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.

Dressing, Wound, Drug

FDA product code FRO · 659 cleared devices

Class U Unknown

Review panel: SU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-03-28 – 2026-09-22

FRO 1995-03-01

DUMEX WET DRESSINGS

Applicant Dumex Medical Surgical Products, Ltd.

K number K950132

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FRO 1995-02-14

KIT PAK WET SALINE DRESSING

Applicant Kit Pak, Inc.

K number K942959

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FRO 1995-02-07

PREPPIES SKIN BARRIER WIPE

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K945675

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FRO 1995-01-24

STERIL-DERM-PLUS TRANSPARENT DRESSING

Applicant Biointerface Technologies, Inc.

K number K931766

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FRO 1994-09-08

INNOVATIVE TECHNOLOGIES HYDROCOLLOID WOUND DRESSINGS

Applicant Innovative Technologies , Ltd.

K number K941688

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FRO 1994-05-20

DERMAASSIST HYDROCOLLOID DRESSING

Applicant Wilshire Medical Products

K number K941149

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FRO 1994-04-14

DERMASSIST(TM) XEROFORM PETROLATUM DRESSING

Applicant Wilshire Medical Products

K number K941005

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FRO 1994-03-31

WET DRESSING

Applicant Medtrax Industries, Inc.

K number K940691

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FRO 1994-03-30

XEROFORM PETROLATUM DRESSING

Applicant Medtrax Industries, Inc.

K number K940694

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FRO 1994-03-30

PETROLATUM DRESSING

Applicant Medtrax Industries, Inc.

K number K940693

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FRO 1994-03-22

M-K WET SALINE DRESSING

Applicant Mason-Keller Corp.

K number K940110

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FRO 1994-03-03

DERMASSIST WET DRESSING, WATER

Applicant Wilshire Medical Products

K number K940076

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FRO 1994-03-03

DERMASSIST WET DRESSING, SALINE

Applicant Wilshire Medical Products

K number K940044

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FRO 1994-03-03

DERMASSIST OIL EMULSION NON-ADHERING WOUND DRESSING

Applicant Wilshire Medical Products

K number K936234

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FRO 1994-03-03

DERMASSIST PETROLATUM GAUZE,USP

Applicant Wilshire Medical Products

K number K936230

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FRO 1994-02-25

IODOFORM PACKAGING STRIP

Applicant Albahealth Products

K number K940339

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FRO 1993-12-10

SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)

Applicant Polymedica Industries, Inc.

K number K932676

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FRO 1993-11-24

SALINE WET DRESSING- STERILE

Applicant Trinity Laboratories, Inc.

K number K934258

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FRO 1993-11-08

IMC SALINE WET DRESSING

Applicant Inman Medical Corp.

K number K933774

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FRO 1993-10-28

SURE-ADAPT NON-ADHERING DRESSING

Applicant Medtrax Industries, Inc.

K number K933966

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FRO 1993-07-13

GERITREX STERILE SALINE WET DRESSING

Applicant Geritrex Corp.

K number K931510

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FRO 1993-05-27

DERMAGRAN WOUND DRESSING

Applicant Derma Sciences, Inc.

K number K924754

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FRO 1993-05-12

MEDTRAX PACKING STRIP

Applicant Medtrax Industries, Inc.

K number K926207

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FRO 1992-11-23

SPARTA WET DRESSING, SODIUM CHLORIDE

Applicant Sparta Surgical Corp.

K number K922729

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FRO 1992-11-23

INMAN MEDICAL OIL EMULSION DRESSING

Applicant Inman Medical Corp.

K number K921290

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FRO 1992-11-10

INMAN MEDICAL PETROLATUM DRESSING

Applicant Inman Medical Corp.

K number K921289

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FRO 1992-06-16

PROLONGED OCCLUSION DRESSING I

Applicant Ferndal Laboratories

K number K920875

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FRO 1992-06-16

PROLONGED OCCLUSION DRESSING II

Applicant Ferndal Laboratories

K number K920874

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FRO 1992-02-21

SILVER FOAM WOUND DRESSING

Applicant Vitaphore Corp.

K number K914579

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FRO 1992-01-31

DERMAPROOF

Applicant Pharmalett Medical Care, Holland B.V.

K number K914840

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FRO 1991-09-25

INCARE HOT/ICE ABSORBENT INTERFACE

Applicant Hollister, Inc.

K number K913035

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FRO 1991-09-06

GAUZE PACKING, SURGICAL STERILE AND NON-STERILE

Applicant Keilei Intl., Inc.

K number K913575

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FRO 1991-08-21

ALGINATE FIBER

Applicant Shepherd Medical Corp.

K number K905040

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FRO 1991-04-01

NORMLGEL PROTECTIVE WOUND GEL

Applicant Scott Health Care

K number K905438

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FRO 1991-02-19

ALGODERM ALGINATE WOUND DRESSING

Applicant Les Laboratorires Brothier, S.A.

K number K905314

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FRO 1991-01-25

DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K904852

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FRO 1990-06-07

CARRINGTON WOUND DRESSING

Applicant Carrington Laboratories, Inc.

K number K902345

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FRO 1990-06-06

WOUND TREATMENT KIT

Applicant Orion Life Systems, Inc.

K number K901109

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FRO 1990-03-27

MESALT STERILE DRESSING

Applicant Scott Health Care

K number K897142

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FRO 1990-03-19

WATER JEL STERILE GEL-SOAKED BURN DRESSING

Applicant Trilling Medical Technologies, Inc.

K number K900516

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FRO 1990-01-19

WOUND DRESSING

Applicant Viaderm Pharmaceuticals, Inc.

K number K896702

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FRO 1990-01-03

SILASTIC SOFT SHEETING

Applicant Dow Corning Wright

K number K894226

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FRO 1989-11-30

CARRINGTON DERMAL WOUND GEL

Applicant Carrington Laboratories, Inc.

K number K894541

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FRO 1989-10-24

GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT

Applicant Premium Plastics, Inc.

K number K890107

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FRO 1989-09-28

BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM

Applicant Johnson & Johnson International

K number K895207

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FRO 1989-09-28

EXUSORB(TM) GRANULES

Applicant Controlled Therapeutics Corp.

K number K894996

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FRO 1989-09-26

ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVER

Applicant Johnson & Johnson Patient Care, Inc.

K number K892851

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FRO 1989-08-25

DAMOR CREAM SATURATED DRESSING

Applicant Damor America, Inc.

K number K891097

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FRO 1989-08-23

2ND SKIN NON-STICK MOIST BURN PADS

Applicant Spenco Medical Corp.

K number K894898

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FRO 1989-08-23

KALTOCARB WOUND DRESSING

Applicant Calgon Vestal Div.

K number K894347

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FRO 1989-08-09

INTRASITE* GEL (3) YEAR SHELF LIFE

Applicant Smith & Nephew United, Inc.

K number K891870

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FRO 1989-07-25

PHYNE-VU

Applicant Medical Resources, Ltd.

K number K885096

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FRO 1989-07-14

KALTOSTAT WOUND PACKING

Applicant Calgon Vestal Div.

K number K892868

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FRO 1989-06-23

KALTOSTAT(TM) WOUND DRESSING

Applicant Calgon Vestal Div.

K number K892364

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FRO 1989-06-13

CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS

Applicant Beiersdorf, Inc.

K number K885279

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FRO 1989-06-09

TEGASORB(TM) ULCER DRESSING, #90-XXX

Applicant 3M Company

K number K891288

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FRO 1989-06-05

WATER JEL STERILE GEL-SOAKED BURN DRESSING

Applicant Pfizer, Inc.

K number K892360

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FRO 1989-05-24

WEDGE PRESSURE DRESSING

Applicant Durden Enterprises, Inc.

K number K891189

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FRO 1989-05-24

VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS

Applicant Elwyn, Inc.

K number K891133

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FRO 1989-05-05

ACTIDERM*-OPAQUE

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K892232

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FRO 1989-03-23

NU-DERM HYDROCOLLOID DRESSING

Applicant Johnson & Johnson Patient Care, Inc.

K number K890545

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FRO 1989-03-22

WATER JEL STERILE GEL-SOAKED BURN DRESSING

Applicant Pfizer Pharmaceuticals

K number K885321

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FRO 1989-03-03

PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH

Applicant Baxter Healthcare Corp

K number K885045

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FRO 1989-02-22

POLYGLUCOSE POWDER

Applicant Anthony N Silvetti, M.D., S.C.

K number K884422

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FRO 1989-01-05

UNNA BOOT DRESSING W/CALAMINE

Applicant Graham-Field, Inc.

K number K883224

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FRO 1988-12-27

PHARMASEAL STERILE WOUND CARE DRESSING

Applicant Baxter Healthcare Corp

K number K884397

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FRO 1988-10-05

SKINCOTE

Applicant Dynarex Corp.

K number K882567

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FRO 1988-09-22

COMPEED ATHLETIC DRESSING

Applicant Coloplast A/S

K number K883588

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FRO 1988-07-19

SORBSAN TOPICAL WOUND DRESSING

Applicant E.G. Dick & Assoc.

K number K881854

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FRO 1988-06-22

HYDROCOLLOID DRESSING FOR PSORIASIS

Applicant Hollister, Inc.

K number K881039

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FRO 1988-04-28

DUODERM(R) HYDROACTIVE(R) PASTE

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K881302

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FRO 1988-04-01

NON ADHERENT PAD

Applicant Cederroth, Inc. USA

K number K880788

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FRO 1988-04-01

TEGASORB ULCER DRESSING #90-XXX

Applicant 3M Company

K number K872298

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FRO 1988-03-23

FERRIS HYDROPHILIC DRESSING

Applicant Ferris Mfg. Corp.

K number K880330

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FRO 1988-03-21

AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.

Applicant Smith & Nephew, Inc.

K number K881048

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FRO 1988-02-26

REPLICARE

Applicant United Medical

K number K880299

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FRO 1988-02-22

DERMATOLOGICAL PATCH

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K872926

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FRO 1988-01-22

WATER-JEL(R) BURN DRESSING

Applicant Trilling Resources, Ltd.

K number K864841

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FRO 1987-11-23

S3 MEDICATED GAUZE

Applicant Surgical Specialties, Inc.

K number K874219

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FRO 1987-11-17

COMFEEL ULCUS ULCER CARE SYSTEM

Applicant Coloplast A/S

K number K873669

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FRO 1987-11-09

D.R.P. THREE STEP WOUND DRESSING

Applicant Bioderm, Inc.

K number K871327

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FRO 1987-08-06

FERRIS TRANSPARENT WOUND DRESSING W/HYDROCOLLOID

Applicant Ferris Mfg. Corp.

K number K871675

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FRO 1987-07-29

INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING

Applicant Smith & Nephew, Inc.

K number K872624

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FRO 1987-07-24

CUTINOVA(R) PLUS FOAM GELFILM

Applicant Beiersdorf, Inc.

K number K864913

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FRO 1987-06-26

ELASTO-GEL OCCLUSIVE DRESSING

Applicant Southwest Technologies, Inc.

K number K872165

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FRO 1987-06-26

AMERICAN PHARMASEAL WOUND DRESSING

Applicant American Pharmaseal Div. Ahsc

K number K871770

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FRO 1987-05-29

MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSING

Applicant Hercon Laboratories Corp.

K number K871255

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FRO 1987-04-13

PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG.

Applicant Steridyne Laboratories, Inc.

K number K870430

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FRO 1987-04-06

HERCON ANTI. TRANS. DRESSING AS A WOUND DRESSING

Applicant Hercon Laboratories Corp.

K number K870743

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FRO 1987-02-26

GAUZE, ABSORBENT, IODOFORM IMPREGNATED

Applicant Steridyne Laboratories, Inc.

K number K870431

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FRO 1987-02-26

RUBYCELL(TM) SYNTHETIC ISLAND DRESSING

Applicant Bioderm, Inc.

K number K870352

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FRO 1987-02-06

COMPRESS AND BANDAGE, VARIOUS SIZES

Applicant Fraass Survival Systems, Inc.

K number K870241

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FRO 1987-02-06

BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES

Applicant Fraass Survival Systems, Inc.

K number K870184

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FRO 1987-02-04

FERRIS DYNADERM PLUS

Applicant Ferris Mfg. Corp.

K number K865089

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FRO 1986-12-01

VISCOPASTE ZINC PASTE BANDAGE

Applicant Smith & Nephew, Inc.

K number K863930

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FRO 1986-11-21

LYOFOAM C ODOR-ABSORBING DRESSING

Applicant Acme United Corp.

K number K864084

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FRO 1986-11-17

UNITED WOUND COVERING, PACKAGE OF 5

Applicant United Medical

K number K863389

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FRO 1986-11-14

CHESEBROUGH POND'S HYDROCOLLOID DRESSING

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

K number K862803

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FRO 1986-09-30

HYDROCOLLOID DRESSINGS - STERILE

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K863390

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FRO 1986-08-04

HOLLISTER WOUND CARE BARRIER

Applicant Hollister, Inc.

K number K862572

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