FDA 510(k) clearances — page 396

176,542 clearances on record, most recent first.

Clearances — page 396

39,501–39,600 of 176,542

K140254 — EZONO 4000Ezono AG·Product code IYN·2014-02-26
K140282 — ST SENSE NV 8 ARRAY COILResonance Innovations, LLC·Product code MOS·2014-02-26
K130517 — EZ TRANSPORT CHAIRHarris Medical, LLC·Product code IOR·2014-02-25
K130580 — RETRACTION PASTEDmg USA, Inc.·Product code MVL·2014-02-25
K131503 — SE-601 SERIES ELECTROCARDIOGRAPHEdan Instruments, Inc.·Product code DPS·2014-02-25
K132344 — E-Z CHECK OZONE TEST STRIPSReprocessing Products Corporation (Rpc)·Product code MSY·2014-02-25
K132389 — CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKEDDaniel & Daniel Consulting·Product code OWN·2014-02-25
K132599 — SMILEBOND SYSTEMMillennium Company, LLC·Product code ELW·2014-02-25
K132690 — UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEMQisda Corporation·Product code IYN·2014-02-25
K132814 — SFI-BAR IMPLANT ABUTMENTSSterngold Dental, LLC·Product code NHA·2014-02-25
K133058 — INSULIN PEN NEEDLEWenzhou Wuzhou Import & Export Co., Ltd.·Product code FMI·2014-02-25
K133059 — INSULIN PEN NEEDLEWenzhou Beipu Science & Technology Co., Ltd.·Product code FMI·2014-02-25
K133137 — CISNAP CLOSED INCISION SYSTEMSpiracur, Inc.·Product code OKO·2014-02-25
K133162 — ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLAMaterialise NV·Product code JWH·2014-02-25
K133177 — MODIFIED HD GUIDE CATHETERConcentric Medical, Inc.·Product code DQY·2014-02-25
K133287 — PRESSON SPINAL FIXATION SYSTEMNexus Spine, LLC·Product code MNH·2014-02-25
K133320 — SICAT FUNCTIONSicat GmbH & Co. KG·Product code LLZ·2014-02-25
K133501 — LEADLINER CS LEAD DELIVERY SYSTEMVascular Solutions, Inc.·Product code DQY·2014-02-25
K133644 — SYNGO.VIA MI WORKFLOWSSiemens Medical Solutions USA, Inc.·Product code LLZ·2014-02-25
K133696 — NEODENT IMPLANT SYSTEMJjgc Industria E Comercio DE Materiais Dentarios S·Product code NHA·2014-02-25
K133904 — CD HORIZON SPINAL SYSTEM GROWTH ROD SETMedtronic Sofamor Danek USA·Product code PGM·2014-02-25
K133968 — WONDFO MULTI-DRUG URINE TEST CUP, PANELGuangzhou Wondfo Biotech Co., Ltd.·Product code DKZ·2014-02-25
K134020 — INTONEMVIncontrol Medical, LLC·Product code KPI·2014-02-25
K140118 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGECardica, Inc.·Product code GDW·2014-02-25
K123697 — MATRICEL DENTAL BARRIER MEMBRANEMatricel GmbH·Product code NPL·2014-02-24
K131252 — PURITAN BENNETT 980 SERIES VENTILATOR SYSTEMCovidien·Product code CBK·2014-02-24
K131909 — DALTON LIFT CHAIRDalton Instrument Corp.·Product code INO·2014-02-24
K132480 — AIR-FLOW HANDY 3.0 PERIOE.M.S Electro Medical Systems S.A·Product code EFB·2014-02-24
K133404 — IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMHPhadia AB·Product code DGC·2014-02-24
K133447 — EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERESCelonova Biosciences, Inc.·Product code NAJ·2014-02-24
K133510 — NEODENT IMPLANT SYSTEMJj Industria E Comercio DE Materiais Dentarios SA·Product code DZE·2014-02-24
K133615 — WELL LEAD PVC HYDROPHILIC URETHRAL CATHETERWell Lead Medical Co., Ltd.·Product code EZD·2014-02-24
K133625 — AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &Codman & Shurtleff, Inc.·Product code MOF·2014-02-24
K133691 — EXTRIMILOCK ANKLE PLATING SYSTEMOsteomed LP·Product code HRS·2014-02-24
K131066 — AXIOM REGAnthogyr Sas·Product code DZE·2014-02-21
K131426 — MEDLINE BIOPSY VALVEMedline Industries, Inc.·Product code OCX·2014-02-21
K131481 — FREEDOM PCK COMPONENTSMaxx Orthopedics, Inc.·Product code JWH·2014-02-21
K131783 — POLAROID CONTACTSPODViopti, Ltd.·Product code LRX·2014-02-21
K131990 — OXYGEN GENERATOR LIQUEFIER - (OGL)Essex Cryogenics of Missouri, Inc.·Product code CAW·2014-02-21
K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIMJedmed Instrument Co.·Product code EQN·2014-02-21
K132158 — NOVOHIP TOTAL HIP SYSTEMNovosource, Inc.·Product code LPH·2014-02-21
K132219 — STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,Straumann USA, LLC·Product code NHA·2014-02-21
K132229 — OMNI PATENT MONITORSInfinium Medical·Product code MWI·2014-02-21
K132402 — SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEMNonin Medical, Inc.·Product code DQA·2014-02-21
K132457 — FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETERBiocare Asia Corporation , Ltd.·Product code FLL·2014-02-21
K132842 — FLAATZ 600 SERIES (FLAATZ 600/601)Drtech Corp.·Product code MQB·2014-02-21
K132874 — LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CMNucletron B.V.·Product code JAQ·2014-02-21
K132935 — ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEMESiemens Medical Solutions USA, Inc.·Product code IYE·2014-02-21
K133234 — T-TYPE D-KAT, R-TYPE D-KATKeeler Limited·Product code HKY·2014-02-21
K133409 — DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGARayence Co., Ltd.·Product code MQB·2014-02-21
K133432 — SHERPA PAK CARDIAC TRANSPORT SYSTEMParagonix Technologies, Inc.·Product code MSB·2014-02-21
K133491 — ADVIA CENTAUR TESTOSTERONE (TSTO)Siemens Healthcare Diagnostics, Inc.·Product code CDZ·2014-02-21
K133509 — EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOOBiotest Medical Corp.·Product code NBW·2014-02-21
K133576 — MONITOR B40Ge Medical Systems China Co., Ltd.·Product code MHX·2014-02-21
K133710 — LZI MULTIPLE ANALYTE SET A; B; C DRUGS OF ABUSE CONTROLSLin-Zhi International, Inc.·Product code DKB·2014-02-21
K133948 — BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENTBard Peripheral Vascular, Inc.·Product code KNW·2014-02-21
K131041 — ADVANCED PERFUSION SYSTEM 1Terumo Cardiovascular Systems Corp.·Product code DTQ·2014-02-20
K131145 — PROINSERTNidacon International AB·Product code MQK·2014-02-20
K131196 — INFANT PHOTOTHERAPY BILITRON SKY 5006Fanem Lda·Product code LBI·2014-02-20
K131772 — CANTATA(R) 2.9 MICROCATHETERCook, Inc.·Product code KRA·2014-02-20
K132321 — JMS SYRINGEJMS North America Corporation·Product code FMF·2014-02-20
K132949 — PELLEFIRMEllman International, Inc.·Product code PBX·2014-02-20
K133076 — NOVAGOLD HIGH PERFORMANCE GUIDEWIRENeometrics, Inc.·Product code OCY·2014-02-20
K133567 — UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEMGlobus Medical, Inc.·Product code KWQ·2014-02-20
K133585 — INBONE TOTAL ANKLEWrightmedicaltechnologyinc·Product code HSN·2014-02-20
K133617 — JAZZ SYSTEMImplanet, S.A.·Product code OWI·2014-02-20
K140160 — RELIEVA SCOUT SINUS DILATION SYSTEMAcclarent, Inc.·Product code LRC·2014-02-20
K132323 — RS-3000 ADVANCENidek Co., Ltd.·Product code OBO·2014-02-19
K132958 — MEDICINAL LEECHESNorth America BioPharma·Product code NRN·2014-02-19
K133564 — MODIFICATION TO NAUTILUS SPINAL SYSTEMLife Spine, LLC·Product code NKB·2014-02-19
K133845 — 8MM TROCAR KITIntuitive Surgical·Product code GCJ·2014-02-19
K140030 — DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYN·2014-02-19
K140170 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGECardica, Inc.·Product code GDW·2014-02-19
K140181 — MEDOS HILITE INFANT OXYGENATORMedos Medizintechnik AG·Product code DTZ·2014-02-19
K140214 — 30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6)Jvckenwood Corporation·Product code LLZ·2014-02-19
K130385 — COMPRESSIBLE LIMB SLEEVE SYSTEMMaxstar Industrial Co., Ltd.·Product code IRP·2014-02-18
K130800 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Kaixuan Plastic Co., Ltd.·Product code LYZ·2014-02-18
K130809 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Jewel Plastic Co., Ltd.·Product code LYZ·2014-02-18
K130891 — POWDER FREE VINYL PATIENT EXAMINATION GLOVESFriend Plastic Co., Ltd.·Product code LYZ·2014-02-18
K131898 — A SERIES AND Q SERIES PATIENT MONITORSGuangdong Biolight Meditech Co., Ltd.·Product code MWI·2014-02-18
K132451 — SARNS SOFT-FLOW AORTIC CANNULATerumo Cardiovascular Systems Corp.·Product code DWF·2014-02-18
K132953 — TIDISHEILDTidi Products,Llc·Product code PEM·2014-02-18
K133449 — KASM KNEE ARTICULATING SPACER MOLDSOrtho Development Corp.·Product code JWH·2014-02-18
K140177 — MEDOS HILITE OXYGENATORMedos Medizintechnik AG·Product code DTZ·2014-02-18
K130781 — L.A.M. IPM WOUND GEL, IPM DERM GELGlycobiosciences, Inc.·Product code FRO·2014-02-14
K131260 — NMI DIALYSIS CATHETERNavilyst Medical, Inc.·Product code MSD·2014-02-14
K131266 — TREZ_HDExcel-Tech Ltd. (Xltek)·Product code GWQ·2014-02-14
K132192 — BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATORBracco Diagnostic, Inc.·Product code FCX·2014-02-14
K132212 — DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONALHager& Meisinger GmbH·Product code DZL·2014-02-14
K132426 — SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPSSylphar N.V.·Product code LBH·2014-02-14
K132534 — VICTUS FEMTOSECOND LASER PLATFORMTechnolas Perfect Vision GmbH·Product code OOE·2014-02-14
K132649 — REVEAL LINQ INSERTABLE CARDIAC MONITORMedtronic, Inc.·Product code MXD·2014-02-14
K132909 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)Becton, Dickinson and Company·Product code LON·2014-02-14
K133242 — STELLARIS VISION ENHANCEMENT SYSTEMBausch & Lomb·Product code HQC·2014-02-14
K133296 — XCATHAlseal·Product code DYB·2014-02-14
K133335 — POWERPORT IMPLANTABLE PORTC.R. Bard, Inc.·Product code LJT·2014-02-14
K133450 — AIRSTRIP REMOTE PATIENT MONITORINGAirstrip Technologies, LP·Product code MWI·2014-02-14
K133629 — ANGIOJET ULTRA AVX THROMBECTOMY SETPossis Medical, Inc.·Product code QEW·2014-02-14
K133708 — MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITORNec Display Solutions , Ltd.·Product code LLZ·2014-02-14
K134004 — VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICECellco Partnership D/B/A Verizon Wireless·Product code DRG·2014-02-14

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