ClearanceBrief
Product code FRO ยท Class U

Dressing, Wound, Drug

19510(k)s in 12 months (707 all time)
7recalls in 12 months (82 all time)
56recalls that name a 510(k)
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Top companies in FRO

Company510(k)sRecalls
Advanced Medical Solutions Limited192
Oculus Innovative Sciences146
Convatec, A Division of E.R. Squibb & Sons160
Huizhou Foryou Medical Devices Co., Ltd.160
Derma Sciences, Inc.120
Winner Medical Co., Ltd.120
Integra LifeSciences Corp. (NeuroSciences)011
Medline Industries, Inc.92
3M Company100
Acrymed, Inc.81
Decided510(k)Device and applicantCode
Feb 2, 2011K102945PEDIACYN ATOPIC DERMATITIS HYDROGEL
Oculus Innovative Sciences, Inc.
FRO
Feb 2, 2011K100948HYPO CLENZ WOUND WASH MODEL 100 PPM
Nevoa Life Sciences, LLC
FRO
Jan 24, 2011K100591SORBACT
Abigo Medical AB
FRO
Jan 21, 2011K103141LOW ADHERENT AFM AG DRESSINGS
Milliken Healthcare Products, LLC
FRO
Jan 5, 2011K100613BIOMED WOUND CLEANSER
Biomed Laboratories, Inc.
FRO
Dec 15, 2010K101118ACTIVON TULLE
Calidad Solutions, Inc.
FRO
Dec 10, 2010K100261PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
Tei Biosciences, Inc.
FRO
Dec 8, 2010K102659MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER
Manuka Medical Limited
FRO
Nov 3, 2010K102478OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING
Southwest Technologies, Inc.
FRO
Nov 3, 2010K101882PRONTOSAN ANTIMICROBIAL WOUND GEL
B.Braun Medical, Inc.
FRO
Oct 12, 2010K100580EXSALT WOUND DRESSING
Exciton Technologies, Inc., CA
FRO
Sep 15, 2010K100029MEPILEX BORDER AG DRESSING
Molnlycke Health Care
FRO
Aug 10, 2010K100693AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING
Medtrade Products Limited, GB
FRO
Aug 9, 2010K100918VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014
Puricore, Inc.
FRO
Jul 28, 2010K102002TALYMED
Marine Polymer Technologies
FRO
Jun 24, 2010K093159PR CREAM
Prugen IP Holdings, Inc.
FRO
Jun 24, 2010K093156PRUCLAIR NONSTEROIDAL CREAM
Prugen IP Holdings, Inc.
FRO
Jun 18, 2010K093320DRYODINE CADEXOMER-IODINE GEL
Collegium Pharmaceutical Incorporated
FRO
Jun 16, 2010K093351COLLAWOUND ART
Collamatrix, Inc., TW
FRO
Jun 11, 2010K100430URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
Laboratoires Urgo, FR
FRO
Jun 11, 2010K100429URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
Laboratoires Urgo, FR
FRO
May 20, 2010K092689MANUKAPLI WOUND DRESSING
Manuka Medical Limited
FRO
May 11, 2010K100839BARIREP
Gorbec Pharmaceutical Services, Inc.
FRO
Apr 13, 2010K093697VASHE WOUND THERAPY SOLUTION
Puricore, Inc.
FRO
Apr 8, 2010K092351POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS
Polyremedy, Inc.
FRO
Apr 8, 2010K092348POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS
Polyremedy, Inc.
FRO
Mar 8, 2010K093585MICROCYN SKIN AND WOUND HYDROGEL
Oculus Innovative Sciences, Inc.
FRO
Mar 1, 2010K093155VASHE WOUND CLEANSING SYSTEM
Puricore, Inc.
FRO
Feb 17, 2010K100218BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
Coloplast A/S
FRO
Feb 17, 2010K093188AFM ULTRA AG DRESSINGS
Milliken & Co.
FRO
Feb 16, 2010K093544TROPAZONE CR
Midlothian Laboratories
FRO
Jan 26, 2010K092257JALOSKIN
Fidia Advanced Biopolymers Srl
FRO
Jan 21, 2010K091863AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS
Aubrey, Inc.
FRO
Jan 15, 2010K092878PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE
Prugen IP Holdings, Inc.
FRO
Jan 7, 2010K093349MEDLINE CURAD WOUND DRESSINGS
Medline Industries, Inc.
FRO
Jan 7, 2010K090345MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL
Conseal International, Inc.
FRO
Dec 16, 2009K091034AQUACEL AG SURGICAL
Convatec
FRO
Dec 10, 2009K093227SILVERSTREAM AND DERMASEPT
Enzysurge , Ltd., IL
FRO
Dec 7, 2009K093051HYLATOPIC PLUS EMOLLIENT FOAM
Collegium Pharmaceutical Incorporated
FRO
Nov 12, 2009K092826ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL
American Biotech Labs
FRO
Oct 30, 2009K083133SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS
Andover Healthcare, Inc.
FRO
Oct 21, 2009K091354ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING
Acrymed, Inc.
FRO
Oct 9, 2009K092297ELETONE CREAM
Ferndale Pharma Group, Inc.
FRO
Sep 4, 2009K090254SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)
Convatec, A Division of E.R. Squibb & Sons, LLC
FRO
Aug 19, 2009K092232MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014
Puricore, Inc.
FRO
Aug 13, 2009K090337TROPAZONE LOTION
Midlothian Laboratories
FRO
Aug 13, 2009K081246TT-102
Tissue Technologies Holdings, LLC
FRO
Aug 7, 2009K090791DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%
Century Pharmaceuticals, Inc.
FRO
Jul 30, 2009K091719NEOSALUS LOTION
Quinnova Pharmaceuticals
FRO
Jul 30, 2009K091013SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND
Advanced Medical Solutions Limited, GB
FRO

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