FDA 510(k) clearances — page 409

176,542 clearances on record, most recent first.

Clearances — page 409

40,801–40,900 of 176,542

K132700 — PERIMETER INTERBODY FUSION DEVICEMedtronic Sofamor Danek, Inc.·Product code MAX·2013-09-26
K132701 — PRIMI SUPPORT CATHETERThermopeutix, Inc.·Product code DQY·2013-09-26
K132777 — NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETEREv3, Inc.·Product code LIT·2013-09-26
K121790 — ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEMBeckman Coulter, Inc.·Product code MMI·2013-09-25
K130455 — 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECESDentalez Group, Stardental Division·Product code EFB·2013-09-25
K130510 — ARTHREX COMPRESSION PLATESArthrex, Inc.·Product code HRS·2013-09-25
K131289 — I-GENMegagen Implant Co., Ltd.·Product code JEY·2013-09-25
K131440 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUEHebei Hongsen Plastics Technology Co, Ltd.·Product code LZA·2013-09-25
K131751 — FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVESLucenxia Prescience AG·Product code KGO·2013-09-25
K131873 — NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)MethodSense, Inc.·Product code LLZ·2013-09-25
K131891 — ECLIPSE TREATMENT PLANNING SYSTEMVarian Medical Systems, Inc.·Product code MUJ·2013-09-25
K131965 — XVI R5.0Elekta Limited·Product code IYE·2013-09-25
K131992 — MULTICHEM PTechno-Path Manufacturing , Ltd.·Product code JJY·2013-09-25
K132287 — JAZZ SYSTEMHogan Lovells US LLP·Product code OWI·2013-09-25
K132665 — PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IECEllman International, Inc.·Product code GEI·2013-09-25
K123402 — DIAGNOCAMKaltenbach & Voigt GmbH·Product code NTK·2013-09-24
K130654 — CRYSTAL ULTRADental Laboratory Milling Supplies, LLC (Dlms)·Product code EIH·2013-09-24
K131529 — SHENGGUANG MANUAL WHEELCHAIRPingdingshan Shenxing Healthcare Technology Co., L·Product code IOR·2013-09-24
K131685 — GE ECHOPACGe Vingmed Ultrasound AS·Product code LLZ·2013-09-24
K131773 — BRILLIANCE ICTPhilips Healthcare (Cleveland)·Product code JAK·2013-09-24
K131937 — VOLUSON I/EGE Healthcare·Product code IYN·2013-09-24
K132171 — AIXPLORERSupersonic Imagine·Product code IYN·2013-09-24
K132274 — AIXPLORERSupersonic Imagine·Product code IYN·2013-09-24
K130172 — BELIMED STEAM STERILIZER MST-VBelimed, Inc.·Product code FLE·2013-09-23
K130177 — ANATOMIC PEEK CERVICAL FUSION SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code ODP·2013-09-23
K130365 — X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINEREncore Medical L.P.·Product code OQG·2013-09-23
K131429 — RELIANCE CERVICAL IBF SYSTEMReliance Medical Systems, LLC·Product code ODP·2013-09-23
K131526 — SFI-BARCendres & Metaux SA·Product code NHA·2013-09-23
K131888 — T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICEMedtronic Sofamor Danek, Inc.·Product code MQP·2013-09-23
K132046 — PIPELINE KNEE SYSTEMPipeline Orthopedics·Product code JWH·2013-09-23
K132069 — DESARA MESH, DESARA BLUECaldera Medical, Inc.·Product code OTN·2013-09-23
K132508 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and Prevention·Product code OZE·2013-09-23
K132672 — EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTERDornier Medtech America·Product code LNS·2013-09-23
K132692 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+BBecton, Dickinson and Company·Product code PSZ·2013-09-23
K131177 — SINUFLUSH LAVAGE SYSTEMHedgepath, LLC·Product code KAR·2013-09-20
K131622 — MROZ REVERSE OSMOSIS SYSTEMAmeriwater·Product code FIP·2013-09-20
K131723 — COROENT SINGLE TAB SYSTEMNuvasive, Inc.·Product code OVD·2013-09-20
K132091 — MULTICHEM IA AND IA PLUSTechno-Path Manufacturing , Ltd.·Product code JJY·2013-09-20
K132174 — MULTICHEM WBTTechno-Path Manufacturing , Ltd.·Product code DIF·2013-09-20
K132203 — PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULALexion Medical, LLC·Product code HIF·2013-09-20
K132317 — MICROPLEX COIL SYSTEM (MCS), VFCMicroVention, Inc.·Product code HCG·2013-09-20
K132391 — IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIALSiemens Helathcare Diagnostics, Inc.·Product code JJX·2013-09-20
K122143 — VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINERVentana Medical Systems, Inc.·Product code NQN·2013-09-19
K124024 — APD LUER-LOCK ADAPTERFresensius Medical Care North America·Product code KDJ·2013-09-19
K130021 — PHILIPS HERCEPTEST DIGITAL SCOREPhilips Medical Systems Nederland B.V.·Product code OEO·2013-09-19
K130053 — BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BIBio-Rad Laboratories, Inc.·Product code MVM·2013-09-19
K130810 — ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEMZimmer, Inc.·Product code HWC·2013-09-19
K131354 — RENOVIS BIPOLAR HIP SYSTEMRenovis Surgical Technologies, LLC·Product code KWY·2013-09-19
K131375 — AUTOLAP SYSTEMMst - Medical Surgery Technologies , Ltd.·Product code GCJ·2013-09-19
K131903 — EQUINOX CO2 LASEREclipse Aesthetics, LLC·Product code ONG·2013-09-19
K132420 — WINGMAN EXTENDABLE TIP SUPPORT CATHETERReflow Medical·Product code DQY·2013-09-19
K132479 — OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00Interventional Spine, Inc.·Product code MAX·2013-09-19
K132513 — Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHERArthroCare Corporation·Product code MBI·2013-09-19
K132626 — PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)Pipeline Biotechnology·Product code LPH·2013-09-19
K132632 — TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLESTornier, Inc.·Product code MBI·2013-09-19
K132644 — LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BUCorentec Co., Ltd.·Product code MNI·2013-09-19
K122311 — GC-3000E DIGITAL COLPOSCOPEShenzhen Goldcare Meditech Co., Ltd.·Product code HEX·2013-09-18
K124025 — ALPHA-PRO WHITE VARNISHDental Technologies, Inc.·Product code LBH·2013-09-18
K130373 — NAVIOS FLOW CYTOMETER SYSTEMBeckman Coulter, Inc.·Product code OYE·2013-09-18
K130840 — SMARTBUILDER SYSTEM (SB1)Osstem Implant Co., Ltd.·Product code JEY·2013-09-18
K131122 — S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMRenovis Surgical Technologies, LLC·Product code OVD·2013-09-18
K131394 — TRANSTEK GLASS BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.·Product code MNW·2013-09-18
K132314 — MEDLINE ANTI-REFLUX VALVEMedline Industries, Inc.·Product code FEG·2013-09-18
K113738 — CREODENT SOLIDEX CUSTOM ABUTMENTCreodent Prosthetics, Ltd.·Product code NHA·2013-09-17
K121817 — VCARE AIVT Medical, Ltd.·Product code OMP·2013-09-17
K122711 — FACIAL SPANuskin·Product code NFO·2013-09-17
K123130 — ANSWATCH WRIST MONITOR MODEL TS-0411Taiwan Scientific Corporation·Product code DXN·2013-09-17
K130232 — ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARMJinxinbao Electronic Co.,Ltd·Product code DXN·2013-09-17
K130595 — ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAILZimmer, Inc.·Product code HSB·2013-09-17
K131114 — DIGITAL FLAT PANEL X-RAY DETECTORRayence Co., Ltd.·Product code MQB·2013-09-17
K131161 — EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,CIVCO Medical Instruments Co., Inc.·Product code ITX·2013-09-17
K131745 — BLOM-SINGER SEPTAL PERFORATION PROSTHESISHelix Medical, LLC·Product code LFB·2013-09-17
K131830 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMEdan Instruments, Inc.·Product code IYO·2013-09-17
K131977 — CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENTGE Healthcare·Product code LLZ·2013-09-17
K131988 — ABL90 FLEX ANALYZERRadiometer Medical Aps·Product code CHL·2013-09-17
K132164 — HEARTSPAN STEERABLE INTRODUCER KITMerit Medical Systems, Inc.·Product code DYB·2013-09-17
K132590 — 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TAArthroCare Corporation·Product code MBI·2013-09-17
K132591 — MAXLOCK EXTREME SYSTEMOrthohelix Surgical Designs, Inc.·Product code HRS·2013-09-17
K132593 — CRYSTALSERT DELIVERY SYSTEMBausch & Lomb·Product code MSS·2013-09-17
K123957 — PNEUPAC PARAPAC PLUSSmiths Medical International , Ltd.·Product code BTL·2013-09-16
K123991 — DEPUY CORAIL AMT HIP PROSTHESISDepuy France S.A.S.·Product code KWY·2013-09-16
K130760 — ELECTROSURGICAL GENERATORBeijing Jinhengwei Technology Development Co., Ltd.·Product code GEI·2013-09-16
K130802 — OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)Shenzhen Dongdixin Technology Co., Ltd.·Product code NUH·2013-09-16
K130996 — ERCHONIA EMERGEErchonia Medical, Inc.·Product code NHN·2013-09-16
K131398 — NOVOKNEE TOTAL KNEE SYSTEMNovosource, Inc.·Product code JWH·2013-09-16
K131494 — HEART SYNCHeart Sync, Inc.·Product code MKJ·2013-09-16
K132053 — RAMPART-O, RAMPART-TSpineology, Inc.·Product code MAX·2013-09-16
DEN130023 — UROLIFT SYSTEMNeotract, Inc.·Product code PEW·2013-09-13
K123866 — TANYXMedecell Us, Inc.·Product code NUH·2013-09-13
K123902 — PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLC·Product code IKN·2013-09-13
K124026 — LOBSTER AUTO-INJECTORScandinavian Health Limited·Product code KZH·2013-09-13
K124031 — DA VINCI FLUORESCENCE IMAGING VISION SYSTEMIntuitive Surgical, Inc.·Product code OWN·2013-09-13
K130641 — LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICEBinder Biomedical, Inc.·Product code OVD·2013-09-13
K130873 — VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07MVital Access·Product code PFH·2013-09-13
K131059 — PIONEER ELITE DIODE LASERCAO Group, Inc.·Product code GEX·2013-09-13
K131084 — SASMAR ORIGINAL, SASMAR CLASSICSasmar, Inc.·Product code NUC·2013-09-13
K131409 — CAS PSI KNEE SYSTEMOrthosoft, Inc.·Product code JWH·2013-09-13
K131508 — VYSIS D7S486/CEP 7 FISH PROBE KITAbbott Molecular, Inc.·Product code PFG·2013-09-13
K131854 — CEROXOr-Nim Medical , Ltd.·Product code DPW·2013-09-13
K132175 — EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETEREdwards Lifesciences, LLC·Product code DXC·2013-09-13

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