FDA 510(k) clearances — page 456

176,542 clearances on record, most recent first.

Clearances — page 456

45,501–45,600 of 176,542

K113798 — INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SETDraeger Medical Systems, Inc.·Product code MHX·2012-03-22
K102900 — HEITER 3000 HYPERTHERMIC PERFUSION SYSTEMHei, Inc.·Product code LGZ·2012-03-21
K112005 — NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)Ug Healthcare (Usa), Inc.·Product code LYY·2012-03-21
K112012 — NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVESUg Healthcare (Usa), Inc.·Product code LZA·2012-03-21
K112432 — ZOLL X SERIESZoll Medical Corporation, World Wide Headquarters·Product code MKJ·2012-03-21
K112887 — UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTORUpstream Peripheral Technologies·Product code DYB·2012-03-21
K113357 — POSEY BEDJ. T. Posey Co.·Product code OYS·2012-03-21
K113818 — EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILLPulpdent Corporation·Product code EBC·2012-03-21
K113865 — PULTOLSharp Corporation·Product code DQA·2012-03-21
K120070 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMSynthes USA·Product code HRS·2012-03-21
K120154 — INTRAUTERINE INSEMINATION (IUI) CATHETERCatheter Research, Inc.·Product code MQF·2012-03-21
K103623 — NEWDEAL INTERPHALANGEAL IMPLANTNewdeal Sas·Product code HTY·2012-03-20
K111756 — V1 SYSTEMOlympus Medical Systems Corp.·Product code FDF·2012-03-20
K112100 — M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETERVascular Solutions, Inc.·Product code DQY·2012-03-20
K112411 — MAMMOTOME ELITE BIOPSY SYSTEMDevicor Medical Products, Inc.·Product code KNW·2012-03-20
K113122 — PIPELINE CR PRIMARY KNEE SYSTEMPipeline Orthopedics·Product code JWH·2012-03-20
K113475 — ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEMEndoscopic Technologies, Inc. D/B/A Estech·Product code OCL·2012-03-20
K120363 — SYNGO RT INTERFACESiemens Medical Solutions USA, Inc.·Product code MUJ·2012-03-20
K120540 — BIOBOLTArthrex, Inc.·Product code MAI·2012-03-20
K110536 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVESZibo Tengyue Plastic Products Co., Ltd.·Product code LYZ·2012-03-19
K112078 — ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)Maruchi·Product code KIF·2012-03-19
K112268 — CODAN SAFEFEED ENTERAL FEEDING RESERVOIRCodan US Corp.·Product code KNT·2012-03-19
K112392 — HIVOX BIOTEK INC.Hivox Biotek, Inc.·Product code NUH·2012-03-19
K112682 — METHA HIP SYSTEMAesculap Implant Systems, LLC·Product code LZO·2012-03-19
K113618 — CLEARCORRECT SYSTEMClearcorrect, Inc.·Product code NXC·2012-03-19
K113808 — THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)C.R. Bard, Inc.·Product code LJS·2012-03-19
K113854 — PLEURX PERITONEAL CATHETER SYSTEMCare Fusion·Product code PNG·2012-03-19
K120197 — ABL90 FLEXRadiometer Medical Aps·Product code CHL·2012-03-19
K120453 — FILTEK BULK FILL FLOWABLE RESTORATIVE3M Espe Dental Products·Product code EBF·2012-03-19
K120544 — RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMENSt Jude Medical·Product code DRF·2012-03-19
K120557 — SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35Biomet Spine & Bone Healing Technologies·Product code OVD·2012-03-19
K110337 — UNIVERSAL MAXILLARY MOLAROco Biomedical·Product code DZE·2012-03-16
K111541 — ENDO-EXPRESS (R) HANDPIECEEssential Dental Systems, Inc.·Product code EGS·2012-03-16
K112154 — FEMTO LDVSie Ag,Surgical Instument Engineering·Product code HQF·2012-03-16
K112718 — NUVASIVE NVM5 SYSTEMNuvasive, Inc.·Product code ETN·2012-03-16
K113239 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)Health & Life Co., Ltd.·Product code DXN·2012-03-16
K113320 — NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12Exactech, Inc.·Product code MEH·2012-03-16
K113420 — RNARETAINAsuragen, Inc.·Product code OZF·2012-03-16
K113474 — 1.5T GEM FLEX COILNeocoil, LLC·Product code MOS·2012-03-16
K113515 — HORIZON CARDIOLOGY ECG MANAGEMENTMckesson Israel , Ltd.·Product code DQK·2012-03-16
K113558 — BD BACTEC Plus Aerobic/F Culture Vials (plastic)Becton, Dickinson and Company·Product code MDB·2012-03-16
K113763 — SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRENobles Medical Technologies Ii, Inc.·Product code GAW·2012-03-16
K113766 — CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRANVarian Medical Systems, Inc.·Product code JAQ·2012-03-16
K113788 — DEFLEX ACRILATONuxen S.R.L.·Product code EBI·2012-03-16
K113811 — V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEMC.R. Bard Inc., Bard Electrophysiology Division·Product code DQK·2012-03-16
K120031 — CHESAPEAKE SPINAL SYSTEMK2m, Inc.·Product code OVD·2012-03-16
K120060 — E-CUBE 9Alpinion Medical Systems Co., Ltd.·Product code IYN·2012-03-16
K120188 — ELECTROCARDIOGRAPHEdan Instruments, Inc.·Product code DPS·2012-03-16
K120373 — INSORB ABSORBALBE STAPLEIncisive Surgical, Inc.·Product code GDW·2012-03-16
K120480 — GORE(R) EMBOLIC FILTERW.L. Gore & Associates·Product code NTE·2012-03-16
K120485 — NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT PNihon Kohden America, Inc.·Product code OMA·2012-03-16
K111933 — COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0Covidien·Product code BZQ·2012-03-15
K112052 — CAREFUSION NICOLET EDXCarefusion 209, Inc.·Product code GWF·2012-03-15
K112404 — CONCENTRIC BALLOON GUIDE CATHETERConcentric Medical, Inc.·Product code DQY·2012-03-15
K112998 — AUTOPULSE RESUSCITATION SYSTEM MODEL 1000Zoll Circulation·Product code DRM·2012-03-15
K113090 — LEVEEN SUPERSLIM NEEDLE ELECTRODEBoston Scientific Corporation·Product code GEI·2012-03-15
K113387 — CITIEFFE TITANIUM NAILING SYSTEMCitieffe·Product code HSB·2012-03-15
K113712 — IM-11 PNEUMATIC MICROINJECTORNarishige Co., Ltd.·Product code MQJ·2012-03-15
K113749 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLORFull Synergy Medical Products, Inc.·Product code LYZ·2012-03-15
K113777 — QUIDEL MOLECULAR INFLUENZA A+BQuidel Corp.·Product code OZE·2012-03-15
K113791 — B-GENIN, R-GENINBerkeley Advanced Biomaterials, Inc.·Product code MQV·2012-03-15
K120120 — AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATHAga Medical Corporation·Product code DQY·2012-03-15
K120608 — ENDOSCOPIC APPLICATORMicromedics, Inc.·Product code GCJ·2012-03-15
K120660 — CONQUEST 40 PTA DILATATION CATHETERBard Peripheral Vascular, Inc.·Product code LIT·2012-03-15
K120677 — CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)Trireme Medical, Inc.·Product code LIT·2012-03-15
K102189 — POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIMLatexx Manufacturing Sdn.Bhd.·Product code LZC·2012-03-14
K111820 — SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGEBm Korea Co., Ltd.·Product code ODP·2012-03-14
K112902 — ENFLOW IV FLUID WARMERVital Signs, Inc.·Product code LGZ·2012-03-14
K112969 — AIR-BAG SYSTEMNiigata Mechatronics Co., Ltd.·Product code LHN·2012-03-14
K113700 — VIAVALVE SAFETY IV CATHETERSmiths Medical Asd, Inc.·Product code FOZ·2012-03-14
K113756 — HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PAEncore Medical L.P.·Product code OIY·2012-03-14
K120074 — FOUNDATION SPINAL SYSTEMThe Skeletal Design Partnership , Ltd.·Product code NKB·2012-03-14
K120115 — ORTHOSIZEOrthosize, LLC·Product code LLZ·2012-03-14
K120439 — BIOPLEX 2200 EBV IGG AND SYPHILIS IGGBio-Rad Laboratories, Inc.·Product code LIP·2012-03-14
K103116 — AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEMBestgen Biotech Corp.·Product code CGA·2012-03-13
K103329 — DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTIONDelbio Incorporation·Product code NBW·2012-03-13
K111523 — OSTEOCOOL (TM) RF ABLATION SYSTEMBaylis Medical Co., Inc.·Product code GEI·2012-03-13
K112144 — AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESISTornier·Product code PHX·2012-03-13
K112561 — NUVASIVE COROENT NO-PROFILE SYSTEMNuvasive, Inc.·Product code OVD·2012-03-13
K112648 — ASFORA BULLET CAGEMedical Designs, LLC·Product code MAX·2012-03-13
K113157 — AILERON INTERSPINOUS FIXATION SYSTEMLife Spine·Product code MNI·2012-03-13
K113354 — VETA PERITONEAL DIALYSIS CATHETERPfm Medical, Inc.·Product code FJS·2012-03-13
K113688 — MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEMBiolitec Medical Devices, Inc.·Product code GEX·2012-03-13
K110662 — ADAPTIVE WEDGEAdaptive Specialty, LLC·Product code HRS·2012-03-12
K111663 — TRAUMA INTERNAL FIXATION SYSTEMSDePuy Orthopaedics, Inc.·Product code HRS·2012-03-12
K112663 — ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERALEnhatch Orthopaedics, LLC·Product code HRS·2012-03-12
K112757 — PIONEER POSTERIOR CERVICO THORACIC SYSTEMPioneer Surgical Technology, Inc.·Product code KWP·2012-03-12
K113429 — SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTERNipro Medical Corporation·Product code FOZ·2012-03-12
K113540 — RELIANCE LUMBAR IBF SYSTEMReliance Medical Systems, LLC·Product code MAX·2012-03-12
K113624 — WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TESTGuangzhou Wondfo Biotech Co., Ltd.·Product code DJG·2012-03-12
K113838 — WILDCAT CATHETERAvinger, Inc.·Product code PDU·2012-03-12
K113860 — VISUAL-ICE CRYOABLATION SYSTEMGalil Medical, Inc.·Product code GEH·2012-03-12
K110761 — MICT TSHMagnabiosciences, LLC·Product code JLW·2012-03-09
K112077 — HBIDB - HUMAN BRIAN INDEX SOFTWARECorscience GmbH & Co. KG·Product code OLU·2012-03-09
K112638 — NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPSNova Biomedical Corporation·Product code NBW·2012-03-09
K112659 — SURGICAL RETRACTORSSurgical Innovations Plc·Product code GCJ·2012-03-09
K112802 — PIPELINE TOTAL HIP SYSTEMPipeline Orthopedics·Product code OQG·2012-03-09
K113260 — MODIFIED CONCENTIRC MICROCATHETERConcentric Medical, Inc.·Product code DQO·2012-03-09
K113413 — ASCEND SHOULDER SYSTEMTornier, Inc.·Product code KWS·2012-03-09
K113423 — KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVEKimberly-Clark Corp.·Product code LZA·2012-03-09

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