FDA 510(k) clearances — page 427

176,542 clearances on record, most recent first.

Clearances — page 427

42,601–42,700 of 176,542

K123187 — RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULAEdwards Lifesciences, LLC·Product code DWF·2013-02-22
K123459 — ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEMZimmer, Inc.·Product code MBH·2013-02-22
K123615 — IRIS - HIGH STRENGTH GLASS CERAMICDentsply Intl.·Product code EIH·2013-02-22
K123646 — EMORY CARDIAC TOOLBOX 4.0Syntermed, Inc.·Product code KPS·2013-02-22
K123681 — 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COILWipro GE Healthcare Private, Ltd.·Product code MOS·2013-02-22
K123740 — EOSEos Imaging·Product code MQB·2013-02-22
K123809 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code NKB·2013-02-22
K124061 — MRI PATIENT MONITORING SYSTEM (MODEL 865214)Invivo Corporation·Product code MWI·2013-02-22
K130058 — ENDOSCOPIC ULTRASOUND CENTER EU-Y0008Olympus Medical Systems Corp.·Product code IYN·2013-02-22
K130143 — PERSONA NATURAL TIBIA BASEPLATESZimmer, Inc.·Product code JWH·2013-02-22
K113549 — COMFORT COUGHSeoil Pacific Corp.·Product code NHJ·2013-02-21
K120861 — FIN-S MICROIMPLANTCreekside Orthodontics·Product code OAT·2013-02-21
K121735 — FIBER DISK AND BLOCK PERMANENT, TRINIABioloren S.R.L.·Product code EBF·2013-02-21
K122516 — EMBLETTA MPREmbla Systems·Product code MNR·2013-02-21
K122967 — LUCENTSpinal Elements, Inc.·Product code MAX·2013-02-21
K123175 — DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343Conmed Corporation·Product code KCT·2013-02-21
K123337 — VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CMCaldera Medical·Product code OTO·2013-02-21
K123638 — PEKKTON IVORYCendres & Metaux SA·Product code EBG·2013-02-21
K123651 — CINCHLOCK KNOTLESS SUTURE ANCHORPivot Medical·Product code MBI·2013-02-21
K123680 — COPRANCOLORWhite Peaks Dental Systems GmbH & Co. KG·Product code EIH·2013-02-21
K123824 — VITRO FIL LCDfl Industria E Comercio SA·Product code EMA·2013-02-21
K123974 — PERCUTANEOUS INTRODUCER KITTeleflex, Inc.·Product code DYB·2013-02-21
K123994 — DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCALCiba Vision Corporation·Product code LPL·2013-02-21
K124002 — VERIFICATION CONSOLEVarian Medical Systems·Product code LHN·2013-02-21
K124060 — MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEMMedicalgorithmics S.A.·Product code DSI·2013-02-21
K130038 — POWDER-FREE NITRILE EXAMINATION GLOVES, BLUEHl Rubber Industries Sdn Bhd·Product code LZA·2013-02-21
K123424 — MDU5 PLUS STERILE BAGBoston Scientific Corp·Product code ITX·2013-02-20
K123425 — TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SLSmith & Nephew, Inc.·Product code MBI·2013-02-20
K123613 — SYNSPAR ADVANCEDArdent, Inc.·Product code EIH·2013-02-20
K123650 — ARIX RAD ACQUISITION CONSOLECompania Mexicana DE Radiologia Cgr, S.A. DE C.V.·Product code LLZ·2013-02-20
K110941 — REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200Allmed Systems, Inc.·Product code GEX·2013-02-19
K120851 — COMMUNIFY PACS VIEWERCommunify Health, LLC·Product code LLZ·2013-02-19
K121928 — DESARA SLCaldera Medical, Inc.·Product code OTN·2013-02-19
K122477 — LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANTAnsell Healthcare Products, LLC·Product code NUC·2013-02-19
K123154 — ARTAS SYSTEM FROM RESTORATION ROBOTICSRestoration Robotics, Inc.·Product code ONA·2013-02-19
K123469 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILEWear Safe (Malaysia) Sdn Bhd - Facility II·Product code LZA·2013-02-19
K123575 — MAMMOWORKSTATIONImage Diagnost International GmbH·Product code LLZ·2013-02-19
K123588 — INTRADERMAL ADAPTERWest Pharmaceutical Services, Inc.·Product code FMF·2013-02-19
K123595 — NEXUS RMGIKerr Corporation·Product code EMA·2013-02-19
K121608 — VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORSOrtho-Clinical Diagnostics, Inc.·Product code MRG·2013-02-15
K122177 — ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVELElitechgroup·Product code JIT·2013-02-15
K122315 — FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILCOculus Private Limited·Product code LPL·2013-02-15
K122518 — SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGEBm Korea Co., Ltd.·Product code ODP·2013-02-15
K122710 — TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBANDShenzhen Delicate Electronics Co., Ltd.·Product code IYN·2013-02-15
K122726 — CPI RAD VISIONCommunications & Power Industries Canada, Inc.·Product code KPR·2013-02-15
K122894 — GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLICGeistlich Pharma AG·Product code NPM·2013-02-15
K123164 — SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEMSpinefrontier, Inc.·Product code MNH·2013-02-15
K123320 — DIMENSION AMMONIA FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics·Product code JIF·2013-02-15
K123321 — DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare Diagnostics·Product code JIX·2013-02-15
K123525 — GRIDLOCK PLATING SYSTEMTrilliant Surgical, Ltd.·Product code HRS·2013-02-15
K123835 — 2008 HEMODIALYSIS SORBENT SYSTEMRenal Solutions, Inc.·Product code FKT·2013-02-15
K130200 — PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEMAbaxis, Inc.·Product code CHH·2013-02-15
K120038 — A200 KNEE SYSTEMRenovis Surgical Technologies, LLC·Product code OIY·2013-02-14
K120181 — LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MMHuizhou Foryou Medical Devices Co., Ltd.·Product code FRO·2013-02-14
K120673 — DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIESGrandway Technology (Shenzhen) Limited·Product code DXN·2013-02-14
K120675 — DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIESGrandway Technology (Shenzhen) Limited·Product code DXN·2013-02-14
K121241 — MALE LATEX CONDOMNulatex Sdn. Bhd.·Product code HIS·2013-02-14
K121433 — GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSHmd Biomedical, Inc.·Product code LFR·2013-02-14
K121919 — SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IVExact Medical Manufacturing, Inc.·Product code KKX·2013-02-14
K122054 — LIFESTYLES NATURAL PERSONAL LUBRICANTAnsell Healthcare Products, LLC·Product code NUC·2013-02-14
K122184 — ECG CHECKCardiac Designs, LLC·Product code DXH·2013-02-14
K123072 — VASHE WOUND THERAPY SOLUTIONPuricore, Inc.·Product code FRO·2013-02-14
K123166 — TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (PHowmedica Osteonics Corp.·Product code JWH·2013-02-14
K123176 — ISO-GARD CLEARAIR MASKTeleflexmedical, Inc.·Product code CBN·2013-02-14
K123211 — A5 ANESTHESIA DELIVERY SYSTEMDatascope Corp., Patient Monitoring Division·Product code BSZ·2013-02-14
K123235 — EQUAFLOW MULTIVALVE INFUSION CATHETERCook Incorporated·Product code DYB·2013-02-14
K123240 — SPEEDLOCK HIP KNOTLESS FIXATION IMPLANTArthroCare Corporation·Product code MBI·2013-02-14
K123623 — ILLICO MIS POSTERIOR FIXATION SYSTEMAlphatec Spine, Inc.·Product code NKB·2013-02-14
K123647 — CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICEDevon Medical, Inc.·Product code JOW·2013-02-14
K123826 — VITRO MOLARDfl Industria E Comercio SA·Product code EMA·2013-02-14
K123840 — CONNECT FOR DA VINCI SURGICAL SYSTEM(S)Intuitive Surgical, Inc.·Product code NAY·2013-02-14
K123851 — GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEKBionostics, Inc.·Product code JJX·2013-02-14
K123918 — MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEMZimmer, Inc.·Product code HRS·2013-02-14
K130049 — MONOJECT 12ML SYRINGENipro Medical Corporation·Product code FMF·2013-02-14
K130055 — ACON BUP ONE STEP BUPRENORPHINE TEST STRIPGuangzhou Wondfo Biotech Co., Ltd.·Product code DJG·2013-02-14
K120236 — TRANSFERRIN KIT FOR USE ON THE SPAPLUSThe Binding Site Group , Ltd.·Product code DDG·2013-02-13
K121826 — INTEGRA PROXIMAL HUMERAL PLATE SYSTEMAscension Orthopedics, Inc.·Product code HRS·2013-02-13
K123097 — DOSE TRACKING SYSTEM MODEL XIDF-DTS801Toshiba America Medical Systems, In.C·Product code JAA·2013-02-13
K123254 — ULTRASOUND SCANNER FLEX FOCUSB-K Medical Aps·Product code IYN·2013-02-13
K123412 — RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTSK2m, Inc.·Product code OSH·2013-02-13
K123524 — MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEMMedtronic Neurosurgery·Product code JXG·2013-02-13
K113236 — FORYOU NPWT DEVICEForyou Medical Electronics Co, Ltd.·Product code OMP·2013-02-12
K113614 — ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics·Product code NBW·2013-02-12
K120663 — MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPIDako North America, Inc.·Product code MYA·2013-02-12
K121877 — GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATESExactech, Inc.·Product code KWP·2013-02-12
K122925 — NEW STETIC ARTIFICIAL TEETHNew Stetic·Product code ELM·2013-02-12
K123544 — RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETEREv3, Inc.·Product code LIT·2013-02-12
K123705 — TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLSCorin USA·Product code LZO·2013-02-12
K123938 — SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYNSiemens Medical Solutions USA, Inc.·Product code LNH·2013-02-12
K130043 — PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMTeleflexmedical, Inc.·Product code CAC·2013-02-12
K130090 — STA COMPACT MAXDiagnostica Stago, Incorporated·Product code JPA·2013-02-12
K130209 — INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATEDSorin Group Italia S.R.L.·Product code DTZ·2013-02-12
K102751 — LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEMCeragem Medisys, Inc.·Product code NBW·2013-02-11
K121069 — 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK3M Company·Product code MSH·2013-02-11
K122411 — J-SCOPE SYSTEMMyelotec·Product code HRX·2013-02-11
K123116 — CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)Worldmed Manufacturing Sdn. Bhd.·Product code LZA·2013-02-11
K123435 — IPL THERAPY SYSTEMBeijing Sincoheren S&T Development Co, Ltd.·Product code ONF·2013-02-11
K123450 — PHONAK TINNITUS BALANCEPhonak, LLC·Product code KLW·2013-02-11
K123494 — SOLEAConvergent Dental, Inc.·Product code GEX·2013-02-11
K123620 — FILMARRAY RESPIRATORY PANEL (RP)Biofire Diagnostics, Inc.·Product code OCC·2013-02-11

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