FDA 510(k) clearances — page 397

176,542 clearances on record, most recent first.

Clearances — page 397

39,601–39,700 of 176,542

K140103 — 3MP GRAYSCAKE LCD DISPLAYShenzhen Beacon Display Technology Co., Ltd.·Product code LLZ·2014-02-14
K140108 — 3MP COLOR LCD DISPLAYShenzhen Beacon Display Technology Co., Ltd.·Product code LLZ·2014-02-14
K140136 — NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICENipro Medical Corporation·Product code FOZ·2014-02-14
K130633 — INTRODUCER SETS, MODEL ADELANTE RADIALOscor, Inc.·Product code DYB·2014-02-13
K132257 — MANUAL WHEELCHAIRZhejiang Jiafeng Electrical & Mechanial Co., Ltd.·Product code IOR·2014-02-13
K132422 — PALS PLATINUM NEUROSTIMULATION ELECTRODESAxelgaard Mfg. Co., Ltd.·Product code GXY·2014-02-13
K132832 — ACTIVAPATCH ET IONTOPHORESIS PATCHActivatek, Inc.·Product code EGJ·2014-02-13
K140104 — BARRICADE EMBOLIZATION COIL SYSTEMBlockade Medical·Product code HCG·2014-02-13
K122758 — POWERHEART G5 AEDCardiac Science Corporation·Product code MKJ·2014-02-12
K123537 — POWDER FREE LATEX EXAMINATION GLOVESQube Medical Product Sdn Bhd·Product code LYY·2014-02-12
K130040 — MEPITEL AGMolnlycke Health Care·Product code FRO·2014-02-12
K130930 — OWL CONTACT LENS CASES, DOG CONTACT LENS CASESNingbo Lishunda Electronics Co., Ltd.·Product code LRX·2014-02-12
K131033 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Decent Plastic Co., Ltd.·Product code LYZ·2014-02-12
K131154 — ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SETZevex, Inc.·Product code LZH·2014-02-12
K131454 — KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEADTotal Joint Orthopedics, Inc.·Product code LPH·2014-02-12
K131552 — CONVENTUS DRSConventus Orthopaedics·Product code HRS·2014-02-12
K131882 — GEODESICEEG SYSTEM 400 SERIES (GES 400)Electrical Geodesics, Inc.·Product code OLT·2014-02-12
K132424 — METRIXCAREThe Metrix Company·Product code KNT·2014-02-12
K132464 — PTFE SURGICAL SUTUREOmnia Spa·Product code NBY·2014-02-12
K132582 — EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEMExactech, Inc.·Product code OVE·2014-02-12
K132720 — HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATHMerit Medical Systems, Inc.·Product code DYB·2014-02-12
K132991 — C-BOX PEEK CERVICAL IBFInnovasis, Inc.·Product code ODP·2014-02-12
K133201 — SHASER V-MINI 2 HAIR REMOVAL SYSTEMShaser, Inc.·Product code ONF·2014-02-12
K133273 — LIGER MEDICAL ESU-110Liger Medical, LLC·Product code GEI·2014-02-12
K133274 — VENA PROInnovamed Health, LLC·Product code JOW·2014-02-12
K133293 — 15 FR. TANDEMHEART ARTERIAL CANNULACardiacassist, Inc.·Product code DWF·2014-02-12
K133352 — HYPERSOUND AUDIO SYSTEM (HSS)Hypersound Health, Inc.·Product code EPF·2014-02-12
K133476 — SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTIONCarl Zeiss Meditec, AG·Product code HJO·2014-02-12
K133526 — MDIXON-QUANTPhilips Medical Systems Nederland B.V.·Product code LNH·2014-02-12
K133533 — LOGIQ EGE Healthcare·Product code IYN·2014-02-12
K140102 — PHYSIOFLOW Q-LINKVasocom, Inc.·Product code DSB·2014-02-12
K140116 — RESTORELLE Y CONTOUR MESHColoplast A/S·Product code OTO·2014-02-12
K122632 — GUAVA IICardiocomm Solutions, Inc.·Product code DPS·2014-02-11
K130485 — CONTROL SEALVoco GmbH·Product code EBC·2014-02-11
K132472 — JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOADJustright Surgical, LLC·Product code GDW·2014-02-11
K132583 — EZ-IO INTRAOSSEOUS INFUSION SYSTEMVidacare Corporation·Product code FMI·2014-02-11
K132925 — SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINKAmendia, Inc.·Product code NKB·2014-02-11
K133267 — DANA REUSABLE TEST PACKDana Products, Inc.·Product code FRC·2014-02-11
K133318 — ADHESE UNIVERSALIvoclar Vivadent, AG·Product code KLE·2014-02-11
K133359 — ENDORINGSEndo-Aid, Inc.·Product code FED·2014-02-11
K133607 — V8 TRANSLUMINAL BAV CATHETERIntervalve, Inc.·Product code OZT·2014-02-11
K140063 — EQUINOXE EXTRA SHORT HUMERAL HEADExactech, Inc.·Product code KWS·2014-02-11
K140117 — AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTYOrthocon, Inc.·Product code MTJ·2014-02-11
K130511 — CITRISOL ACID CONCENTRATEDiasol, Inc.·Product code KPO·2014-02-10
K130991 — NEXXZR(TM)T AND NEXXZR(TM)SSagemax Bioceramics, Inc.·Product code EIH·2014-02-10
K131146 — ARTASSIST AND VENASSISTAci Medical, LLC·Product code JOW·2014-02-10
K133477 — TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESISSynchro Medical·Product code HTY·2014-02-10
K133497 — AQUILION ONE VISIONToshibamedical Systems Corporation·Product code JAK·2014-02-10
K133583 — OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070Interventional Spine, Inc.·Product code MAX·2014-02-10
K133623 — C-PLUSPioneer Surgical Technology, Inc.·Product code ODP·2014-02-10
K133692 — IMRI 1.5T AND IMRI 3T SImris, Inc.·Product code LNH·2014-02-10
K123880 — QUANTA FLASH CENTROMEREInova Diagnostics, Inc.·Product code LJM·2014-02-07
K130401 — ALERTWATCH: ORAlertwatch, LLC·Product code MHX·2014-02-07
K130616 — MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLESBiopsybell S.R.L.·Product code KNW·2014-02-07
K130723 — FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINALFamidoc Technology Co., Ltd.·Product code NGX·2014-02-07
K130807 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Hope Plastic Co., Ltd.·Product code LYZ·2014-02-07
K131966 — TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEMTwin Star Medical, Inc.·Product code LXC·2014-02-07
K132050 — NB3D BONE VOID FILLERPioneer Surgical Technology, Inc.·Product code MQV·2014-02-07
K132539 — RING-LOK MODULAR BIPOLAR SYSTEMImplants International, Ltd.·Product code KWY·2014-02-07
K132650 — SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEMHuntleigh Healthcare Limited·Product code HGM·2014-02-07
K133247 — ECLIPSE TREATMENT PLANNING SYSTEMVarian Medical Systems, Inc.·Product code MUJ·2014-02-07
K133263 — PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)Proteus Digital Health, Inc.·Product code OZW·2014-02-07
K133462 — DUOCENTRIC REVERSED SHOULDER PROSTHESISAston Medical·Product code KWS·2014-02-07
K133552 — MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KITHansen Medical·Product code DRA·2014-02-07
K130249 — INTEGRITY SPINAL CARE SYSTEM 3.0Integrity Life Sciences·Product code ITH·2014-02-06
K130864 — C-MAX+ (PLUS)Aat Alber Antriebstechnik GmbH·Product code ILK·2014-02-06
K130890 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Air Plastic Co., Ltd.·Product code LYZ·2014-02-06
K130921 — ALIVECOR HEART MONITOR OTCAliveCor, Inc.·Product code DPS·2014-02-06
K131341 — POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVESShijiazhuang Winful Plastic Co., Ltd.·Product code LYZ·2014-02-06
K132813 — DUAL ENERGY SYSTEM PACKAGEToshibamedical Systems Corporation·Product code JAK·2014-02-06
K132824 — CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATIONCarestream Health, Inc.·Product code LLZ·2014-02-06
K132839 — FUSE 1C COLONOSCOPY SYSTEMEndochoice, Inc.·Product code FDF·2014-02-06
K133394 — AIRSTRIP REMOTE PATIENT MONITORINGAirstrip Technologies, LP·Product code MWI·2014-02-06
K133396 — VDRIVE WITH V-SONOStereotaxis, Inc.·Product code DQX·2014-02-06
K133523 — STAPIX SUPERELASTIC IMPLANT BONE STAPLESInstratek, Inc.·Product code JDR·2014-02-06
K133701 — NUVANT MCT SYSTEMCorventis, Inc.·Product code QYX·2014-02-06
K140036 — APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITHAptus Endosystems, Inc.·Product code OTD·2014-02-06
K132613 — SONILASE LIGHT THERAPY DEVICEBiorenew Labs, LLC·Product code OHS·2014-02-05
K133550 — VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KITMaine Standards Company, LLC·Product code JJX·2014-02-05
K133601 — ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAYSiemens Healthcare Diagnostics, Inc.·Product code CEW·2014-02-05
K133666 — RT016 INSPIRATORY FILTERFisher & Paykel Healthcare, Ltd.·Product code CAH·2014-02-05
K133867 — SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)Terumo Europe N.V.·Product code FPA·2014-02-05
K140015 — CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCERCardiosolutions, Inc.·Product code DYB·2014-02-05
K130320 — BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWCovidien·Product code DQA·2014-02-04
K130582 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Heze City Green Food Co., Ltd.·Product code LYZ·2014-02-04
K131653 — LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLSLin-Zhi International, Inc.·Product code DKZ·2014-02-04
K132140 — DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETERDuteck Industrial Co., Ltd.·Product code FLL·2014-02-04
K132383 — GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETERGyrus Acmi, Inc.·Product code LJE·2014-02-04
K132602 — STREAMLINE EXPRESSNxstage Medical, Inc.·Product code KDI·2014-02-04
K132886 — SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEMSmith & Nephew, Inc.·Product code HRS·2014-02-04
K133737 — ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSIONZimmer, Inc.·Product code JWH·2014-02-04
K133757 — GFS II STANDARD, GFS II LARGE, GFS MIMIParcus Medical, LLC·Product code MBI·2014-02-04
K133794 — 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3Depuy Mitek, A Johnson & Johnson Company·Product code MAI·2014-02-04
K123475 — SHOOCIN INTRODUCER KITLepu Medical Technology (Beijing) Co., Ltd.·Product code DYB·2014-02-03
K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIESI-Flow, LLC·Product code MEB·2014-02-03
K131292 — DEROYAL SPINE SPACER SYSTEMDeroyal Industries, Inc.·Product code MAX·2014-02-03
K132767 — MEDLINE SHARPS CONTAINERMedline Industries, Inc.·Product code MMK·2014-02-03
K133151 — SARNS HIGH FLOW AORTIC ARCH CANNULATerumo Cardiovascular Systems Corp.·Product code DWF·2014-02-03
K133557 — JULIET LL LATERAL LUMBAR CAGESpineart·Product code MAX·2014-02-03
K130003 — XIRALITE FLOURESCENCE IMAGING SYSTEM X4Mivenion GmbH·Product code IZI·2014-01-31

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