FDA 510(k) clearances — page 420

176,542 clearances on record, most recent first.

Clearances — page 420

41,901–42,000 of 176,542

K131107 — ATRICLIP GILLINOV-COSGROVE LAA CLIPAtriCure, Inc.·Product code FZP·2013-05-14
K120756 — LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LEThe Lagado Corp.·Product code LPL·2013-05-13
K122013 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M)Microlife Corp.·Product code DXN·2013-05-13
K122635 — TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHORTornier, Inc.·Product code MAI·2013-05-13
K123629 — FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVESLucenxia Prescience AG·Product code KGO·2013-05-13
K123903 — BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)Becton, Dickinson & CO·Product code MDB·2013-05-13
K123913 — LATIS SPACERGlobus Medical, Inc.·Product code MAX·2013-05-13
K124058 — CREO STABILIZATION SYSTEMGlobus Medical, Inc.·Product code OSH·2013-05-13
K130159 — QLAB QUANTIFICATION SOFTWARE HEART MODELPhilips Health Care·Product code LLZ·2013-05-13
K130282 — REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENTRemington Medical, Inc.·Product code KNW·2013-05-13
K130506 — IMSE P-TLIFInstitute of Musculoskeletal Science & Education·Product code MAX·2013-05-13
K131099 — AG MASSHospitech Respiration , Ltd.·Product code JCX·2013-05-13
K121203 — BOSTON KERATOPROSTHESIS OR BOSTON KPROMassachusetts Eye & Ear Infirmary·Product code HQM·2013-05-10
K121467 — EUROTROL HEMATOCRIT CONTROLEurotrol B.V.·Product code GLK·2013-05-10
K121719 — SM TENS & PMSHong Qiangxing (Shenzhen) Electronics Limited·Product code NGX·2013-05-10
K123381 — HYPERION X9Cefla S.C.·Product code OAS·2013-05-10
K123478 — STINGRAY BIPOLAR FORCEPSStingray Surgical Products·Product code GEI·2013-05-10
K123769 — ZX-I POWER ADD ONSpinergy, Inc.·Product code ITI·2013-05-10
K123871 — FINGERTIP PULSE OXIMETERBeijing Choice Electronic Technololgy Co., Ltd.·Product code DQA·2013-05-10
K130192 — NEXTSTEP RETROGRADEArrow International, Inc.·Product code MSD·2013-05-10
K130289 — TRC-NW8 NON-MYDRIATIC RETINAL CAMERATopcon Corp.·Product code HKI·2013-05-10
K130617 — RAYSTATIONRaysearch Laboratories AB·Product code MUJ·2013-05-10
DEN120022 — X-RAY ATTENUATING CREAMBloxr Corporation·Product code PDK·2013-05-09
K122774 — SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175Sakura Seiki Co., Ltd.·Product code FLE·2013-05-09
K123581 — NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIENCovidien, Formerly Nellcor Puritan Bennett, Inc.·Product code DQA·2013-05-09
K123710 — UNITOX BOTOX SYRINGEBio-Med USA, Inc.·Product code FMF·2013-05-09
K130661 — ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEMZimmer, Inc.·Product code PHX·2013-05-09
K130796 — VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORMCovidien·Product code MWI·2013-05-09
K130830 — INTEGRA LAMINOPLASTY SYSTEMSeaspine, Inc.·Product code NQW·2013-05-09
K130990 — VARIANT(TM) II TURBO HBA1C KIT - 2.0Bio-Rad Laboratories, Inc., Clinical Systems Divis·Product code LCP·2013-05-09
K131020 — TEMPERATURE SENSOR CATHETERDegania Silicone , Ltd.·Product code EZL·2013-05-09
K131030 — RANGE SPINAL SYSTEMK2m, Inc.·Product code OSH·2013-05-09
K131038 — NMI PICC MAXIMAL BARRIER NURSING KITSNavilyst Medical, Inc.·Product code LJS·2013-05-09
K122877 — RANGE SPINAL SYSTEM, SMALL STATUREK2m, Inc.·Product code OSH·2013-05-08
K123079 — OLYMPIC BRAINZ MONITORExcel-Tech Ltd. (Xltek)·Product code OMA·2013-05-08
K123095 — MEDLINE BLOOD PRESSURE TRANSDUCERMedline Industries, Inc.·Product code DRS·2013-05-08
K123684 — SOL-CARE SAFETY NEEDLESol-Millennium Medical·Product code FMI·2013-05-08
K130513 — VOLISTA 400; VOLISTA 600Maquet S.A.S.·Product code FTD·2013-05-08
K130655 — RESPONSE SPINE SYSTEMOrthoPediatrics Corp.·Product code OSH·2013-05-08
K130763 — BEACON TISSUE MARKERScion Medical Technologies, LLC·Product code NEU·2013-05-08
K130964 — GRIDLOCK PLATING SYSTEMTrilliant Surgical, Ltd.·Product code HRS·2013-05-08
K120590 — DILATOR TUBE SETKoros USA, Inc.·Product code PDQ·2013-05-07
K122064 — FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICETianjin New Bay Bioresearch Co., Ltd.·Product code DJG·2013-05-07
K122343 — PUREFLUX-H HEMODIALYZERNipro Medical Corporation·Product code KDI·2013-05-07
K122707 — HOVERROUND TEKNIQUEHoveround Corp.·Product code ITI·2013-05-07
K122741 — HOVEROUND TEKNIQUEHoveround Corp.·Product code ITI·2013-05-07
K122923 — QUANTA FLASH ENA7Inova Diagnostics, Inc.·Product code LLL·2013-05-07
K123368 — LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANTHartalega Sdn Bhd·Product code LYY·2013-05-07
K123748 — ABL90 FLEXRadiometer Medical Aps·Product code CHL·2013-05-07
K130326 — TEPHAFLEX MELTBLOWN CONSTRUCTTepha, Inc.·Product code OOD·2013-05-07
K130494 — UNITRON TINNITUS MASKER FEATUREUnitron Hearing·Product code KLW·2013-05-07
K130624 — CONIGlobalmed·Product code LLZ·2013-05-07
K130825 — AZURE ANTERIOR CERVICAL PLATE SYSTEMOrthofix, Inc.·Product code KWQ·2013-05-07
K131009 — PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)Proteus Digital Health, Inc.·Product code OZW·2013-05-07
K121702 — ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICEOrthocor Medical·Product code ILX·2013-05-06
K122404 — MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26Repro-Med Systems, Inc. Dba Rms Medical Products·Product code FPA·2013-05-06
K124016 — EMPI PHOENIXDjo, LLC·Product code IPF·2013-05-06
K130963 — LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAKBio-Rad Laboratories, Inc.·Product code JJY·2013-05-06
K113539 — REVOIS PRO IMPLANT STSYEMRiemser Arzneimittel AG·Product code DZE·2013-05-03
K120597 — KOMPREDACustom Spine, Inc.·Product code MRW·2013-05-03
K121243 — ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETERMEDA Co., Ltd.·Product code IYO·2013-05-03
K121404 — SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEMOnset Medical Corporation·Product code DYB·2013-05-03
K122416 — ARTIGLASS L. O.R. GLASS SYRINGEArtiglass Srl·Product code FMF·2013-05-03
K122500 — NEO PS KNEE SYSTEMPipeline Orthopedics·Product code JWH·2013-05-03
K122559 — BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTSBiodenta Swiss AG·Product code NHA·2013-05-03
K122721 — AG GUFFILLHospitech Respiration , Ltd.·Product code BSK·2013-05-03
K123159 — SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTSSmith & Nephew, Inc.·Product code JWH·2013-05-03
K123486 — TRIATHLON TRITANIUM TIBIAL BASEPLATEStryker·Product code MBH·2013-05-03
K123600 — DIGITAL BLOOD PRESSURE MONITORLittle Doctor Electronic (Nantong)Co.,Ltd·Product code DXN·2013-05-03
K123926 — METASURG NITINOL STAPLE IMPLANTMetasurg·Product code JDR·2013-05-03
K130084 — MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGMTgm Medical, Inc.·Product code JWH·2013-05-03
K130147 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)Small Bone Innovations, Inc.·Product code HSB·2013-05-03
K130250 — QYAG LASER SYSTEMPalomar Medical Technologies, Inc.·Product code GEX·2013-05-03
K130334 — HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)Stryker Trauma AG·Product code KTT·2013-05-03
K130458 — KNOTLESS FIBERTAK SUTURE ANCHORArthrex, Inc.·Product code MBI·2013-05-03
K130594 — ENSITE VELOCITY SYSTEMSt Jude Medical·Product code DQK·2013-05-03
K130632 — STERISPINE PS PEDICLE SCREWSafe Orthopaedics·Product code NKB·2013-05-03
K130786 — SLEEK OTW PTA CATHETERC.R. Bard, Inc.·Product code LIT·2013-05-03
K120532 — GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEMGetinge Sourcing, LLC·Product code PEC·2013-05-02
K122196 — CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILYBlackrock Neuromed, LLC·Product code GWQ·2013-05-02
K122368 — WATERLASE IPLUS ALL TISSUE LASERBiolase Technology, Inc.·Product code GEX·2013-05-02
K122388 — SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514Seca GmbH & Co. KG·Product code MNW·2013-05-02
K122525 — SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEMBiotest Medical Corp.·Product code NBW·2013-05-02
K123500 — AQUILION LB TRITON V4.91Toshibamedical Systems Corporation·Product code JAK·2013-05-02
K123953 — ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann Diagnostic Technologies, Inc.·Product code KHS·2013-05-02
K123971 — CYNOSURE 1064NM DIODE LASERCynosure, Inc.·Product code ILY·2013-05-02
K130039 — REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZERGambro Renal Products, Inc.·Product code KDI·2013-05-02
K130174 — DVTCARE CA5Ossur Americas, Inc.·Product code JOW·2013-05-02
K130330 — RANGE SPINAL SYSTEMK2m, Inc.·Product code OSH·2013-05-02
K130346 — SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSIONNatus Neurology Incorporated·Product code GWF·2013-05-02
K130591 — SUPERA VERITASIdev Technologies, Inc.·Product code FGE·2013-05-02
K130605 — INOMAX DSIR (DELIVERY SYSTEM)Ino Therapeutics·Product code MRN·2013-05-02
K130811 — PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINEPsychemedics Corp.·Product code DKZ·2013-05-02
K130870 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)Hitachi Chemical Diagnostics, Inc.·Product code CIC·2013-05-02
K121401 — TENDER TOUCHSometech Corporation·Product code ILY·2013-05-01
K121613 — AGILIA INFUSION SYSTEMFresenius Kabi AG·Product code FRN·2013-05-01
K122347 — ELISIO-H AND ELISIO-M HEMODIALYZERSNipro Medical Corporation·Product code KDI·2013-05-01
K122595 — HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAMDermal Life, LLC·Product code FRO·2013-05-01
K123550 — UTF STEM, REDUCEDUnited Orthopedic Corporation·Product code LPH·2013-05-01
K123636 — H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICEBioness, Inc.·Product code GZI·2013-05-01

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