FIRST AID, FIELD, VARIOUS SIZES

Applicant Fraass Survival Systems, Inc.

K number K863850

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EFQ 1986-10-14

SPONGES STERILE TWIN PAKT AND SINGLES

Applicant Hermitage Hospital Products, Inc.

K number K863737

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EFQ 1986-10-14

BANDAGE, GAUZE, SIX-PLY, VARIOUS SIZES

Applicant Fraass Survival Systems, Inc.

K number K863714

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EFQ 1986-10-14

BANDAGE, GAUZE, TWO-PLY, VARIOUS SIZES

Applicant Fraass Survival Systems, Inc.

K number K863713

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EFQ 1986-06-19

STERILE LAPAROTOMY GAUZE SPONGE

Applicant Anago, Inc.

K number K862126

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EFQ 1986-05-06

S1 ORAL PACKING

Applicant Surgical Specialties, Inc.

K number K861446

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EFQ 1986-05-06

S1 CAVITY PACKING

Applicant Surgical Specialties, Inc.

K number K861445

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EFQ 1986-05-06

S1 NASAL PACKING

Applicant Surgical Specialties, Inc.

K number K861444

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EFQ 1986-05-06

S1 VAGINAL PACKING

Applicant Surgical Specialties, Inc.

K number K861443

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EFQ 1986-05-02

ACCUPAC CUSTOM PACK KERLIX SQUARES

Applicant Geneva Laboratories, Inc.

K number K861308

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EFQ 1986-04-17

GAUZE SPONGES USP TYPE VII

Applicant Selomas, Inc.

K number K861215

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EFQ 1986-04-15

ALBA HEALTH CARE PLAIN PACKING STRIP

Applicant Alba Health Care

K number K861154

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EFQ 1985-11-22

FALKON STRETCH

Applicant G.B.F. Industries, Inc.

K number K854432

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EFQ 1985-07-29

NON-ADHERENT PAD

Applicant American White Cross, Inc.

K number K852412

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EFQ 1985-07-26

4 X 4' GAUZE PAD

Applicant Cornelia Damsky, Inc.

K number K852857

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EFQ 1985-06-26

STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE

Applicant Ormed Mfg., Inc.

K number K852202

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EFQ 1985-06-18

NON-STERILE GAUZE ROLLER BANDAGES

Applicant Leonard Joseph Co.

K number K852265

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EFQ 1985-04-01

GAUZE SPONGE 4X4X12 PLY

Applicant Applied Medical

K number K844726

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EFQ 1985-04-01

GAUZE ASORBABLE

Applicant Medicon, Inc.

K number K844702

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EFQ 1985-04-01

APPLIED GAUZE SPONGE 2X2X12

Applicant Applied Medical

K number K844677

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EFQ 1985-04-01

APPLIED GAUZE SPONGE 4X4X8

Applicant Applied Medical

K number K844676

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EFQ 1985-04-01

APPLIED GAUZE SPONGE 3X3X12

Applicant Applied Medical

K number K844675

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EFQ 1985-04-01

APPLIED GAUZE SPONGE 2X2X8 PLY

Applicant Applied Medical

K number K844674

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EFQ 1985-04-01

APPLIED GAUZE SPONGE 4X4X16 PLY

Applicant Applied Medical

K number K844673

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EFQ 1985-03-05

ABSORBABLE GAUZE PRODUCTS

Applicant Medicon, Inc.

K number K844573

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EFQ 1985-02-21

PANAMEDIC GAUZE SPONGES

Applicant General Electric Trading Co.

K number K850093

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EFQ 1984-12-19

WET PACK

Applicant E.M. Adams

K number K843783

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EFQ 1984-12-13

DRY TRAY

Applicant E.M. Adams

K number K843782

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EFQ 1984-01-27

PAREMA K BAND NON-STERILE

Applicant Mark One Healthcare Products

K number K833867

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EFQ 1983-09-26

VILENE COTTON GAUZE II

Applicant Hall-Tech

K number K831917

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EFQ 1983-08-12

GAUZE SPONGE NON-STERILE

Applicant Sudreca Surgical Dressings, Inc.

K number K832174

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