FDA 510(k) clearances — page 704

176,637 clearances on record, most recent first.

Clearances — page 704

70,301–70,400 of 176,637

K033933 — POWERLITE 600 EX SYSTEMPreswede AB·Product code GEX·2004-03-16
K034012 — SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAESmith & Nephew, Inc.·Product code GXI·2004-03-16
K034032 — PLV CONTINUUM VENTILATOR, MODEL P2000Respironics California, Inc.·Product code NOU·2004-03-16
K040162 — CORRESTORE PATCH SYSTEMSomanetics Corp.·Product code DXZ·2004-03-16
K040492 — VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELERBoston Scientific Corp·Product code MSD·2004-03-16
K040503 — ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOURWrp Asia Pacific Sdn. Bhd.·Product code KGO·2004-03-16
K040505 — ZILVER 635 BILIARY STENTCook, Inc.·Product code FGE·2004-03-16
K040550 — LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESISOrbus Medical Technologies·Product code FGE·2004-03-16
K021569 — RESTFUL NIGHTS, IST-APPLIANCEOttawa Dental Laboratory·Product code LRK·2004-03-15
K032743 — APEX NRGMedicnrg , Ltd.·Product code LQY·2004-03-15
K033762 — SERRALAPGSerral, S.A. DE C.V.·Product code GAM·2004-03-15
K034052 — BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVESLatexx Manufacturing Sdn.Bhd.·Product code LZA·2004-03-15
K040076 — ANSPACH ADVANCED MICRO SAW ATTACHMENTSThe Anspach Effort, Inc.·Product code HBE·2004-03-15
K040286 — ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFSEthox Corp.·Product code DXQ·2004-03-15
K040298 — ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITSAcist Medical Systems, Inc.·Product code DXT·2004-03-15
K040355 — VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATINGGish Biomedical, Inc.·Product code DTR·2004-03-15
K040472 — FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURETeleflex Medical·Product code GAT·2004-03-15
K040551 — COLTOLUX LED CURING LIGHTColtene/Whaledent, Inc.·Product code EBZ·2004-03-15
K031064 — INVACARE POLARIS EX CPAP, MODEL ISP3000Invacare Corp.·Product code BZD·2004-03-12
K031794 — ENDOFLEX TRACHEAL TUBEMerlyn Associates, Inc.·Product code BTR·2004-03-12
K032936 — DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATORStanbio Laboratory·Product code JIX·2004-03-12
K033503 — RFS VACUUM GAUGE SCAVENGING CIRCUITAccutron, Inc.·Product code CBN·2004-03-12
K033870 — IMAGE MANAGEMENT SYSTEMWelch Allyn, Inc.·Product code HEX·2004-03-12
K033893 — SPECTRUM MODULAR SYSTEMDePuy Orthopaedics, Inc.·Product code LPH·2004-03-12
K033919 — CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNSCiba Vision Corporation·Product code LPL·2004-03-12
K033944 — STELKAST 32MM MODULAR CERAMIC FEMORAL HEADStelkast Company·Product code LZO·2004-03-12
K040022 — STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEMStryker Leibinger·Product code HRS·2004-03-12
K040077 — IMMUNICON CELLTRACKS AUTOPREP SYSTEMImmunicon Corp.·Product code GKH·2004-03-12
K040112 — TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATETri-Med, Inc.·Product code HRS·2004-03-12
K040295 — APPLIED LAPAROSCOPIC MONOPOLAR SCISSORSApplied Medical Resources Corp.·Product code HET·2004-03-12
K040320 — SINON POWER WHEELCHAIR, SN-P401Sinon Corporation·Product code ITI·2004-03-12
K040346 — MODIFICATION TO ORIA TOP CLIP SYSTEMOrtho Tec, LLC·Product code MNI·2004-03-12
K040351 — RANDOX LIQUID CRP CONTROLSRandox Laboratories, Ltd.·Product code JJX·2004-03-12
K040360 — EMU128S, MODEL EX-NW-128SExcel Tech. , Ltd.·Product code GWQ·2004-03-12
K040447 — TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088Boston Scientific Corp·Product code LQC·2004-03-12
K033177 — POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXXGunter Bissinger Medizintechnik GmbH·Product code HET·2004-03-11
K033351 — GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEEGlobal Orthopaedic Technology, USA, Inc.·Product code HRY·2004-03-11
K033668 — NAVIPRO KNEE SOFTWARE MODULEKinamed, Inc.·Product code HAW·2004-03-11
K033846 — KAEN YIH UMBILICAL CORD CLAMPKaen Yih Enterprise Co., Ltd.·Product code HFW·2004-03-11
K033876 — DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422Dolphin Medical, Inc.·Product code DQA·2004-03-11
K033894 — PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032Matsushita Electric Works, Ltd.·Product code DXN·2004-03-11
K033913 — PROGREATTerumo Medical Corp.·Product code KRA·2004-03-11
K034028 — ATH FEMORAL STEMWrightmedicaltechnologyinc·Product code JDI·2004-03-11
K040009 — FREELITE HUMAN KAPPA AND LAMBDA KITSThe Binding Site, Ltd.·Product code DFH·2004-03-11
K040106 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVEBecton, Dickinson & CO·Product code LON·2004-03-11
K040280 — PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLSRoche Diagnostics Corp.·Product code JJY·2004-03-11
K040291 — EL-ANA PROFILES: ANTI-CHROMATINTheratest Laboratories, Inc.·Product code LJM·2004-03-11
K040353 — FLIGHT SOCKSsl Americas, Inc.·Product code DWL·2004-03-11
K040370 — WBR-FHR, WBR-FWBUltraspect , Ltd.·Product code KPS·2004-03-11
K040453 — AUTOPULSE RESUSCITATION SYSTEM, MODEL 100Revivant Corp.·Product code DRM·2004-03-11
K040486 — MEDIPACSNeobit Co., Ltd.·Product code LLZ·2004-03-11
K040534 — VITALAB AMYLASE REAGENTClinical Data, Inc.·Product code JFJ·2004-03-11
K030797 — S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEMResmed Corp·Product code BZD·2004-03-10
K030920 — POGS 33On Site Gas Systems, Inc.·Product code CAW·2004-03-10
K032803 — DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEMDatex-Ohmeda·Product code BSZ·2004-03-10
K032885 — VIDAPORT INTRAOSSEOUS INFUSION SYSTEMVidacare Corporation·Product code FMI·2004-03-10
K032932 — DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATORStanbio Laboratory·Product code LBS·2004-03-10
K033080 — PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETERPortex, Inc.·Product code CAZ·2004-03-10
K033518 — LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103Custom Plastic Products·Product code BZG·2004-03-10
K033549 — STARLUX PULSED LIGHT SYSTEMPalomar Medical Products, Inc.·Product code GEX·2004-03-10
K033841 — RESMED S8 PRIME CPAP SYSTEMResmed, Ltd.·Product code BZD·2004-03-10
K033880 — ELECTRO-LUBEMectra Labs, Inc.·Product code GEI·2004-03-10
K033921 — AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10Diagnostic Chemicals , Ltd.·Product code JIF·2004-03-10
K034000 — VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATORClinical Data, Inc.·Product code CDT·2004-03-10
K034046 — RNK TELEPHONIC STETHOSCOPE, MODEL TR-1Rnk Products·Product code DQD·2004-03-10
K034048 — R&D GLU-LINE HEMATOLOGY CONTROLR&D Systems, Inc.·Product code JJX·2004-03-10
K040086 — HEALTH BUDDY WITH BUDDYLINKHealth Hero Network, Inc.·Product code DXN·2004-03-10
K040277 — LIQUICHEK CARDIAC MARKER CONTROL LTBio-Rad Laboratories, Inc.·Product code JJY·2004-03-10
K040431 — ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2Roche Diagnostics Corp.·Product code DAO·2004-03-10
K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.·Product code DEW·2004-03-10
K040435 — ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.·Product code CZP·2004-03-10
K040471 — OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024Olympus America, Inc.·Product code JIT·2004-03-10
K040473 — ORAVIVE TOOTH REVITALIZING PASTENovamin Technology, Inc.·Product code LBH·2004-03-10
K032459 — PROFILE 1320 LASER SYSTEMSciton, Inc·Product code GEX·2004-03-09
K032560 — ARROWHEAD SPINAL SYSTEMMedtronic Sofamor Danek·Product code NKB·2004-03-09
K033191 — SOHNIKSSohniks Endoscopy, Inc.·Product code FAJ·2004-03-09
K033258 — BONESAVE BONE VOID FILLERHowmedica Osteonics·Product code MQV·2004-03-09
K033496 — MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USEIndustrial Clothings, Ltd.·Product code LYY·2004-03-09
K033807 — INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTERDraeger Medical Systems, Inc.·Product code DRQ·2004-03-09
K033861 — BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAYBecton, Dickinson & CO·Product code LQH·2004-03-09
K033892 — ULTRAFLEX INFUSION SETDisetronic Medical Systems AG·Product code FPA·2004-03-09
K033967 — TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND PFlir Systems·Product code LHQ·2004-03-09
K034057 — LACRYTESTAdiatec SA·Product code DGC·2004-03-09
K034059 — SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGESectra AB·Product code LLZ·2004-03-09
K040001 — STEERABLE STYLETSynovis Surgical Innovations·Product code DRB·2004-03-09
K040134 — THERILINK BONE VOID FILLERTherics, Inc.·Product code MQV·2004-03-09
K040302 — VERSAPOINT RESECTOSCOPIC SYSTEMGynecare, A Div. of Ethicon, Inc.·Product code HIH·2004-03-09
K040347 — SIREMOBIL ISO-C 3DSiemens Medical Systems, Inc.·Product code OXO·2004-03-09
K040348 — MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COILMri Devices Corp.·Product code MOS·2004-03-09
K040349 — MODIFICATION TO HRW-127 WRIST ARRAY COILMri Devices Corp.·Product code MOS·2004-03-09
K040456 — FLEBOSET MULTIPLELaboratorios Grifols, S.A.·Product code LHI·2004-03-09
K040502 — SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMSSiemens Medical Solutions USA, Inc.·Product code IYO·2004-03-09
K032091 — SMART KLAMP VARIOUS BY SIZEEmergogroup, Inc.·Product code HFX·2004-03-08
K034067 — ZTI IMPLANTS SYSTEM, DRM IMPLANTSDrm Research Laboratories, Inc.·Product code DZE·2004-03-08
K040092 — AMEDITECH IMMU TEST DRUG SCREEN PANELAmeditech, Inc.·Product code DKZ·2004-03-08
K040160 — QUANTA PLEX SLE PROFILE 8Inova Diagnostics, Inc.·Product code LLL·2004-03-08
K040325 — PANORET, MODEL PNM 60Medibell Medical Vision Technologies , Ltd.·Product code HKI·2004-03-08
K040329 — MODIFICATION TO E.P.T. PREGNANCY TESTUnipath , Ltd.·Product code LCX·2004-03-08
K040341 — CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TESTUnipath , Ltd.·Product code LCX·2004-03-08
K040467 — VITALAB URIC ACID REAGENTClinical Data, Inc.·Product code KNK·2004-03-08

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