FDA 510(k) clearances — page 393

176,542 clearances on record, most recent first.

Clearances — page 393

39,201–39,300 of 176,542

K132988 — VITAL COUGHLung Assist, Inc.·Product code NHJ·2014-03-28
K133116 — VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTICConmed Corporation·Product code KCT·2014-03-28
K133170 — QUICK JET MMicron Corp.·Product code EFB·2014-03-28
K133174 — ORTHOSCAN FD MINI C-ARMOrthoscan, Inc.·Product code OXO·2014-03-28
K133210 — B&B BUBBLERS & T Medical Technologies, Inc.·Product code BYE·2014-03-28
K133344 — MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORSSebia·Product code LCP·2014-03-28
K133408 — NEUROSTAR TMS THERAPY SYSTEMNeuronetics·Product code OBP·2014-03-28
K133515 — PEEK FUSION IMPLANTMtp Solutions, LLC·Product code HWC·2014-03-28
K133540 — FLOCAPMaxtec, Inc.·Product code CCK·2014-03-28
K133560 — ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEMConformis, Inc.·Product code JWH·2014-03-28
K133636 — EXTREMITY MEDICAL HAMMERTOE DEVICEExtremity Medical, LLC·Product code HWC·2014-03-28
K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)Biomet UK, Ltd.·Product code HRY·2014-03-28
K133984 — CORONIS 5MPBarco N.V.·Product code LLZ·2014-03-28
K134016 — ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNERHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical·Product code IYN·2014-03-28
K140201 — AXERA 2 ACCESS SYSTEMArstasis, Inc.·Product code DYB·2014-03-28
K130603 — PATHFAST CTNL CALIBRATORSMitsubishi Chemical Medience Corporation·Product code JIT·2014-03-27
K132002 — SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTORRayner Intraocular Lenses , Ltd.·Product code MSS·2014-03-27
K132373 — BIOMET ACCESS SYSTEMBiomet Spine (Aka Ebi, LLC)·Product code PDQ·2014-03-27
K133004 — VENTED MILLEX -GV, CATHIVEX -GVMerck Millipore , Ltd.·Product code BSN·2014-03-27
K133455 — CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTICPioneer Surgical Technology, Inc.·Product code MAX·2014-03-27
K133493 — SINGLE USE STERILE SYRINGE WITH NEEDLEJiangxi Kelun Medical Devices Manufacturing Co.,Lt·Product code FMF·2014-03-27
K133631 — LEXIPLIANT DILATOR SHEATH SETSpectranetics Corporation·Product code DRE·2014-03-27
K133719 — PDE-NEOHamamatsu Photonics K.K.·Product code IZI·2014-03-27
K133930 — FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SETFlower Orthopedics Corporation·Product code HRS·2014-03-27
K140106 — S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMRenovis Surgical Technologies, Inc.·Product code OVD·2014-03-27
K140485 — MANDREL GUIDEWIRELake Region Medical·Product code DQX·2014-03-27
K140534 — ELECSYS PRECICONTROL TSRoche Diagnostics·Product code JJX·2014-03-27
K131760 — WHIP MIX PREPPIES PLUSWhip-Mix Corp.·Product code EJR·2014-03-26
K131939 — AMICO DH-W35 OPHTHALMOSCOPE SERIESAmico Diagnostic Incorporated·Product code HLI·2014-03-26
K132320 — INTELLIVUE CL RESPIRATION PODPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN·Product code BZQ·2014-03-26
K132759 — VENTRAINDolphys Medical B.V.·Product code BTL·2014-03-26
K133508 — RESOLUTIONMD MOBILECalgary Scientific, Inc.·Product code LLZ·2014-03-26
K133539 — TOTAL ACROSSMedtronic Vascular·Product code DQY·2014-03-26
K133544 — OP300Palodex Group OY·Product code OAS·2014-03-26
K133599 — CORGRIPCorpak Medsystems·Product code KNT·2014-03-26
K133680 — ENCORE SYSTEMSiesta Medical, Inc.·Product code ORY·2014-03-26
K133775 — EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKINGExciton Technologies, Inc.·Product code FRO·2014-03-26
K133807 — MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNITGambro Renal Products, Inc.·Product code FLD·2014-03-26
K140029 — AMIPLIVUE HSV 1&2 ASSAYQuidel Corporation·Product code OQO·2014-03-26
K140300 — COLLAGEN TENDON SHEET-DDI (CTS-DDI)Rotation Medical, Inc.·Product code OWY·2014-03-26
K140415 — MONOTEXRiverpoint Medical·Product code NBY·2014-03-26
K140637 — PEREGRINE SYSTEM INFUSION CATHETERAblative Solutions, Inc.·Product code KRA·2014-03-26
K131703 — NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEMNova Biomedical Corporation·Product code CHL·2014-03-25
K132017 — HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUITFisher & Paykel Healthcare, Ltd.·Product code BTT·2014-03-25
K132965 — SOLACE SOUND GENERATORSAmplisound Hearing Products & Services·Product code KLW·2014-03-25
K133640 — ASIR-VGe Medical Systems, LLC·Product code JAK·2014-03-25
K133663 — NIO COLOR 2MPBarco N.V.·Product code LLZ·2014-03-25
K133673 — ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMAMeridian Bioscience, Inc.·Product code OZZ·2014-03-25
K133972 — ASPIRE CRISTALLEFujifilm Medical Systems U.S.A, Inc.·Product code MUE·2014-03-25
K133993 — CAAS WORKSTATIONPie Medical Imaging·Product code IZI·2014-03-25
K140079 — SILEX SACROILIAC JOINT FUSION SYSTEMX-Spine Systems, Inc.·Product code OUR·2014-03-25
K140137 — SAFETY BIOPSY NEEDLE SYSTEMPfm Medical, Inc.·Product code FCG·2014-03-25
K140393 — RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3Randox Laboratories Limited·Product code JJY·2014-03-25
K140449 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek, Inc.·Product code NKB·2014-03-25
K140452 — VEGA KNEE SYSTEMAesculap Implant Systems·Product code JWH·2014-03-25
K140457 — NAUTILUS SPINAL SYSTEMLife Spine, Inc.·Product code NKB·2014-03-25
K130550 — RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREWEncore Medical L.P.·Product code PHX·2014-03-24
K132250 — INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEMIntegra LifeSciences Corporation·Product code JWJ·2014-03-24
K132656 — PRODENSE BONE GRAFT SUBSTITUTEWrightmedicaltechnologyinc·Product code MQV·2014-03-24
K133125 — WITHINGS BLOOD PRESURE MONITORWithings·Product code DXN·2014-03-24
K133232 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRESKci USA, Inc. (Kinetic Concepts, Inc.)·Product code OMP·2014-03-24
K133382 — QB TESTQbtech AB·Product code LQD·2014-03-24
K133453 — IOVERAMyoscience, Inc.·Product code GXH·2014-03-24
K133593 — T:SLIM INSULIN DELIVERY SYSTEMTandem Diabetes Care, Inc.·Product code LZG·2014-03-24
K133974 — VARIAX DISTAL RADIUS PLATING SYSTEMStryker Leibinger GmbH·Product code HRS·2014-03-24
DEN130049 — SIMPLEXA HSV 1&2 DIRECTFocus Diagnostics·Product code PGH·2014-03-21
K131553 — XTRASorin Group Deutschland GmbH·Product code CAC·2014-03-21
K131652 — LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLSLin-Zhi International, Inc.·Product code LAF·2014-03-21
K131877 — SAVE II, SAVE II BASICAutomedx, Inc.·Product code BTL·2014-03-21
K132011 — APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SETAea Srl·Product code FMF·2014-03-21
K132031 — AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROLAxis-Shield Poc AS·Product code CHH·2014-03-21
K132104 — ELIBRA SOFT-TISSUE FORCE SENSORKamm & Associates·Product code ONN·2014-03-21
K132144 — KERATORLK Consulting Group USA, Inc.·Product code DZE·2014-03-21
K132607 — NS 2500 HOLMIUM LASER SYSTEMNew Star Lasers, Inc.·Product code GEX·2014-03-21
K133657 — DISCOVERY PET/CT 710Ge Medical Systems, LLC·Product code KPS·2014-03-21
K133735 — EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSYung Sheng Optical Co., Ltd.·Product code LPL·2014-03-21
K133782 — NOVA FA DR SYSTEMSedecal., Sa.·Product code MQB·2014-03-21
K133786 — DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LIDDornoch Medical Systems, Inc.·Product code JCX·2014-03-21
K133944 — RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEMK2m, Inc.·Product code NKB·2014-03-21
K140524 — TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEMTeratech Corp.·Product code IYN·2014-03-21
K131971 — IM60/IM70 PATIENT MONITOREdan Instruments, Inc.·Product code MHX·2014-03-20
K132123 — TRC-PEX, RADIC-SEALERKm Corporation·Product code KIF·2014-03-20
K132436 — VARIOGUIDE DRILL KITMri Interventions, Inc.·Product code HBE·2014-03-20
K133073 — CAIR DRIVE, NEUTRACLEARCair Lgl·Product code FPA·2014-03-20
K133211 — ZIRTOUGHKuraray Noritake Dental, Inc.·Product code EIH·2014-03-20
K133231 — DIGORA OPTIMEInstrumentarium Dental, Palodex Group OY·Product code MUH·2014-03-20
K133319 — ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060Lumenis, Ltd.·Product code GEX·2014-03-20
K133398 — STRYKER PEDIATRIC MANDIBLE DISTRACTORStryker·Product code MQN·2014-03-20
K133529 — CAMBER SPINE COVERIS CERVICAL CAGECamber Spine·Product code ODP·2014-03-20
K133613 — INTRA-LOCK DENTAL IMPLANTSIntra-Lock International, Inc.·Product code DZE·2014-03-20
K133842 — TYBER MEDICAL TRAUMA SCREWTyber Medical, LLC·Product code HWC·2014-03-20
K133958 — FLOW-I ANESTHESIA SYSTEM C20, C30 & C40Maquet Critical Care AB·Product code BSZ·2014-03-20
K134038 — CAMBER SPINE DIAGON OBLIQUE CAGECamber Spine·Product code MAX·2014-03-20
K140253 — MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPESiemens Medical Solutions USA, Inc.·Product code LNH·2014-03-20
K140465 — VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINERVentana Medical Systems, Inc.·Product code NQN·2014-03-20
K132078 — METALLIC INTRAMEDULLARY NAIL SYSTEMTianjin Walkman Biomaterial Co., Ltd.·Product code HSB·2014-03-19
K132151 — SRS ENDOSCOPIC STAPLING SYSTEMMedigus , Ltd.·Product code ODE·2014-03-19
K132206 — MELYS ATRIAL FIBRILLATION SCREENING MONITORAdvanced Fluidics, LLC·Product code DXH·2014-03-19
K133144 — SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICECrossbay Medical, Inc.·Product code PGK·2014-03-19
K133217 — CIRRUS PHOTOCarl Zeiss Meditec, AG·Product code OBO·2014-03-19

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