FDA 510(k) clearances — page 465

176,542 clearances on record, most recent first.

Clearances — page 465

46,401–46,500 of 176,542

K110364 — DORNIER MEDILAS D LITEBEAM+ 1470Dornier Medtech America, Inc.·Product code GEX·2011-12-07
K110457 — 3M TEGADERM MATRIX DRESSING3M Company·Product code FRO·2011-12-07
K110698 — NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREETerang Nusa Sdn Bhd·Product code KGO·2011-12-07
K110924 — DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPSSynergetics, Inc.·Product code GEI·2011-12-07
K111483 — JOULE CLEARSENSE LASER SYSTEMSciton, Inc·Product code PDZ·2011-12-07
K112479 — DSJ MASSAGERMego Afek AC , Ltd.·Product code IRP·2011-12-07
K112489 — SWIFT FX BELLAResmed, Ltd.·Product code BZD·2011-12-07
K112597 — SEITY 37% PHOSPHORIC ACID ETCHANT GELMycone Dental Supply Co., Inc.·Product code KLE·2011-12-07
K113061 — LARGE/EXTRA LAGRE CONDOMKarex Industries Sdn. Bhd.·Product code HIS·2011-12-07
K113179 — ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI·Product code IYN·2011-12-07
K113182 — EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETEREdwards Lifesciences, LLC·Product code DXC·2011-12-07
K110700 — ASCENSION ATLAS HUMERAL PLATING SYSTEMAscension Orthopedics, Inc.·Product code HRS·2011-12-06
K111363 — PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIALMedica Corp.·Product code JXN·2011-12-06
K111637 — INFRARED EAR THERMOMETERRadiant Innovation, Inc.·Product code FLL·2011-12-06
K111834 — DISCO SUBTALAR IMPLANTTrilliant Surgical, Ltd.·Product code HWC·2011-12-06
K111889 — ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANTZimmer Dental, Inc.·Product code DZE·2011-12-06
K112485 — H-WAVEElectronic Waveform Lab, Inc.·Product code GZJ·2011-12-06
K112565 — NOVAPORT ONE VASCULAR ACCESS CANNULANovalung GmbH·Product code DWF·2011-12-06
K113011 — SPARTAN S3 FACET SYSTEMAmendia, Inc.·Product code MRW·2011-12-06
K113404 — DENTAL 3D PLANNING SOFTWARESymbyo Dental, LLC·Product code LLZ·2011-12-06
K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTSSynthes (Usa)·Product code JDS·2011-12-05
K111732 — AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALERSalient Surgical Technologies, Inc.·Product code GEI·2011-12-05
K111811 — BENDINI(TM) SPINAL ROD BENDING SYSTEMNuvasive, Inc.·Product code OLO·2011-12-05
K112125 — ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KITMeridian Bioscience, Inc.·Product code NJR·2011-12-05
K112583 — SYNTHES CORTICAL SCREWSSynthes (USA) Products, LLC·Product code HWC·2011-12-05
K112592 — AXLE PEEK INTERSPINOUS FUSION SYSTEMX-Spine Systems, Inc.·Product code KWP·2011-12-05
K112610 — SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)Inpro Technology Device Factory·Product code LYZ·2011-12-05
K112832 — EYE CARE CURE CONTACT LENS CASEEye Care and Cure·Product code LRX·2011-12-05
K112845 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITORMicrolife Intellectual Property GmbH·Product code DXN·2011-12-05
K113213 — LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2Biosense Webster, Inc.·Product code DRF·2011-12-05
K113350 — BRIVO NM 615GE Healthcare·Product code KPS·2011-12-05
K113501 — AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)Ameditech, Inc.·Product code DIO·2011-12-05
K110615 — WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLEBebe Toys Manufactory , Ltd.·Product code KKO·2011-12-02
K110701 — ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500DNA Genotek, Inc.·Product code OYJ·2011-12-02
K110786 — ESENSOR WARFARIN SENSITIVITY SALIVA TESTGenMark Diagnostics, Inc.·Product code NSU·2011-12-02
K111751 — VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERSETHICON, Inc.·Product code HIN·2011-12-02
K111907 — DYNAMIC DU SERIES PORTABLE DENTAL UNITShanghai Dynamic Industry Co., Ltd.·Product code EIA·2011-12-02
K111915 — MAGNESIUM ASSAYSekisui Diagnostics P.E.I., Inc.·Product code JGJ·2011-12-02
K111922 — VOCARE MYHEALTH TABLETVocare, Inc.·Product code DRG·2011-12-02
K112003 — VANTAGE TITAN HSRToshibamedical Systems Corporation·Product code LNH·2011-12-02
K112559 — MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEMMedapps, Inc.·Product code DRG·2011-12-02
K112779 — APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)Omnlife Science·Product code LPH·2011-12-02
K112930 — MOBILE MIMMim Software, Inc.·Product code LLZ·2011-12-02
K113143 — IMMULISA SCI-70 ANTIBODY ELISAImmco Diagnostics, Inc.·Product code LLL·2011-12-02
K113235 — PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONSMedtronic, Inc.·Product code DXS·2011-12-02
K113245 — AVAIRA AVAIRA TORIC AVAIRA MULTIFOCALCooperVision, Inc.·Product code LPL·2011-12-02
K113267 — BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORICCooperVision, Inc.·Product code LPL·2011-12-02
K113428 — ANGIOJET ULTRA DVX THROMBECTOMY SETMedrad, Inc.·Product code QEZ·2011-12-02
K101257 — ADVANCED TRAUMA DRESSING (ATD)Nanosys, Inc.·Product code QSY·2011-12-01
K103531 — PRESTIGE 24I; BIOLIS 24I; MGC 240Tokyo Boeki Medisys, Inc.·Product code CFR·2011-12-01
K111146 — NEWPORT HT70 VENTILATORNewport Medical Instruments, Inc.·Product code CBK·2011-12-01
K111248 — NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)Yty Industry (Manjung) Sdn Bhd·Product code LZA·2011-12-01
K111335 — ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321Tosoh Bioscience, Inc.·Product code CKG·2011-12-01
K111458 — GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERSGri Medical & Electronic Technology Co., Ltd.·Product code KKX·2011-12-01
K112082 — GUIDELINER V2 CATHETERVascular Solutions, Inc.·Product code DQY·2011-12-01
K112095 — ACCULIF TL-PEEK IBF CAGECoalign Innovations, Inc.·Product code MAX·2011-12-01
K112126 — GENUINE FIRST AID CPR MASKGenuine First Aid, LLC·Product code CBP·2011-12-01
K112138 — ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANTAstra Tech, Inc.·Product code NHA·2011-12-01
K112181 — HYDROCOIL(R) EMBOLIC SYSTEM (HES)MicroVention, Inc.·Product code HCG·2011-12-01
K112296 — LATERAL BUTTONT.A.G. Medical Products Corporation, Ltd.·Product code MBI·2011-12-01
K112337 — RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVELRandox Laboratories, Ltd.·Product code JJY·2011-12-01
K112782 — MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIESMisonix, Inc.·Product code NRB·2011-12-01
K112806 — JENSEN ZIRCONIAJensen Industries, Inc.·Product code EIH·2011-12-01
K112813 — AMSCO V-PROSteris Corp·Product code MLR·2011-12-01
K112979 — ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIREAsahi Intecc Co., Ltd.·Product code MOF·2011-12-01
K113032 — SNAP WOUND CARE SYSTEMSpiracur, Inc.·Product code OKO·2011-12-01
K113201 — NARVAL CCResmed Sas·Product code LQZ·2011-12-01
K113228 — RENAISSANCE SYSTEMMazor Robotics , Ltd.·Product code HAW·2011-12-01
K103418 — DESARA MINICaldera Medical, Inc.·Product code PAH·2011-11-30
K110106 — VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLEbioMerieux, Inc.·Product code LON·2011-11-30
K110424 — DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLEMedcomp ( Medical Components)·Product code LJT·2011-11-30
K111655 — FLAATZ 760Drtech Corp.·Product code KPR·2011-11-30
K111771 — NON-CONTACT TEAR FILM THERMOGRAGHUnited Integrated Services Co., Ltd.·Product code HKI·2011-11-30
K112354 — 5MP MONOCHROME LCD MONITOR, RADIFORCE GX530Eizo Nanao Corporation·Product code LLZ·2011-11-30
K112361 — ALAMO CAlliance Partners, LLC·Product code ODP·2011-11-30
K112570 — CENTRICITY CARDIO IMAGINGGe Healthcare Integrated IT Solutions·Product code LLZ·2011-11-30
K112697 — CHARGER PTA BALLON DILATATION CATHETERBoston Scientific·Product code LIT·2011-11-30
K102756 — SURECORE BIOPSY DEVICEChest Innovations, Inc.·Product code KNW·2011-11-29
K111087 — FOUNDATIONOlympus Terumo Biomaterials Corporation·Product code LYC·2011-11-29
K111272 — RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEMRhausler, Inc.·Product code OVE·2011-11-29
K111908 — BIOMET MICROFIXATION STERNAL CLOSURE SYSTEMBiomet Microfixation, Inc.·Product code HWC·2011-11-29
K110170 — RAPTOR FACET FIXATION SYSTEMAlphatec Spine, Inc.·Product code MRW·2011-11-28
K111891 — SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTSSynthes (USA) Products, LLC·Product code HSB·2011-11-28
K113153 — DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYO·2011-11-28
K113198 — NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 MLNavilyst Medical, Inc.·Product code DXT·2011-11-28
K113241 — BD EMERALD SINGLE USE, HYPODERMIC SYRINGEBecton Dickinson·Product code FMF·2011-11-28
K112636 — CYTOGUARD(TM) CLOSED LUER CONNECTORB.Braun Medical, Inc.·Product code FPA·2011-11-26
K111342 — LIGHT GUIDE CABLESchott North America·Product code HBI·2011-11-25
K102644 — ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120ISiemens Healthcare Diagnostics·Product code GKZ·2011-11-23
K103483 — INGENUITY TF PET/MRPhilips Healthcare (Cleveland)·Product code OUO·2011-11-23
K103803 — HAMILTON-G5Hamilton Medical AG·Product code CBK·2011-11-23
K110525 — VITALOGRAPH MODEL 7100 - VITALOJAKVitalograph (Ireland) , Ltd.·Product code DSH·2011-11-23
K110605 — ROM PLUSClinical Innovations, LLC·Product code NQM·2011-11-23
K110619 — ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLSBiokit, S.A.·Product code MRG·2011-11-23
K111119 — TRABECULAR METAL (TM) FUSION DEVICEZimmer Spine, Inc.·Product code ODP·2011-11-23
K111242 — MAGNETOM AERA AND MAGNETOM SKYRASiemens Medical Solutions USA, Inc.·Product code LNH·2011-11-23
K111748 — RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511AJoy Long·Product code JOW·2011-11-23
K112150 — PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc·Product code KWA·2011-11-23
K112488 — HOTDOG PATIENT WARMING SYSTEMAugustine Biomedical & Design, LLC·Product code DWJ·2011-11-23
K112564 — QUIXIE NEBULIZEROdyssey Medical Technologies·Product code CAF·2011-11-23

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