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3,119 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
DETECT (K121206)Forum Engineering Technologies, Ltd.2013-01-10
NEW COMFORT-FIT DENTAL GUARD (K123849)Den Tek Oral Care, Inc.2013-01-10
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY (K123731)Glaxosmithkline Consumer Healthcare (Gskch)2013-01-04
LACRIFAST (K120886)Hiroyasu Higuchi2012-12-17
NIXALL TM WOUND AND SKIN CARE (K113693)Seriously Clean, Ltd.2012-12-11
L.A.M. IMP WOUND GEL (K123113)Glycobiosciences, Inc.2012-12-11
CURALINE POLYURETHANE FOAM AWC DRESSING (K121361)Curaline, Inc.2012-11-30
HYLATOPICPLUS LOTION (K121559)Precision Dermatology Incorporated2012-11-30
ILLICO FS FACET FIXATION SYSTEM (K123218)Alphatec Spine, Inc.2012-11-28
HEMASORB APPLY (K121953)Orthocon, Inc.2012-11-21
THERMOFORMED MOUTHGUARDS (K121365)Glidewell Laboratories-Sleep Devices Group2012-11-20
NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING (K122886)Hemostasis, LLC2012-11-15
DCS LACRIMAL STENT (K113316)Dcs Surgical, Inc.2012-11-08
COLLAGEN DENTAL WOUND DRESSINGS (K122115)Collagen Matrix, Inc.2012-11-01
CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING (K120930)Medtrade Products , Ltd.2012-10-26
SKINTEMP II (K122325)Human Biosciences, Inc.2012-10-26
RESOLUTE FACET SCREW SYSTEM (K121551)Neurostructures, LLC2012-10-23
VENUS FACET SCREW SYSTEM (K120340)Apollo Spine, Inc.2012-10-19
LACRICATH LACRIMAL DUCT CATHETER (K113867)Quest Medical, Inc.2012-10-19
QBTES (K122149)Qbtech AB2012-10-17
PROTECH DENT (K121272)Akervall Technologies, Inc.2012-10-15
BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) (K113836)Avery Dennison Belgie Bvba2012-09-24
VESTIBULAR ANALYSIS APPARATUS (K121590)Capacity Sports, LLC2012-09-20
Typhoon(TM) Facet Screw Fixation System (K121850)Choicespine, LP2012-09-20
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER (K121614)Boston Scientific Corp2012-09-18
LOUTREX TOPICAL CREAM (K120730)Acella Pharmaceuticals, LLC2012-09-06
DACRYOCATH (K113508)Armadillo Biomedical, LLC2012-08-31
ENLUXTRA HUMIFIBER WOUND DRESSING (K122297)Basf Venture Capital America, Inc.2012-08-28
HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY (K121550)Ethicon Endo-Surgery, LLC2012-08-22
GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING (K121485)Hemcon Medical Technologies Europe, Ltd.2012-08-21
SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER (K121819)Covalontechnologies, Inc.2012-08-13
LIFECELL TISSUE EXPANDER (K112534)Lifecell Corp.2012-08-10
CRAWFORD BIOCANALICULUS INTUBATION (K121142)Fci Sas (France Chirurgie Instrumentation)2012-08-09
NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER (K113820)Novabay Pharmaceuticals2012-08-08
MASTERKA 40 MASTERKA 35 MASTERKA 30 (K113536)Fci Sas (France Chirurgie Instrumentation)2012-08-03
SOFTSEAL-C (K112864)Chitogen, Inc.2012-08-02
CELOX GAUZE PRO (K113560)Medtrade Products , Ltd.2012-08-01
STENTUBE LACRIMAL INTUBATION SET (K113118)Quest Medical, Inc.2012-07-31
AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER (K121275)Convatec, Inc.2012-07-25
TL TRISEB CREAM (K121134)Trigen Laboratories, Inc.2012-07-25
POSISEP AND POSISEP X HEMOSTAT DRESSINGS (K120958)Hemostasis, LLC2012-07-25
OXYBAND WOUND DRESSING (K121407)O2s, LLC2012-07-09
POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) (K121522)Polyremedy, Inc.2012-06-27
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD (K113326)Oralabs, Inc.2012-06-27
PROCOLL (K120339)Innocoll Pharmaceuticals2012-06-21
I-ROOT 100 (K112508)S-Denti Co., Ltd.2012-06-19
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA (K120552)Biocosmetics Laboratories2012-06-06
HEALEX BIOSPONGE WOUND DRESSING (K112191)Bionova Medical, Inc.2012-06-05
COLLAGEN WOUND DRESSING (K112580)Dalim Tissen Co., Ltd.2012-06-01
CELVER (K111382)Cellulose Concepts, LLC2012-05-31
SUNTOUCH TOPICAL HEMOSTATIC DRESSING (K112800)Huizhou Foryou Medical Devices Co., Ltd.2012-05-23
HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX (K111575)Orthocon, Inc.2012-05-23
MANUKA IG (K120976)Links Medical Products, Inc.2012-05-23
MANUKA FILL (K121227)Links Medical Products, Inc.2012-05-23
HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 (K120729)Ethicon Endo-Surgery, LLC2012-05-17
IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER (K112549)Covalontechnologies, Inc.2012-05-04
COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL (K113660)Cryotherapy Products, Inc.2012-05-03
PSYCHEMEDICS PHENCYCLIDINE EIA (K111928)Psychemedics Corp.2012-05-01
DRY MOUTH MOUTHWASH (K111250)Dr. Fresh, Inc.2012-04-27
IROOT 100 MINI (K112153)S-Denti Co., Ltd.2012-04-26
SALINE WOUND WASH (K112666)Nanoplas, Inc.2012-04-20
HEMCON HEMOSTATIC GEL (K112215)Hemcon Medical Technologies Europe, Ltd.2012-04-12
CURAD ANTIBACTERIAL BANDAGE (K113583)Medline Industries, Inc.2012-04-12
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE (K113839)Parkell, Inc.2012-04-12
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES (K120828)Coloplast A/S2012-04-05
PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX (K113866)Brennen Medical, LLC2012-03-23
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE (K111702)Fenwal, Inc.2012-03-22
DEXERYL CREAM (K113807)Pierre Fabre Medical Devices2012-03-07
ACTIVATOR V-E (K112606)Activator Methods International, Ltd.2012-03-06
AONGEN DENTAL COLLAGEN MATRIX (K112568)Aeon Astron Europe B.V.2012-03-01
BARF BAND (K110821)Doodlebug Products, LLC2012-02-27
SITESCRUB IPA DEVICE (K112791)C. R. Bard2012-02-24
INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP (K113570)Integra Burlington Ma, Inc.2012-02-22
HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY (K113627)Orthocon2012-02-17
MESO WOUND MATRIX (K112888)Kensey Nash Corporation2012-02-10
INTEGRA WOUND MATRIX (THIN) (K113104)Integra LifeSciences Corporation2012-02-09
HPR PLUS EMOLLIENT FOAM (K113774)Prugen IP Holdings, Inc.2012-02-09
HPR EMOLLIENT FOAM (K113772)Prugen IP Holdings, Inc.2012-02-09
REST ASSURED GENERATION III DENTAL PROTECTOR (K120103)Ranir, LLC2012-02-03
REST ASSURED READY TO WEAR NITE PROTECTOR (K112879)Ranir, LLC2012-01-27
SPECTRA OPTIA APHERESIS SYSTEM (K113480)Caridianbct, Inc..2012-01-20
DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX (K112868)Dreamgard, Inc.2012-01-19
REPROCESSED HARMONIC SCALPEL (K111794)Sterilmed, Inc.2012-01-11
DUOFERTILITY (K102499)Cambridge Temperature Concepts , Ltd.2011-12-20
EXSALT T7 WOUND DRESSING (K113564)Exciton Technologies, Inc.2011-12-15
PRECISION SKIN EMULSION (K111168)Precision Dermatology Incorporated2011-12-13
SOMNOBRUX SPLINTS (K102909)Somnomed, Inc.2011-12-13
SYNTHES HEMOSTATIC BONE PUTTY (K113079)Synthes (Usa) Products, LLC/Norian Corporation2011-12-13
BRUX MOUTHGUARDS (K111310)Dental Arte, Inc.2011-12-08
3M TEGADERM MATRIX DRESSING (K110457)3M Company2011-12-07
SPARTAN S3 FACET SYSTEM (K113011)Amendia, Inc.2011-12-06
ADVANCED TRAUMA DRESSING (ATD) (K101257)Nanosys, Inc.2011-12-01
RAPTOR FACET FIXATION SYSTEM (K110170)Alphatec Spine, Inc.2011-11-28
MIGRA TAB, QUICKSPLINT MIGRAINE (K111066)Migratherapy, LLC2011-11-22
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 (K112097)Exactech, Inc.2011-11-21
AVO BARRIER TOPICAL EMULSION (K110762)Trigen Laboratories, Inc.2011-11-18
BINGO PRO (K111474)Forum Engineering Technologies (96) , Ltd.2011-11-02
MEDICAL MAGGOTS, LESOC (K102827)Monarch Labs, LLC2011-11-02
CLO-SURPLUS P.A.D. (K112961)Scion Cardio-Vascular, Inc.2011-10-31
CHX=CHX PLUS (K112250)Inter-Med, Inc.2011-10-28
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