FDA 510(k) clearances — page 716

176,637 clearances on record, most recent first.

Clearances — page 716

71,501–71,600 of 176,637

K033071 — SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEMSynthes (Usa)·Product code JDS·2003-11-05
K033093 — ECHOCONNEX COMMUNICATORConnexmd·Product code LLZ·2003-11-05
K033102 — MEDIC COLON MODEL, RELEASE 1Medicsight·Product code JAK·2003-11-05
K033112 — WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NSHand Biomechanics Lab, Inc.·Product code KTT·2003-11-05
K033145 — HOFFMANN II PELVIC CLAMPHowmedica Osteonics Corp.·Product code LXT·2003-11-05
K033158 — SYNTHES REPROCESSED EXTERNAL FIXATION DEVICESSynthes (Usa)·Product code KTT·2003-11-05
K033224 — HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORERHologic, Inc.·Product code KGI·2003-11-05
K033233 — LACTOSORB TIBIAL L-15 SCREW AND WASHERBiomet, Inc.·Product code HWC·2003-11-05
K033247 — MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEMMedrad, Inc.·Product code DXT·2003-11-05
K033300 — VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERSOrtho-Clinical Diagnostics, Inc.·Product code DDR·2003-11-05
K033321 — SELECTIVA SB GUIDEWIRENeometrics, Inc.·Product code DQX·2003-11-05
K033361 — VIATRONIX V3D VASCULAR, REVISION 1.0Viatronix, Inc.·Product code LLZ·2003-11-05
K033367 — TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464Sonosite,Inc.·Product code IYN·2003-11-05
K033416 — SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACEMedtronic Perfusion Systems·Product code DWF·2003-11-05
K032481 — THERATEARS CONTACT LENS COMFORT DROPSAdvanced Vision Research, Inc.·Product code LPN·2003-11-04
K032597 — BISCEM GIBisco, Inc.·Product code EMA·2003-11-04
K032788 — VITEK 2 GRAM NEGATIVE GATIFLOXACINbioMerieux, Inc.·Product code LON·2003-11-04
K033274 — GIARDIA IITechlab, Inc.·Product code MHI·2003-11-04
K033277 — HYDRAGEL CSF ISOFOCUSING KITSMorax·Product code CFF·2003-11-04
K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTERMicroworld Medical Instruments, Inc.·Product code HQE·2003-11-04
K031042 — ATAC HEMOGLOBIN A1C REAGENT KITClinical Data, Inc.·Product code LCP·2003-11-03
K031708 — OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEMOsteomed LP·Product code MQN·2003-11-03
K031946 — EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGEEdwards Lifesciences, LLC·Product code DTM·2003-11-03
K032662 — GUTTAFLOWColtene/Whaledent GmbH & Co. KG·Product code KIF·2003-11-03
K032764 — BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)Lin-Zhi International, Inc.·Product code DIS·2003-11-03
K032804 — CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision Biologic·Product code GGC·2003-11-03
K033346 — SPI EASY DENTAL IMPLANT PROTECTIVE CAPThommen Medical AG·Product code NHA·2003-11-03
K013452 — DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESISDanmar Products, Inc.·Product code MVA·2003-10-31
K024013 — SUN-RAIN ULTRASONIC THERAPY, SU-100Sun-Rain System Corp.·Product code IMI·2003-10-31
K030358 — KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORKodon(Tianjin)Electronic&Electrical Apparatus Co.,·Product code DXN·2003-10-31
K030683 — NIPRO DISPOSABLE SYRINGESNipro Medical Corp.·Product code FMF·2003-10-31
K031369 — MERCATOR HEALTHCARE MALE LATEX CONDOMMercator Healthcare , Ltd.·Product code HIS·2003-10-31
K031446 — JABES ELECTRONIC STETHOSCOPEGs Technology Co., Ltd.·Product code DQD·2003-10-31
K031862 — SPINERX-LDMSpinerx Technology·Product code ITH·2003-10-31
K031963 — CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEADWrightmedicaltechnologyinc·Product code KWA·2003-10-31
K032145 — AUDICOR UPGRADE SYSTEMInovise Medical, Inc.·Product code DPS·2003-10-31
K032363 — ZOLL M SERIES NIBP OPTIONZoll Medical Corp·Product code DXN·2003-10-31
K032388 — BONE CEMENT RADIO-OPACIFIERCardinalhealth·Product code MYU·2003-10-31
K032398 — PLUS PIVOT LINK UNIVERSAL SYSTEMSpine Vision, Inc.·Product code MNI·2003-10-31
K032426 — GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SETCook, Inc.·Product code DTK·2003-10-31
K032527 — HEDROCEL VERTEBRAL BODY REPLACEMENTImplex Corp.·Product code MQP·2003-10-31
K032564 — DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111Dade Behring, Inc.·Product code LAN·2003-10-31
K032573 — DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110Dade Behring, Inc.·Product code LAR·2003-10-31
K032711 — VITEK GRAM NEGATIVE GATIFLOXACINbioMerieux, Inc.·Product code LON·2003-10-31
K032738 — VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTINbioMerieux, Inc.·Product code LON·2003-10-31
K032766 — VITEK 2 GRAM POSITIVE LINEZOLIDbioMerieux, Inc.·Product code LON·2003-10-31
K032993 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLSOrtho-Clinical Diagnostics, Inc.·Product code JJX·2003-10-31
K033037 — MODIFICATION TO GLOBALCARDIOCardiocomm Solutions, Inc.·Product code DSH·2003-10-31
K033068 — IONOFIL COLOR ACVoco GmbH·Product code EMA·2003-10-31
K033127 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLSOrtho-Clinical Diagnostics·Product code JJX·2003-10-31
K033130 — PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOROsypka Medical, Inc.·Product code DTE·2003-10-31
K033209 — FUKUDA DENSHI MODEL FF SONIC UF-750XTFukuda Denshi USA, Inc.·Product code IYN·2003-10-31
K033217 — PHERON PTA CATHETERBiotronik, Inc.·Product code DQY·2003-10-31
K033263 — K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PTTrack Corporation·Product code ITI·2003-10-31
K033264 — MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIESMedtronic Perfusion Systems·Product code DWF·2003-10-31
K033305 — INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEMDraeger Medical Systems, Inc.·Product code DSI·2003-10-31
K023509 — DBB-05 HEMODIALYSIS DELIVERY SYSTEMDavita Clinical Research (Trri)·Product code KDI·2003-10-30
K030082 — POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851Richard Wolf Medical Instruments Corp.·Product code HRX·2003-10-30
K031473 — RATIONAL IMAGING PACSIntuitive Imaging Informatics, LLC·Product code LLZ·2003-10-30
K031681 — STERISIL ANTIMICROBIAL TUBING AND BOTTLESterisil·Product code EIA·2003-10-30
K031684 — TOPKIN WOUND DRESSINGBiomet Merck GmbH·Product code QSZ·2003-10-30
K031819 — DIO-DENT 10 DENTAL DIODE LASERMsq (M2) , Ltd.·Product code GEX·2003-10-30
K031838 — PROFUSION BONE VOID FILLER KITBiogeneration·Product code MQV·2003-10-30
K032002 — FERTELL FEMALE FERTILITY TESTGenosis, Inc.·Product code NGA·2003-10-30
K032105 — ENDOHELIX ENDARTERECTOMY DEVICEEndarx, Inc.·Product code DWX·2003-10-30
K032366 — BONESOURCE HAC FAST SETTING CEMENTStryker Instruments·Product code GXP·2003-10-30
K032385 — GLOBAL PRESS-FIT STEMGlobal Medical Co.·Product code LPH·2003-10-30
K032499 — A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORSA&D Engineering, Inc.·Product code DXN·2003-10-30
K032513 — T-WAVE ALTERNANS (TWA) ALGORITHM OPTIONGe Medical Systems Information Technologies·Product code DQK·2003-10-30
K032656 — GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-XGe Med. Systems Ultrasound & Prim. Care Diag.,Llc·Product code IYN·2003-10-30
K032676 — ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAREthicon Endo-Surgery, Inc.·Product code GCJ·2003-10-30
K032731 — MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRSTurbo Wheelchair Co., Inc.·Product code IOR·2003-10-30
K032791 — GLYCOHEMOSURE HBA1C CONTROLQuantimetrix Corp.·Product code GGM·2003-10-30
K032798 — DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48ADade Behring, Inc.·Product code JHM·2003-10-30
K032915 — ADVANTAGE 4D OPTIONGe Medical Systems, LLC·Product code JAK·2003-10-30
K033016 — PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892Medtronic Neurological·Product code GZB·2003-10-30
K033125 — HANDIVIPPHandinor USA, Inc.·Product code IOR·2003-10-30
K033131 — NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068The First Years, Inc.·Product code HGX·2003-10-30
K033141 — MECHANICAL WHEEHCHAIRPacific Medical Suppliers, Inc.·Product code IOR·2003-10-30
K033172 — CANDELA GENTLEYAG FAMILY OF LASER SYSTEMSCandela Corp.·Product code GEX·2003-10-30
K033194 — INION CPS BABY 1.5 BIOABSORBABLE SYSTEMInion , Ltd.·Product code JEY·2003-10-30
K033211 — ENSITE SYSTEMEndocardial Solutions, Inc.·Product code DQK·2003-10-30
K033212 — LIFESTENT SDS BILIARY ENDOPROSTHESISOrbus Medical Technologies·Product code FGE·2003-10-30
K033257 — ARTHROCARE ENT PLASMA WANDSArthrocare Corp.·Product code GEI·2003-10-30
K023000 — HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIESHome Care Technology Co., Ltd.·Product code IPF·2003-10-29
K030120 — AMSURE FOLEY CATHETERAmsino International, Inc.·Product code EZL·2003-10-29
K031341 — STICK FLOWStick Tech , Ltd.·Product code EBF·2003-10-29
K032024 — POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)Shen Wei (Usa), Inc.·Product code LZA·2003-10-29
K032084 — POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLORShen Wei (Usa), Inc.·Product code LYZ·2003-10-29
K032119 — PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUSParagon Medical, Inc.·Product code KCT·2003-10-29
K032387 — TRIVEX SYSTEMSmith & Nephew, Inc.·Product code DWQ·2003-10-29
K032405 — GIVEN DIAGNOSTIC SYSTEMGiven Imaging , Ltd.·Product code NEZ·2003-10-29
K032442 — KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM IIKLS-Martin L.P.·Product code MQN·2003-10-29
K032599 — MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEMMedical Laser Technologies, LLC·Product code GEX·2003-10-29
K032660 — XTRAK SUPPORT CATHETERXtrak Medical, Inc.·Product code DQY·2003-10-29
K032748 — VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWAREVital Images, Inc.·Product code LLZ·2003-10-29
K032962 — AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACEArrow Intl., Inc.·Product code FOZ·2003-10-29
K033065 — SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATESSynthes (Usa)·Product code MQN·2003-10-29
K033078 — DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWAREDatex-Ohmeda·Product code MSX·2003-10-29
K033088 — SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1Sectra AB·Product code LLZ·2003-10-29

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