FDA 510(k) clearances — page 430

175,770 clearances on record, most recent first.

Clearances — page 430

42,901–43,000 of 175,770

K120595 — UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.·LWJ·2012-10-12
K120652 — RAPICIDE OPA-28 TEST STRIPSerim Research Corp.·JOJ·2012-10-12
K120831 — ANCHORSURENeomedic International S.L.·PBQ·2012-10-12
K121002 — ETEST CEFTAROLINEbioMerieux, Inc.·JWY·2012-10-12
K121317 — COCHLEAR BAHA IMPLANT SYSTEMCochlear Americas·MAH·2012-10-12
K121598 — ME HAIR2GOSyneron Medical, Ltd.·ONF·2012-10-12
K121624 — BIOMET MICROFIXATION NEURO PLATING SYSTEMBiomet Microfixation·GWO·2012-10-12
K121651 — ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEMWrightmedicaltechnologyinc·HRS·2012-10-12
K121688 — MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEMPrismatik Dentalcraft, Inc.·NHA·2012-10-12
K122074 — IFUSE IMPLANT SYSTEMSI-BONE, Inc.·OUR·2012-10-12
K122293 — PIONEER STERNAL CABLE PLATE SYSTEMPioneer Surgical Technology, Inc.·HRS·2012-10-12
K122398 — RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.·JIX·2012-10-12
K122445 — AESPIRE 7900, AESPIRE VIEWDatex-Ohmeda·BSZ·2012-10-12
K122574 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6Edan Instruments, Inc.·IYO·2012-10-12
K122811 — CONNECTOR COMPONENTS WITH BALANCE BIOSURFACEMedtronic, Inc.·DTL·2012-10-12
K121083 — TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINALoma Vista Medical·OZT·2012-10-11
K121379 — PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORYAiron Corporation·CBK·2012-10-11
K121543 — ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMSZimmer, Inc.·KWT·2012-10-11
K121591 — FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)Tekmedic (M) Sdn Bhd·LYY·2012-10-11
K121679 — ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics·NBW·2012-10-11
K121696 — WIRELESS THERMOMETERRaling Medical Company·FLL·2012-10-11
K121722 — ESA620 ELECTRICAL SAFETY ANALYZERFluke Biomedical·DRT·2012-10-11
K121796 — WECK REUSABLE OBTURATORTeleflexmedical, Inc.·GCJ·2012-10-11
K121883 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KITKci USA, Inc. (Kinetic Concepts, Inc.)·OMP·2012-10-11
K122168 — VISUALIF CHALLENGING ACCESS PLATESpine Smith Partners L.P.·OVD·2012-10-11
K122178 — FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1Ostial Corporation·LOX·2012-10-11
K122233 — CAPSURE(R) PS SYSTEMSpine Wave, Inc.·MNI·2012-10-11
K122463 — APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT WCayenne Medical, Inc.·MBI·2012-10-11
K122600 — LIFEPAK 1000 DEFIBRILLATORPhysio-Control, Inc.·MKJ·2012-10-11
K122778 — PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyinc·KWA·2012-10-11
K122796 — CXI SUPPORT CATHETERCook, Inc.·KRA·2012-10-11
K122798 — INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELLExactech, Inc.·LPH·2012-10-11
K122910 — ARCHON ANTERIOR CERVICAL PLATE SYSTE,Nu Vasive, Incorporated·KWQ·2012-10-11
K112826 — NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITORMoor Instruments, Ltd.·MUD·2012-10-10
K121754 — BLUE SUI SLINGBoston Scientific Corp·OTN·2012-10-10
K122504 — FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTHUnited Orthopedic Corporation·LPH·2012-10-10
K112837 — VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)Vilex, Inc.·JDR·2012-10-09
K121076 — ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGEToshiba America Medical Systems, In.C·LLZ·2012-10-09
K121758 — CERNER FETALINK+(VERSION1.0)Cerner Corp.·HGM·2012-10-09
K122025 — BRIGHTGLASS BRIGHTGLASS MKtk Medical Supplies GmbH·EBG·2012-10-09
K122031 — NEXTRA TI HAMMERTOE CORRECTION SYSTEMNextremity Solutions, LLC·HWC·2012-10-09
K122531 — SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TCovidien·JOH·2012-10-09
K122769 — REMSTAR SERespironics, Inc.·BZD·2012-10-09
K122773 — CROSS-OVER ACETABULAR SHELL & LINERStelkast Company·OQG·2012-10-09
K122816 — AXCESS SOFT TIP WIRE GUIDEWilson-Cook Medical, Inc.·OCY·2012-10-09
K122842 — RADREX-I, SW V4.00 MODEL DRAD-3000EToshiba America Medical Systems, In.C·MQB·2012-10-09
K113039 — SMITH & NEPHEW RADIOPAQUE TRIAL NECKSSmith & Nephew, Inc.·MEH·2012-10-05
K113726 — EPOC CHLORIDE TEST AND EPOC CREATININE TESTEpocal, Inc.·CGL·2012-10-05
K120040 — REPROCESSED SURGICAL ELECTRIC INSTRUMENTSterilmed, Inc.·NUJ·2012-10-05
K120093 — BTL ELITEBTL Industries, Inc.·IMJ·2012-10-05
K120401 — ALAMO TAlliance Partners, LLC·MAX·2012-10-05
K120499 — ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEMKci USA, Inc. (Kinetic Concepts, Inc.)·OMP·2012-10-05
K121563 — CORIN TRIFIT TS HIPCorin USA·MEH·2012-10-05
K121631 — SIMPLE T NASAL MASKRespironics, Inc.·BZD·2012-10-05
K121652 — CVUE ADVANCED HYDRA VUEUnilens Corp., USA·LPL·2012-10-05
K121716 — TBS INSIGHTMedimaps Group SA·KGI·2012-10-05
K121728 — TIGER SPINE SYSTEMCorelink, LLC·NKB·2012-10-05
K122099 — BENCOX II STEM, BENCOX METAL HEADCorentec Co., Ltd.·LPH·2012-10-05
K122589 — DFP4343C7Mdi Consultants, Inc.·KPR·2012-10-05
K122697 — PORTA 100HFJob Corporation·IZL·2012-10-05
K122757 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTAlfa Wassermann Diagnostic Technologies, Inc.·CHH·2012-10-05
K122843 — MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITORProdigy Technology Consultant Co., Ltd.·LLZ·2012-10-05
K122921 — C1-6-D ULTRASOUND TRANSDUCERGE Healthcare·ITX·2012-10-05
K120110 — ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLETProfit Point Manufacturing Sdn Bhd·LZA·2012-10-04
K120706 — NIRVANA A PERSONAL LUBRICANTChurch & Dwight Co., Inc.·NUC·2012-10-04
K121047 — HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEMKj Meditech Co., Ltd.·DZE·2012-10-04
K121682 — ACTIVE SCREW BONE SCREWIntelligent Implant Systems, LLC·HWC·2012-10-04
K122012 — Z-MED Z-MED IINuMED, Inc.·OZT·2012-10-04
K122023 — MIXJECT WITH SPRAY HEADMedimop Medical Projects, Ltd.·FMF·2012-10-04
K122044 — STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATORAdvanced Sterilization Products·FRC·2012-10-04
K122231 — XPEED ANY RIDGE INTERNAL IMPLANT SYSTEMMegagen Implant Co., Ltd.·DZE·2012-10-04
K122366 — TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGESpineart·ODP·2012-10-04
K122384 — MINISPIRMir Medical Intl. Research Srl·BZG·2012-10-04
K111518 — STERRAD CHEMIAL INDICATOR STRIP MODEL 14100Advanced Sterilization Products·JOJ·2012-10-03
K111519 — STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202Advanced Sterilization Products·JOJ·2012-10-03
K113650 — ORTHOFIX SCREWBonafix Surgical and Dental Implants, LLC·OAT·2012-10-03
K120125 — SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUFGe Medical Systems Information Technologies, Inc.·DXQ·2012-10-03
K120751 — NIRVANA B PERSONAL LUBRICANTChurch & Dwight Co., Inc.·NUC·2012-10-03
K120951 — SMARTBUILDER SYSTEMOsstem Implant Co., Ltd.·JEY·2012-10-03
K121287 — HT-WEDGED.T. Davis Enterprises Ltd. T/A Hovertech Int'L·FNG·2012-10-03
K121579 — EK DELIVERY DEVICETdak Medical, Inc.·OTZ·2012-10-03
K122009 — AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCERPanasonic Healthcare Co., Ltd.·IYN·2012-10-03
K122114 — LOGIQ S7 EXPERT, LOGIQ S7 PROGE Healthcare·IYN·2012-10-03
K122228 — LIGAFIX INTERFERENCE SCREWSbm Sciences For Bio Materials·MAI·2012-10-03
K122450 — MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVISMitsubishi Heavy Industries, Ltd.·IYE·2012-10-03
K122599 — ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORSiemens Healthcare Diagnostics, Inc.·DDR·2012-10-03
K122737 — GEMINUS FOSSA SPECIFIC PLATE SYSTEMSkeletal Dynamics, LLC·HRS·2012-10-03
K122858 — ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL IIElitechgroup·JFJ·2012-10-03
K122862 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·NKB·2012-10-03
K120148 — AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREWAdvanced Orthopaedic Solutions, Inc.·HSB·2012-10-02
K121364 — SHIGA TOXIN QUIK CHEKTechlab Inc., Corporate Research Center·GMZ·2012-10-02
K121411 — SHIGA TOXIN CHEKTechlab Inc., Corporate Research Center·GMZ·2012-10-02
K121457 — SPEEDICATH COMPACT SET (12 FR)Coloplast Corp.·GBM·2012-10-02
K121597 — ESON NASAL MASKFisher & Paykel Healthcare Limited·BZD·2012-10-02
K121700 — ULTHERA SYSTEMUlthera, Inc.·OHV·2012-10-02
K122123 — 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPEREDDepuy Mitek, Inc., A Johnson and Johnson Company·MBI·2012-10-02
K122133 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGAirstrip Technologies, LP·MWI·2012-10-02
K122267 — GIRAFFE AND PANDA WARMERSOhmeda Medical, A Division of Datex-Ohmeda, Inc.·FMT·2012-10-02
K122619 — EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SETApplied Medical·BTA·2012-10-02
K122756 — PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBINGPenumbra, Inc.·JCX·2012-10-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.