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

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RecordFirmDate
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (K140026)Lacrimedics, Inc.2014-06-03
CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT (K133121)Sam Medical Products2014-05-22
ASAP OTC WOUND DRESSING GEL (K140483)Abl Medical, LLC2014-05-20
ROSS RU SKIN DISCONTINUITIES (K131176)Biotd S.A.2014-05-12
GORE BIO-A WOUND MATRIX (K132397)W. L. Gore & Associates, Inc.2014-05-07
MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER) (K133934)Links Medical Products, Inc.2014-05-02
SILVERLON ISLAND WOUND DRESSING (K122817)Argentum Medical, LLC2014-05-01
REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY (K133672)Stryker Sustainability Solutions2014-05-01
COLLACARE DENTAL (K133290)Innocoll Pharmaceuticals2014-05-01
PURACYN PLUS SKIN AND WOUND (K133542)Innovacyn, Inc.2014-04-28
BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE (K140147)Bio-Medical Carbon Technology Co., Ltd.2014-04-22
M-PM-DISC (K134015)Merz Dental GmbH2014-04-11
AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL (K130959)Bioplax Limited2014-04-04
PERCLOT TOPICAL (K132105)Cryolife, Inc.2014-04-03
VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ) (K131848)Puricore, Inc.2014-03-31
EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING (K133775)Exciton Technologies, Inc.2014-03-26
QB TEST (K133382)Qbtech AB2014-03-24
MANUKA FILL WOUND DRESSING (K131796)Links Medical Products, Inc.2014-03-14
CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL (K133764)Avery Dennison Belgie Bvba2014-03-13
IPM WOUND GEL BIO (K123193)Glycobiosciences, Inc.2014-03-03
THE BITE GUARD (K132469)International Profit Builders, Inc.2014-02-28
ARTHROSURFACE TOEMOTION (K132496)Arthrosurface, Inc.2014-02-26
RETRACTION PASTE (K130580)Dmg USA, Inc.2014-02-25
MEDICINAL LEECHES (K132958)Biopharm (Uk) , Ltd.2014-02-19
L.A.M. IPM WOUND GEL, IPM DERM GEL (K130781)Glycobiosciences, Inc.2014-02-14
MEPITEL AG (K130040)Molnlycke Health Care2014-02-12
AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY (K140117)Orthocon, Inc.2014-02-11
TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM (K131966)Twin Star Medical, Inc.2014-02-07
GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER (K132383)Gyrus Acmi, Inc.2014-02-04
RAYPEX 6 (K131907)Dentsply International, Inc.2014-01-31
KHAN KINETIC TREATMENT (KKT-M2) (K130666)Optima Health Solutions International Corporation2014-01-23
GRINDGUARD (K133037)Grind Guard Technologies, LLC2014-01-23
QUICKNIT (K131799)Microcopy, Div. of Neo-Flo, Inc.2014-01-16
MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS (K124033)Surgical Instruments Service and Savings, Inc.2014-01-07
HYDROFERA BLUE PU BACTERIOSTATIC DRESSING (K130670)Hydrofera, LLC2014-01-02
NIVATOPIC PLUS (K132329)Nivagen Pharmaceuticals, Inc.2013-12-20
REST ASSURED EXTRA COMFORT NITE PROTECTOR (K133423)Ranir, LLC2013-12-20
HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE (K132522)Ethicon Endo-Surgery, LLC2013-12-16
HYALMIX CREAM (K123678)Igi Laboratories, Inc.2013-12-16
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET (K132429)Terumobct, Inc.2013-12-06
SELF-RETAINING BICANALICULUS INTUBATON SET II (K130375)Fci Sas (France Chirurgie Instrumentation)2013-12-04
HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY (K133314)Ethicon Endo-Surgery, LLC2013-12-03
KNIT-PAK+ (K132526)Premier Dental Products Co.2013-11-26
INTEGRA FACET FIXATION SYSTEM (K132859)Seaspine, Inc.2013-11-18
WOUNDWASH SALINE SPRAY (K123910)Neilmed Pharmaceuticals, Inc.2013-10-29
SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM (K132126)Spectrum Spine, LLC2013-10-28
HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE (K132512)Ethicon Endo-Surgery, LLC2013-10-24
MARIGEN WOUND DRESSING (K132343)Kerecis Limited2013-10-23
HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE (K132612)Ethicon Endo-Surgery, LLC2013-10-17
PRONTOSAN WOUND GEL X (K130857)B.Braun Medical, Inc.2013-10-08
CLEANSER ROOT CANAL (K130180)Cerkamed Wojciech Pawlowski2013-10-03
BLOM-SINGER SEPTAL PERFORATION PROSTHESIS (K131745)Helix Medical, LLC2013-09-17
LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 (K131221)Biomonde2013-08-28
DERMISEB CREAM (K123724)Igi Laboratories, Inc.2013-08-28
JIAJIAN CMN STIMULATOR (K130768)Wuxi Jiajian Medical Instrument Co., Ltd.2013-08-16
COVAGEN (K123756)Covalon Technologies, Ltd.2013-08-16
FACET SCREW SYSTEM (K130863)Spinal USA2013-08-09
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE (K131744)Terumobct, Inc.2013-08-08
PROTHELIAL (K123904)Mueller Medical International, LLC2013-08-07
OVUSENSE (K122337)Fertility Focus, Ltd.2013-08-06
PRIMATRIX DERMAL REPAIR SCAFFOLD (K131286)Tei Biosciences, Inc.2013-08-05
JBAIDS PLAGUE DETECTION KIT (K131729)Biofire Diagnostics, Inc.2013-07-31
OPHTACATH KIT (K123831)France Chirurgae Instrumentation2013-07-29
NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC (K131542)Novabay Pharmaceuticals, Inc.2013-07-24
MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER (K131853)Mentor Worldwide, LLC2013-07-17
FACET FIXX (K131417)Nexxt Spine, LLC2013-07-12
STATSEAL DISC (K130324)Biolife, LLC2013-07-09
ABSOCLEAR (K130553)Pharmaplast S.A.E.2013-07-03
PROCELLERA (K130350)Vomaris Innovations, Inc.2013-07-02
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE (K131181)Omega Laboratories, Inc.2013-06-25
CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING (K123394)Coreleader Biotech Co., Ltd.2013-06-06
AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE (K123481)Convatec, Inc.2013-06-06
ORAMOIST (K122663)Quantum, Inc.2013-05-30
KOMPREDA (K120597)Custom Spine, Inc.2013-05-03
ZYGAFIX SPINAL FACET SCREW SYSTEM (K123932)X-Spine Systems, Inc.2013-05-01
HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM (K122595)Dermal Life, LLC2013-05-01
RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR (K122703)Biophor Diagnostics, Inc.2013-04-25
FIBRILLAR COLLAGEN WOUND DRESSING (K120250)Collafirm, LLC2013-04-21
QUIKCLOT HEMOSTATIC DRESSING (K123387)Z-Medica, LLC2013-04-12
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS (K130813)Mentor Corp.2013-04-11
JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS (K122812)Wuxi Jiajian Medical Instrument Co., Ltd.2013-04-11
SENTREX BIOSPONGE MPD (K123961)Bionova Medical, Inc.2013-04-05
HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY (K123243)Orthocon, Inc.2013-04-05
MEPILEX TRANSFER AG (K123892)Molnlycke Health Care2013-04-05
BD ALCOHOL SWAB (K121655)Becton, Dickinson & CO2013-03-20
INTERVENTIONAL HEMOSTATIC BANDAGE (K120782)Z-Medica Corporation2013-03-20
TX1 TISSUE REMOVAL SYSTEM (K123640)Tenex Health2013-03-20
URGOCLEAN ABSORBENT WOUND DRESSING (K123219)Laboratoires Urgo2013-03-18
SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE (K123161)Smartguard, Inc.2013-03-14
IODOFOAM IODOPHOR FOAM DRESSING (K122634)Progressive Wound Care Technologies, LLC2013-03-12
BIOMONDE LARVAE (K123449)Biomonde (A Trading Name of Zoobiotic Limited)2013-03-05
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING (K123679)3M Company2013-02-28
FACET SCREW SYSTEM (K123497)Facet-Link, Inc.2013-02-28
BRIDGE EXTRACELLULAR COLLEGEN MATRIX (K122502)Harbor Medtech, Inc.2013-02-26
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM (K120181)Huizhou Foryou Medical Devices Co., Ltd.2013-02-14
VASHE WOUND THERAPY SOLUTION (K123072)Puricore, Inc.2013-02-14
VISCOSTAT CLEAR (K123215)Ultradent Products, Inc.2013-02-05
EPIEN ROOT CANAL CLEANSER (K123538)Epien Medical, Inc.2013-02-01
ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY (K122156)Orthocon, Inc.2013-01-28
VASHE SKIN AND WOUND HYDROGEL (K123071)Puricore, Inc.2013-01-24
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