FDA 510(k) clearances — page 438

176,542 clearances on record, most recent first.

Clearances — page 438

43,701–43,800 of 176,542

K122600 — LIFEPAK 1000 DEFIBRILLATORPhysio-Control, Inc.·Product code MKJ·2012-10-11
K122778 — PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyinc·Product code KWA·2012-10-11
K122796 — CXI SUPPORT CATHETERCook, Inc.·Product code KRA·2012-10-11
K122798 — INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELLExactech, Inc.·Product code LPH·2012-10-11
K122910 — ARCHON ANTERIOR CERVICAL PLATE SYSTE,Nu Vasive, Incorporated·Product code KWQ·2012-10-11
K112826 — NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITORMoor Instruments, Ltd.·Product code MUD·2012-10-10
K121754 — BLUE SUI SLINGBoston Scientific Corp·Product code OTN·2012-10-10
K122504 — FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTHUnited Orthopedic Corporation·Product code LPH·2012-10-10
K112837 — VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)Vilex, Inc.·Product code JDR·2012-10-09
K121076 — ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGEToshiba America Medical Systems, In.C·Product code LLZ·2012-10-09
K121758 — CERNER FETALINK+(VERSION1.0)Cerner Corp.·Product code HGM·2012-10-09
K122025 — BRIGHTGLASS BRIGHTGLASS MKtk Medical Supplies GmbH·Product code EBG·2012-10-09
K122031 — NEXTRA TI HAMMERTOE CORRECTION SYSTEMNextremity Solutions, LLC·Product code HWC·2012-10-09
K122531 — SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TCovidien·Product code JOH·2012-10-09
K122769 — REMSTAR SERespironics, Inc.·Product code BZD·2012-10-09
K122773 — CROSS-OVER ACETABULAR SHELL & LINERStelkast Company·Product code OQG·2012-10-09
K122816 — AXCESS SOFT TIP WIRE GUIDEWilson-Cook Medical, Inc.·Product code OCY·2012-10-09
K122842 — RADREX-I, SW V4.00 MODEL DRAD-3000EToshiba America Medical Systems, In.C·Product code MQB·2012-10-09
K113039 — SMITH & NEPHEW RADIOPAQUE TRIAL NECKSSmith & Nephew, Inc.·Product code MEH·2012-10-05
K113726 — EPOC CHLORIDE TEST AND EPOC CREATININE TESTEpocal, Inc.·Product code CGL·2012-10-05
K120040 — REPROCESSED SURGICAL ELECTRIC INSTRUMENTSterilmed, Inc.·Product code NUJ·2012-10-05
K120093 — BTL ELITEBTL Industries, Inc.·Product code IMJ·2012-10-05
K120401 — ALAMO TAlliance Partners, LLC·Product code MAX·2012-10-05
K120499 — ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEMKci USA, Inc. (Kinetic Concepts, Inc.)·Product code OMP·2012-10-05
K121563 — CORIN TRIFIT TS HIPCorin USA·Product code MEH·2012-10-05
K121631 — SIMPLE T NASAL MASKRespironics, Inc.·Product code BZD·2012-10-05
K121652 — CVUE ADVANCED HYDRA VUEUnilens Corp., USA·Product code LPL·2012-10-05
K121716 — TBS INSIGHTMedimaps Group SA·Product code KGI·2012-10-05
K121728 — TIGER SPINE SYSTEMCorelink, LLC·Product code NKB·2012-10-05
K122099 — BENCOX II STEM, BENCOX METAL HEADCorentec Co., Ltd.·Product code LPH·2012-10-05
K122589 — DFP4343C7Mdi Consultants, Inc.·Product code KPR·2012-10-05
K122697 — PORTA 100HFJob Corporation·Product code IZL·2012-10-05
K122757 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTAlfa Wassermann Diagnostic Technologies, Inc.·Product code CHH·2012-10-05
K122843 — MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITORProdigy Technology Consultant Co., Ltd.·Product code LLZ·2012-10-05
K122921 — C1-6-D ULTRASOUND TRANSDUCERGE Healthcare·Product code ITX·2012-10-05
K120110 — ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLETProfit Point Manufacturing Sdn Bhd·Product code LZA·2012-10-04
K120706 — NIRVANA A PERSONAL LUBRICANTChurch & Dwight Co., Inc.·Product code NUC·2012-10-04
K121047 — HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEMKj Meditech Co., Ltd.·Product code DZE·2012-10-04
K121682 — ACTIVE SCREW BONE SCREWIntelligent Implant Systems, LLC·Product code HWC·2012-10-04
K122012 — Z-MED Z-MED IINuMED, Inc.·Product code OZT·2012-10-04
K122023 — MIXJECT WITH SPRAY HEADMedimop Medical Projects, Ltd.·Product code FMF·2012-10-04
K122044 — STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATORAdvanced Sterilization Products·Product code FRC·2012-10-04
K122231 — XPEED ANY RIDGE INTERNAL IMPLANT SYSTEMMegagen Implant Co., Ltd.·Product code DZE·2012-10-04
K122366 — TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGESpineart·Product code ODP·2012-10-04
K122384 — MINISPIRMir Medical Intl. Research Srl·Product code BZG·2012-10-04
K111518 — STERRAD CHEMIAL INDICATOR STRIP MODEL 14100Advanced Sterilization Products·Product code JOJ·2012-10-03
K111519 — STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202Advanced Sterilization Products·Product code JOJ·2012-10-03
K113650 — ORTHOFIX SCREWBonafix Surgical and Dental Implants, LLC·Product code OAT·2012-10-03
K120125 — SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUFGe Medical Systems Information Technologies, Inc.·Product code DXQ·2012-10-03
K120751 — NIRVANA B PERSONAL LUBRICANTChurch & Dwight Co., Inc.·Product code NUC·2012-10-03
K120951 — SMARTBUILDER SYSTEMOsstem Implant Co., Ltd.·Product code JEY·2012-10-03
K121287 — HT-WEDGED.T. Davis Enterprises Ltd. T/A Hovertech Int'L·Product code FNG·2012-10-03
K121579 — EK DELIVERY DEVICETdak Medical, Inc.·Product code OTZ·2012-10-03
K122009 — AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCERPanasonic Healthcare Co., Ltd.·Product code IYN·2012-10-03
K122114 — LOGIQ S7 EXPERT, LOGIQ S7 PROGE Healthcare·Product code IYN·2012-10-03
K122228 — LIGAFIX INTERFERENCE SCREWSbm Sciences For Bio Materials·Product code MAI·2012-10-03
K122450 — MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVISMitsubishi Heavy Industries, Ltd.·Product code IYE·2012-10-03
K122599 — ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORSiemens Healthcare Diagnostics, Inc.·Product code DDR·2012-10-03
K122737 — GEMINUS FOSSA SPECIFIC PLATE SYSTEMSkeletal Dynamics, LLC·Product code HRS·2012-10-03
K122858 — ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL IIElitechgroup·Product code JFJ·2012-10-03
K122862 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code NKB·2012-10-03
K120148 — AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREWAdvanced Orthopaedic Solutions, Inc.·Product code HSB·2012-10-02
K121364 — SHIGA TOXIN QUIK CHEKTechlab Inc., Corporate Research Center·Product code GMZ·2012-10-02
K121411 — SHIGA TOXIN CHEKTechlab Inc., Corporate Research Center·Product code GMZ·2012-10-02
K121457 — SPEEDICATH COMPACT SET (12 FR)Coloplast Corp.·Product code GBM·2012-10-02
K121597 — ESON NASAL MASKFisher & Paykel Healthcare Limited·Product code BZD·2012-10-02
K121700 — ULTHERA SYSTEMUlthera, Inc.·Product code 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·Product code MBI·2012-10-02
K122133 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGAirstrip Technologies, LP·Product code MWI·2012-10-02
K122267 — GIRAFFE AND PANDA WARMERSOhmeda Medical, A Division of Datex-Ohmeda, Inc.·Product code FMT·2012-10-02
K122619 — EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SETApplied Medical·Product code BTA·2012-10-02
K122756 — PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBINGPenumbra, Inc.·Product code JCX·2012-10-02
K113678 — INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEMMedela AG·Product code OMP·2012-10-01
K120116 — SERF ABLATION SYSTEM SERF ABLATION NEEDLEThermedical·Product code GEI·2012-10-01
K120460 — SMARTLUXMedmix Co., Ltd.·Product code GEX·2012-10-01
K120891 — TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEMUlrich GmbH & Co. KG·Product code NKB·2012-10-01
K120998 — SOLSTICE CROSS CONNECTORLife Spine·Product code KWP·2012-10-01
K121425 — ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEMWrightmedicaltechnologyinc·Product code HRS·2012-10-01
K121458 — SPEEDICATH COMPACT SET (12/18 FR)Coloplast A/S·Product code GBM·2012-10-01
K121672 — AFT PROXIMAL HUMERUS FRACTURE PLATEShoulder Options, Inc.·Product code HRS·2012-10-01
K121684 — NOVATION LPI PRIME FEMORAL STEMExactech, Inc.·Product code LPH·2012-10-01
K122226 — REVERE STABILIZATION SYSTEMGlobus Medical, Inc.·Product code NKB·2012-10-01
K122308 — AXSOS DISTAL LATERAL FEMUR TS LONG PLATESHowmedica Osteonics Corp., Dba Stryker Orthopaedics·Product code HRS·2012-10-01
K122511 — ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATHEthicon Endo-Surgery, LLC·Product code GCJ·2012-10-01
K112628 — NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SETNipro Medical Corporation·Product code FJK·2012-09-28
K113852 — BAUSCH & LOMB IOL INJECTORBausch & Lomb, Inc.·Product code MSS·2012-09-28
K120289 — PEERSCOPE SYSTEMPeermedical·Product code FDF·2012-09-28
K120982 — DIGITAL EYE-FUNDUS CAMERAMedimaging Integrated Solutions, Inc. (Miis)·Product code HKI·2012-09-28
K121286 — EPIC 10Biolase Technology, Inc.·Product code GEX·2012-09-28
K121462 — EZ-BLOCKEREz-Blocker B.V.·Product code CBI·2012-09-28
K121761 — SOMNOGUARD SP SOFTTomed Dr. Toussaint GmbH·Product code LRK·2012-09-28
K121806 — BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARECovidien·Product code DQA·2012-09-28
K121915 — BRIGHT RESTORATIVE MATERIALSDmp, Ltd.·Product code EBF·2012-09-28
K122072 — WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STEBoston Scientific Corporation·Product code FGE·2012-09-28
K122232 — GMK NARROWMedacta International·Product code JWH·2012-09-28
K122263 — 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USESymmetry Medical·Product code ODY·2012-09-28
K122270 — OVERTUBE ENDOSCOPIC ACCESS SYSTEMApollo Endosurgery, Inc.·Product code FED·2012-09-28
K122433 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek, Inc.·Product code NKB·2012-09-28
K122451 — EXACTRAC VEROBrainlab AG·Product code IYE·2012-09-28
K122641 — MPACT EXTENSIONMedacta International·Product code LZO·2012-09-28

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