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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 1983-08-12

GAUZE SPONGE STERILE

Applicant Sudreca Surgical Dressings, Inc.

K number K832173

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EFQ 1983-07-26

GAUZE CONVERSION CLASS I-NON-STERILE

Applicant Winn Hirsch & Assoc.

K number K832214

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EFQ 1983-07-26

GAUZE CONVERSION CLASS II STERILE

Applicant Winn Hirsch & Assoc.

K number K832213

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EFQ 1983-06-29

SUTURE KITS STERILIZED W/GAMA RADIATION

Applicant South Mountain Medical

K number K831806

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EFQ 1983-06-08

GAUZE SPONGE STERILE SPONGE

Applicant Den Med, Inc.

K number K831183

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EFQ 1983-06-08

GAUZE SPONGE-NON-STERILE SPONGE

Applicant Den Med, Inc.

K number K831182

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EFQ 1983-06-08

FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN

Applicant Ritmed, Inc.

K number K830268

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EFQ 1983-06-08

FLORET SPECIAL GAUZE SPONGES

Applicant Ritmed, Inc.

K number K830267

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EFQ 1983-06-08

FLORET KITTNER OR K DISSECTOR

Applicant Ritmed, Inc.

K number K830266

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EFQ 1983-06-08

FLORET STRUNG GAUZE SPONGES

Applicant Ritmed, Inc.

K number K830261

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EFQ 1983-06-03

FLORET TONSIL & ADENOID SPONGES

Applicant Ritmed, Inc.

K number K830264

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EFQ 1983-06-02

LAPET & LAPWALL LAPAROTOMY SPONGES

Applicant Ritmed, Inc.

K number K830271

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EFQ 1983-06-02

FLORET NEURO SPONGE

Applicant Ritmed, Inc.

K number K830269

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EFQ 1983-03-29

FLORET GAUZE PACKING

Applicant Ritmed, Inc.

K number K830278

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EFQ 1983-03-29

FLORET DRAIN/TRACHEOTOMY SPONGE

Applicant Ritmed, Inc.

K number K830265

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EFQ 1983-03-08

FLORET PEANUT SPONGE/STICK & GAUZE PREP

Applicant Ritmed, Inc.

K number K830274

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EFQ 1982-12-09

DOSOMETRIC RELEASE STERILIZATION

Applicant Stan-Pak Ent.

K number K823058

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EFQ 1982-12-03

SURE SNIP

Applicant South Mountain Medical

K number K823485

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EFQ 1982-08-27

NU-GAUZE SPONGE

Applicant Johnson & Johnson Professionals, Inc.

K number K821150

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EFQ 1982-07-22

RAPIDO-LASTIC IN STERILE FORM

Applicant Conco Medical Co.

K number K821701

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EFQ 1982-03-05

OR SPECIALTIES VAGINAL PACK

Applicant Howard Medical Co.

K number K820195

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EFQ 1982-02-12

GUAZE SPONGES, PLAIN

Applicant Stan-Pak Ent.

K number K820107

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EFQ 1982-02-12

X-RAY GUAZE SPONGES

Applicant Stan-Pak Ent.

K number K820106

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EFQ 1981-12-29

CONVERTORS STERILE DISP. LAP SPONGE II

Applicant American Convertors Div., American Pharmaseal

K number K813296

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EFQ 1981-11-06

SOFTCARE BARRIER WET DRESSING

Applicant The Kendal Co.

K number K812736

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EFQ 1981-11-02

GAUZE SPONGES

Applicant Worldwide Surgical Gauze

K number K812572

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EFQ 1981-10-16

DRESSING CHANGE TRAYS & STERILE SPONGES

Applicant O.R. Specialties, Inc.

K number K811951

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EFQ 1981-05-27

DENTMED V-PACKS

Applicant Univ. of Bristol Dental School

K number K810801

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EFQ 1981-02-13

OPTIPORE SCRUB SPONGE

Applicant Bio Syntec

K number K810200

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EFQ 1981-01-15

GAUZE SPONGES

Applicant Worldwide Surgical Gauze

K number K803172

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EFQ 1980-12-11

GAUZE SPONGES

Applicant Abco Dealers, Inc.

K number K802863

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EFQ 1980-12-11

GAUZE PADS STERILE SINGLES

Applicant Abco Dealers, Inc.

K number K802862

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EFQ 1980-12-11

COMBINATION PADS STERILE SINGLES

Applicant Abco Dealers, Inc.

K number K802861

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EFQ 1980-12-11

POST OP. SPONGES STERILE

Applicant Abco Dealers, Inc.

K number K802860

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EFQ 1980-11-12

SPONGE SURGICAL GUAZE RADIOPAQUE

Applicant Barnhardt Mfg. Co.

K number K802504

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EFQ 1980-11-12

MAJOR DRESSING TRAY-MILFORD HOSP.

Applicant American Medical Disposable, Inc.

K number K802388

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EFQ 1980-11-12

MINOR DRESSING TRAY-MILFORD HOSP.

Applicant American Medical Disposable, Inc.

K number K802387

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EFQ 1980-11-12

CUSTOM DRESSING TRAY/CARDINAL CUSHING

Applicant American Medical Disposable, Inc.

K number K802383

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EFQ 1980-09-16

STERILE GUAZE SWABS CAT.#301-420

Applicant Pollak (Intl.), Ltd.

K number K802022

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EFQ 1980-09-16

GUAZE SWABS CAT.#251-300 (SIZE & PLY)

Applicant Pollak (Intl.), Ltd.

K number K802010

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EFQ 1980-09-16

ABSORBENT PAD CAT.#729, 732, 730, 731

Applicant Pollak (Intl.), Ltd.

K number K802005

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EFQ 1980-09-16

GUAZE BALLS CAT.#601-720

Applicant Pollak (Intl.), Ltd.

K number K801999

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EFQ 1980-02-05

STORZ SUPER SORB MICRO EYE SPONGE

Applicant Storz Instrument Co.

K number K800082

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EFQ 1980-01-17

NON ADHERANT NEUROLOGICAL SPONGES

Applicant American Medical Disposable, Inc.

K number K800021

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EFQ 1980-01-17

NON ADHERANT WOUND BANDAGES

Applicant American Medical Disposable, Inc.

K number K800020

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EFQ 1980-01-11

STERILIZATION PROCESS/VAGINAL SPONGE

Applicant Procter & Gamble Mfg. Co.

K number K792628

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EFQ 1980-01-09

TRACHEOTOMY SPONGE, NON-WOVEN DELNET

Applicant American Medical Disposable, Inc.

K number K792618

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EFQ 1980-01-09

TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER

Applicant American Medical Disposable, Inc.

K number K792617

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EFQ 1980-01-09

TRACHEOTOMY SPONGE, NON-ADHERENT W/HDPE

Applicant American Medical Disposable, Inc.

K number K792616

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EFQ 1980-01-09

CELLULOSE TRACHE SPONGE

Applicant American Medical Disposable, Inc.

K number K792615

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EFQ 1980-01-09

TRACHOETOMY SPONGE, NON-ADHERENT CELL

Applicant American Medical Disposable, Inc.

K number K792614

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EFQ 1980-01-09

TRACHEOTOMY SPONGE, NON-ADHERENT

Applicant American Medical Disposable, Inc.

K number K792613

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EFQ 1980-01-09

TRACHEOTOMY SPONGE, W/NON-WOVEN NYLON

Applicant American Medical Disposable, Inc.

K number K792612

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EFQ 1979-12-27

VAGINAL PACKING

Applicant American Medical Disposable, Inc.

K number K792431

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EFQ 1979-11-13

LAP SPONGES

Applicant Carwild Corp.

K number K791872

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EFQ 1979-11-05

NEUROLOGICAL SPONGES (PATTIES)

Applicant Carwild Corp.

K number K791871

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EFQ 1979-10-17

CATHETER CARE KIT REORDER 7940&7941

Applicant Ascep, Inc.

K number K791888

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EFQ 1979-07-30

STERAID SURGICAL DRESSING

Applicant Corda Intl. Holdings, Inc.

K number K790631

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EFQ 1979-03-26

SURGICAL EYE SPONGE

Applicant Medtech Intl., Inc.

K number K790467

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EFQ 1978-12-07

BURN PAD, DRY, STERILE

Applicant Chesebrough-Pond'S U.S.A. Co.

K number K781985

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EFQ 1978-10-03

SPECIALTY SPONGES

Applicant Ipco Corp.

K number K781420

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EFQ 1978-08-17

STERILE WET DRESSING PACK

Applicant W.G. Whitney Corp.

K number K781322

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EFQ 1978-06-22

LAPAROTOMY SPONGE

Applicant Qualtex, Inc.

K number K780818

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EFQ 1978-06-22

LAPOROTOMY SPONGE

Applicant Abco Dealers, Inc.

K number K780806

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EFQ 1977-11-11

LAPAROTOMY SPOGNE

Applicant General Medical Co.

K number K772089

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EFQ 1977-09-06

LAPAROTOMY SPONGES

Applicant Surgilite Intl., Inc.

K number K771531

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EFQ 1977-07-11

BURN DRESSING KIT

Applicant The Owenby Co.

K number K770889

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EFQ 1977-06-15

SPONGES, LAPAROTOMY

Applicant Walpak Co.

K number K770446

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EFQ 1977-01-05

SURGEX SURGICAL SPONGE

Applicant Convertors

K number K761034

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EFQ 1976-12-29

INTERSORB LAPAROTOMY SPONGE

Applicant Chesebrough-Pond'S U.S.A. Co.

K number K761037

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EFQ 1976-07-15

SPONGE, LAPAROTOMY GAUZE

Applicant Parke-Davis Co.

K number K760113

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