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FRO

705 FDA 510(k) clearances · Product code

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RecordFirmDate
LOW ADHERENT AFM AG DRESSINGS (K103141)Milliken Healthcare Products, LLC2011-01-21
BIOMED WOUND CLEANSER (K100613)Biomed Laboratories, Inc.2011-01-05
ACTIVON TULLE (K101118)Calidad Solutions, Inc.2010-12-15
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD (K100261)Tei Biosciences, Inc.2010-12-10
MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER (K102659)Manuka Medical Limited2010-12-08
PRONTOSAN ANTIMICROBIAL WOUND GEL (K101882)B.Braun Medical, Inc.2010-11-03
OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING (K102478)Southwest Technologies, Inc.2010-11-03
EXSALT WOUND DRESSING (K100580)Exciton Technologies, Inc.2010-10-12
MEPILEX BORDER AG DRESSING (K100029)Molnlycke Health Care2010-09-15
AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING (K100693)Medtrade Products Limited2010-08-10
VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 (K100918)Puricore, Inc.2010-08-09
TALYMED (K102002)Marine Polymer Technologies2010-07-28
PR CREAM (K093159)Prugen IP Holdings, Inc.2010-06-24
PRUCLAIR NONSTEROIDAL CREAM (K093156)Prugen IP Holdings, Inc.2010-06-24
DRYODINE CADEXOMER-IODINE GEL (K093320)Collegium Pharmaceutical Incorporated2010-06-18
COLLAWOUND ART (K093351)Collamatrix, Inc.2010-06-16
URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER (K100429)Laboratoires Urgo2010-06-11
URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER (K100430)Laboratoires Urgo2010-06-11
MANUKAPLI WOUND DRESSING (K092689)Manuka Medical Limited2010-05-20
BARIREP (K100839)Gorbec Pharmaceutical Services, Inc.2010-05-11
VASHE WOUND THERAPY SOLUTION (K093697)Puricore, Inc.2010-04-13
POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS (K092351)Polyremedy, Inc.2010-04-08
POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS (K092348)Polyremedy, Inc.2010-04-08
MICROCYN SKIN AND WOUND HYDROGEL (K093585)Oculus Innovative Sciences, Inc.2010-03-08
VASHE WOUND CLEANSING SYSTEM (K093155)Puricore, Inc.2010-03-01
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM (K100218)Coloplast A/S2010-02-17
AFM ULTRA AG DRESSINGS (K093188)Milliken & Co.2010-02-17
TROPAZONE CR (K093544)Midlothian Laboratories2010-02-16
JALOSKIN (K092257)Fidia Advanced Biopolymers Srl2010-01-26
AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS (K091863)Aubrey, Inc.2010-01-21
PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE (K092878)Prugen IP Holdings, Inc.2010-01-15
MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL (K090345)Conseal International, Inc.2010-01-07
MEDLINE CURAD WOUND DRESSINGS (K093349)Medline Industries, Inc.2010-01-07
AQUACEL AG SURGICAL (K091034)Convatec2009-12-16
SILVERSTREAM AND DERMASEPT (K093227)Enzysurge , Ltd.2009-12-10
HYLATOPIC PLUS EMOLLIENT FOAM (K093051)Collegium Pharmaceutical Incorporated2009-12-07
ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL (K092826)American Biotech Labs2009-11-12
SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS (K083133)Andover Healthcare, Inc.2009-10-30
ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING (K091354)Acrymed, Inc.2009-10-21
ELETONE CREAM (K092297)Ferndale Pharma Group, Inc.2009-10-09
SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) (K090254)Convatec, A Division of E.R. Squibb & Sons, LLC2009-09-04
MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 (K092232)Puricore, Inc.2009-08-19
TROPAZONE LOTION (K090337)Midlothian Laboratories2009-08-13
TT-102 (K081246)Tissue Technologies Holdings, LLC2009-08-13
DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% (K090791)Century Pharmaceuticals, Inc.2009-08-07
EXSALT SD7 WOUND DRESSING (K083870)Exciton Technologies, Inc.2009-07-30
SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND (K091013)Advanced Medical Solutions Limited2009-07-30
NEOSALUS LOTION (K091719)Quinnova Pharmaceuticals2009-07-30
ELASTO-GEL MANUKA HONEY WOUND DRESSING (K083334)Southwest Technologies, Inc.2009-07-30
ACTICOAT FLEX 7 DRESSING (K083113)Smith & Nephew, Inc.2009-07-22
CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES (K082910)Aso, LLC2009-06-17
OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER (K090206)Oculus Innovative Sciences, Inc.2009-06-02
OCULUS MICROCYN WOUND GEL (K090725)Oculus Innovative Sciences, Inc.2009-05-20
SOCKIT! AND MCMERLIN DERMAL WOUND GEL (K090092)Mcmerlin Dental Products LP2009-05-11
SILVER WOUND PAD (K083659)Milliken & Co.2009-04-16
PROWICK (K083007)Arthrex, Inc.2009-04-08
ASAP WOUND DRESSING GEL (K082333)American Biotech Labs2009-04-02
NEOSALUS CREAM (K090585)Quinnova Pharmaceuticals2009-04-02
PRONTOSAN ANTIMICROBIAL WOUND GEL (K090141)B.Braun Medical, Inc.2009-03-17
SILVER ALGINATE 11 WOUND DRESSING (K090453)Advanced Medical Solutions Limited2009-02-26
ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B (K083103)Acrymed, Inc.2009-02-26
COPA AMD (K082296)Covidien Lp, Formerly Registered AS Tyco Healthcar2009-02-26
KERATEC WOUND DRESSINGS (K080949)Keratec Limited2009-02-11
PRUMYX CREAM (K082089)Prugen, Inc.2009-01-13
WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 (K083355)Blairex Laboratories, Inc.2008-12-29
WOUND FLUSH, STERILE WATER & NORMAL SALINE (K083042)Nurse Assist, Inc.2008-12-18
PROSIT WOUND TREATMENT DEVICE (K081977)Silverleaf Medical Products, Inc.2008-12-01
SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING (K080503)Advanced Medical Solutions Limited2008-11-12
PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION (K082330)Primary Care Solutions, Inc.2008-10-09
NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING (K081363)Advanced Medical Solutions Limited2008-09-24
ACRYDERM ABSORBENT OXYGEN DRESSING (K082459)Acrymed, Inc.2008-09-19
SILVERMED ANTIMICROBIAL SILVER HYDROGEL (K073019)Argentis Biomedical Incorporated2008-09-16
NEOSALUS (K070309)Quinnova Pharmaceuticals2008-09-12
SILVER ANTIMICROBIAL WOUND GEL (K073197)Advanced Medical Solutions Limited2008-08-28
DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG) (K080497)Derma Sciences Canada, Inc.2008-06-27
DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY (K081584)Derma Sciences, Inc.2008-06-19
PRONTOSAN WOUND IRRIGATION SOLUTION (K072876)B.Braun Medical, Inc.2008-06-19
SURESKIN SILVER BANDAGES (K081274)Euromed, Inc.2008-05-28
THERABOND ANTIMICROBIAL BARRIER SYSTEMS (K073213)Choice Therapeutics2008-05-28
MODIFICATION TO 3M TEGADERM CHG DRESSING (K080620)3M Company-3M Health Care2008-05-19
REVERA WOUND CARE, MODEL MDW0060 (K070463)Revalesio Corporation2008-05-07
AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (K080383)Convatec, A Division of E.R. Squibb & Sons, LLC2008-05-02
SUPRASORB A +AG (K071442)Specialty Fibres and Materials, Ltd.2008-05-01
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING (K071552)Medline Industries, Inc.2008-04-25
DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY (K080315)Derma Sciences, Inc.2008-04-23
ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL (K073547)Anacapa Technologies, Inc.2008-04-23
ELTA ADVANCED WOUND WASH (K073610)Swiss American Products, Inc.2008-04-23
TETRIX CREAM (K071483)Coria Laboratories, Ltd.2008-04-04
RADIO BIOAQUACARE (K080471)Bioartificial Gel Technologies (Bagtech), Inc.2008-03-05
COLLAWOUND HYDROGEL (K071557)Collamatrix Co., Inc.2008-02-08
BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS (K072068)Bioartificial Gel Technologies (Bagtech), Inc.2007-12-21
COPA AMD ANTIMICROBIAL WOUND DRESSING (K071371)Tyco Healthcare Group LP2007-11-19
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 (K072378)Arthrex, Inc.2007-11-09
MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY (K072956)Derma Sciences, Inc.2007-11-07
NEUTROPHASE WOUND CLEANSER (K071056)Novabay Pharmaceuticals2007-09-28
KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 (K070685)Tyco Healthcare2007-09-14
KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 (K070653)Tyco Healthcare2007-09-12
ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC (K071703)Swiss American Products, Inc.2007-08-22
ALLEVYN AG DRESSING (K063835)Smith & Nephew, Inc.2007-08-03
L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE (K053613)Theo Manufacturing BV2007-07-25
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