FDA 510(k) clearances — page 468

176,542 clearances on record, most recent first.

Clearances — page 468

46,701–46,800 of 176,542

K111474 — BINGO PROForum Engineering Technologies (96) , Ltd.·Product code LQY·2011-11-02
K112185 — FOURSNARE VASCULAR RETRIEVAL SNARECook, Inc.·Product code MMX·2011-11-02
K112262 — REFLEX BALLON GUIDE CATHETERReverse Medical Corporation·Product code DQY·2011-11-02
K112931 — LEUCADIA(TM) MIS PEDICLE SCREW SYSTEMPhygen, LLC·Product code NKB·2011-11-02
K112962 — SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)Spacelabs Medical, Inc.·Product code MHX·2011-11-02
K112965 — NANO SUTURE ANCHORLinvatec Corporation D/B/A Conmed Linvatec·Product code MBI·2011-11-02
K113036 — U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONSKimberly-Clark Corporation·Product code HEB·2011-11-02
K100784 — UC-CARE NAVIGO SYTEMUC-CARE , Ltd.·Product code LLZ·2011-11-01
K102047 — LCI OPTION FOR INNOCORInnovision A/S·Product code BZC·2011-11-01
K103338 — COOLTOUCHNew Star Lasers, Inc.·Product code PDZ·2011-11-01
K110221 — EYE-CEPT STERILE SALINE SOLUTIONOptics Laboratory, Inc.·Product code LPN·2011-11-01
K111028 — EUS BALLOONUnited States Endoscopy Group, Inc.·Product code FDF·2011-11-01
K112932 — TRANSTEKZhongshan Transtek Electronics Co., Ltd.·Product code MNW·2011-11-01
K112951 — BODY ANALYSIS SCALEShenzhen Healthcare Electronic Technology Co., Ltd.·Product code MNW·2011-11-01
K111683 — FLIGHT 60 VENTILATORFlight Medical Innovations , Ltd.·Product code CBK·2011-10-31
K112345 — DISTAL VOLAR RADIUS PLATING SYSTEMSMedos International SARL·Product code LXT·2011-10-31
K112961 — CLO-SURPLUS P.A.D.Scion Cardio-Vascular, Inc.·Product code QSY·2011-10-31
K103155 — SUMO ACCESS AND TISSUE RESECTION SYSTEMApollo Endosurgery, Inc.·Product code ODC·2011-10-28
K103251 — DUOCENTRIC REVERSEDAston Medical·Product code PHX·2011-10-28
K103278 — ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTIONI-Sens, Inc.·Product code CGA·2011-10-28
K110057 — MINI MASSEUSEMj Specialty Retail·Product code NGX·2011-10-28
K110594 — GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORSNihon Kohden Corp.·Product code CCK·2011-10-28
K111693 — PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical Systems·Product code MKJ·2011-10-28
K111988 — EASYSCAN MODEL 1.2I-Optics BV·Product code MYC·2011-10-28
K112107 — BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUSNeurovirtual USA, Inc.·Product code GWQ·2011-10-28
K112250 — CHX=CHX PLUSInter-Med, Inc.·Product code KJJ·2011-10-28
K112259 — NOBELACTIVE 3.0 GOLDADAPT ABUTMENTSNobel Biocare AB·Product code NHA·2011-10-28
K112277 — BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+BBecton, Dickinson and Company·Product code PSZ·2011-10-28
K112445 — SOFRELINER TOUGH STokuyama Dental Corporation·Product code EBI·2011-10-28
K113091 — SYRINGES AND NEEDLESJiangyin Caina Technology Co., Ltd.·Product code FMF·2011-10-28
K110206 — AESCULAP- MEITHKE SHUNT SYSTEMAesculap, Inc.·Product code JXG·2011-10-27
K110326 — OSRAM ITOSOsram Sylvania, Inc.·Product code ERA·2011-10-27
K110655 — MAHE PERFECT SPINE- PEDICLE SCREW SYSTEMMahe Medical GmbH·Product code NKB·2011-10-27
K111010 — SPIDERFX EMBOLIC PROTECTION DEVICEEv3, Inc.·Product code NTE·2011-10-27
K111296 — ZOLL RESCUENETLINKZoll Medical Corporation, World Wide Headquarters·Product code MSX·2011-10-27
K111434 — GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-LGiotto USA, LLC·Product code MUE·2011-10-27
K111723 — TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEMEv3, Inc.·Product code MCW·2011-10-27
K111796 — INVIZIA ANTERIOR CERVICAL PLATE SYSTEMZimmer Spine, Inc.·Product code KWQ·2011-10-27
K112178 — JMS APHERESIS NEEDLE SET WINGEATER(R) V2JMS North America Corporation·Product code FIE·2011-10-27
K112222 — ALCATRON AND / OR MULTIPLE BRANDAlcatron Gloves Factory·Product code LYZ·2011-10-27
K112466 — 4MP COLOR LCD MONITOR, RADIFORCERX430Eizo Nanao Corporation·Product code LLZ·2011-10-27
K112529 — TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLERAdvanced Instrumentations, Inc.·Product code KNG·2011-10-27
K112604 — 21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)Totoku Electric Co., Ltd.·Product code LLZ·2011-10-27
K112631 — VSI GUIDEWIREVascular Solutions, Inc.·Product code DQX·2011-10-27
K112670 — DX-D 600Agfa Healthcare N.V.·Product code KPR·2011-10-27
K112713 — NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTSNorfolk Medical Products, Inc.·Product code LJT·2011-10-27
K112844 — REHASTIM 2, REHAMOVE 2Hasomed GmbH·Product code GZI·2011-10-27
K112849 — FIXATE TISSUE BANDAnulex Technologies, Inc.·Product code GZB·2011-10-27
K112911 — FETAL DOPPLERBeijing Choice Electronic Technololgy Co., Ltd.·Product code KNG·2011-10-27
K112917 — ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUIDMedtronic, Inc.·Product code DQY·2011-10-27
K110551 — EXPEDIUM SPINE SYSTEMJohnson & Johnson·Product code NKB·2011-10-26
K111512 — BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEMThompson Mis, Inc.·Product code MAX·2011-10-26
K111520 — IPC POWEREASE SYSTEMMedtronic Xomed, Inc.·Product code HBE·2011-10-26
K111621 — MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORSMasimo Corporation·Product code DQA·2011-10-26
K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHDiagnostica Stago, Inc.·Product code KFF·2011-10-26
K111828 — CLEARSPLINT ESAstron Dental Corporation·Product code MQC·2011-10-26
K112000 — VITEK 2 STREPTOCOCCUS PENICILLINbioMerieux, Inc.·Product code LON·2011-10-26
K112174 — NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEMZimmer, Inc.·Product code HRS·2011-10-26
K112520 — US-101L, US-103SIto Co., Ltd.·Product code IMI·2011-10-26
K112689 — SYNTHES STERNAL FIXATION SYSTEMSynthes, Inc.·Product code HRS·2011-10-26
K112810 — MULTI-ANALYTE DETECTION SYSTEMSBio-Rad Laboratories·Product code NHX·2011-10-26
K102454 — I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEMRespironics Respiratory Drug Delivery (Uk) , Ltd.·Product code CAF·2011-10-25
K110998 — AFFIRM (TM) VCF SYSTEMAlgea Therapies·Product code NDN·2011-10-25
K111538 — SKAFFOLD CISSkeletal Kinetics, LLC·Product code MTJ·2011-10-25
K111825 — ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERSCovidien, Formerly US Surgical A Divison of Tyco H·Product code GDW·2011-10-25
K111965 — VUSION(R) OSOrtho Development·Product code MAX·2011-10-25
K112192 — NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENSBausch & Lomb, Inc.·Product code MVN·2011-10-25
K112249 — HEALIX KNOTLESS(TM) ANCHORDepuy Mitek, A Johnson & Johnson Company·Product code MAI·2011-10-25
K112701 — CHARGER BALLOON DILATATION CATHETERBoston Scientific·Product code FGE·2011-10-25
K112786 — PROSERIES BIOIMPLANTS-PROANKLE/PROCUFFSynovis Orthopedic and Woundcare, Inc.·Product code FTM·2011-10-25
K112828 — REVIVE INTERMEDIATE CATHETER (REVIVE IC)Codman & Shurtleff, Inc.·Product code DQY·2011-10-25
K112842 — AMS ELEVATE PCAmerican Medical Systems, Inc.·Product code OTP·2011-10-25
K102329 — NANOKNIFE SYSTEMAngioDynamics, Inc.·Product code OAB·2011-10-24
K102387 — MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIESMediscope Manufacturing, Inc.·Product code JDR·2011-10-24
K103513 — LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLAAdvanced Orthopaedic Solutions, Inc.·Product code HRS·2011-10-24
K110569 — AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)Inovise Medical, Inc.·Product code MLO·2011-10-24
K110783 — VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGEL&K BIOMED Co., Ltd.·Product code MAX·2011-10-24
K111948 — WINGEATER V2JMS North America Corporation·Product code FIE·2011-10-24
K111993 — FRAMEWALKERQuantum Medical Concepts, LLC·Product code KTT·2011-10-24
K112177 — SOFIA ANALYZER AND INFLUENZA A+B FIAQuidel Corp.·Product code PSZ·2011-10-24
K112497 — MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KITC.R. Bard, Inc.·Product code DTK·2011-10-24
K112803 — PATIENT MONITORGuangdong Biolight Meditech Co., Ltd.·Product code MHX·2011-10-24
K103684 — VRESELECT CULTURE MEDIUMBio-Rad·Product code JSO·2011-10-21
K103791 — PHYSIOGLOVE ES WITH ECG ANALYSISCommwell , Ltd.·Product code DPS·2011-10-21
K110992 — ENSPIRE DEBRIDER SYSTEMSpine View, Inc.·Product code HRX·2011-10-21
K111030 — E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEMIntromedic Co., Ltd.·Product code EOX·2011-10-21
K111639 — FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care·Product code KDI·2011-10-21
K111854 — AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVERSt. Jude Medical Systems AB·Product code DRG·2011-10-21
K112166 — ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDEW and R Investments Dba Laser Engineering·Product code GEX·2011-10-21
K112292 — REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETERStryker Sustainability Solutions·Product code NLH·2011-10-21
K112415 — LIFECARE ARM & LEG PAIN RELIEF SYSTEMEveryway Medical Instruments Co.,Ltd·Product code NUH·2011-10-21
K112473 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek, Inc.·Product code NKB·2011-10-21
K112746 — DIOSLIMON IMPLANT SYSTEMDio Corporation·Product code DZE·2011-10-21
K101286 — SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04Linde Healthcare AB·Product code BZR·2011-10-20
K102278 — QUADRA BLOC TENS PLUSGradient Technologies, LLC·Product code GZJ·2011-10-20
K102416 — BD GENEOHM VANR ASSAYBd Diagnostics Science·Product code NIJ·2011-10-20
K103320 — SYNTHES XRLSynthes Spine Co.Lp·Product code MQP·2011-10-20
K103348 — DIGIVIEW 250Kub Technologies, Inc.·Product code MQB·2011-10-20
K110315 — NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICENexgen Medical Systems, Inc.·Product code QEZ·2011-10-20
K110432 — VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABNAffinity Biologicals, Inc.·Product code GGN·2011-10-20

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