FDA 510(k) clearances — page 686

176,637 clearances on record, most recent first.

Clearances — page 686

68,501–68,600 of 176,637

K041792 — FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211Fresenius Medical Care North America·Product code KDJ·2004-09-24
K041837 — INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTEDInnolatex Sdn. Bhd·Product code HIS·2004-09-24
K041925 — ST360 SPINAL FIXATION SYSTEMZimmer Spine, Inc.·Product code KWP·2004-09-24
K042011 — POWER SCOOTER, MODEL TL0821Teh Lin Prosthetic & Orthopaedic, Inc.·Product code INI·2004-09-24
K042012 — TEH LIN POWER SCOOTER, MODEL TL-822Teh Lin Prosthetic & Orthopaedic, Inc.·Product code INI·2004-09-24
K042019 — HOFFMANN II MICRO EXTERNAL FIXATION SYSTEMHowmedica Osteonics Corp.·Product code KTT·2004-09-24
K042158 — KODAK MEDICAL IMAGER 300Eastman Kodak Company·Product code LMC·2004-09-24
K042159 — KODAK COLOR MEDICAL IMAGER 1000Eastman Kodak Company·Product code LMC·2004-09-24
K042198 — PS MEDICAL NEUROSURGICAL IMPLANTSMedtronic Neurosurgery·Product code JXG·2004-09-24
K042203 — LEONARDO SYNGO CARDIOLOGY WORKSTATIONSiemens Medical Solutions USA, Inc.·Product code LLZ·2004-09-24
K042312 — JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFESmith & Nephew, Inc.·Product code KTT·2004-09-24
K042317 — CERVICAL PLATEScient'X·Product code KWQ·2004-09-24
K042342 — MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COILUsa Instruments, Inc.·Product code MOS·2004-09-24
K042412 — MODIFIED SPACEMAKER SYSTEMUnited States Surgical, A Division of Tyco Healthc·Product code GCJ·2004-09-24
K042442 — QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODEOrion Diagnostica, OY·Product code DCK·2004-09-24
K041127 — MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORSSterilmed, Inc.·Product code NLF·2004-09-23
K041279 — IMPLANTEO IMPLANTOLOGY MOTORAnthogyr·Product code EKX·2004-09-23
K041591 — SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTSHowmedica Osteonics Corp.·Product code JWH·2004-09-23
K041722 — MODIFICATION TO VBR SPINAL SYSTEMDepuy Spine, Inc.·Product code MQP·2004-09-23
K041909 — VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)Vascular Solutions, Inc.·Product code DQO·2004-09-23
K042016 — DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETERDatascope Corp.·Product code MSD·2004-09-23
K042105 — CLIPPER DIAGNOSTIC ELECTRODE CATHETERBard Electrophysiology·Product code DRF·2004-09-23
K042276 — D-VAPORDraeger Medical, Inc.·Product code CAD·2004-09-23
K042374 — STOCKERT SCP RHYTHMStockert Instrumente GmbH·Product code DWA·2004-09-23
K042456 — Lysus Infusion SystemEkos Corp.·Product code QEY·2004-09-23
K032922 — CLARISSA INFANT NCPAP CANNULAAirways Ltd., Inc.·Product code CBK·2004-09-22
K040213 — MHLX7EC TRANSDUCERMicrohelix, Inc.·Product code ITX·2004-09-22
K040915 — MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150MInvivo Research, Inc.·Product code MWI·2004-09-22
K041330 — IPLAN! FLOWBrainlab AG·Product code HAW·2004-09-22
K041734 — AMBU DISPOSABLE ECG ELECTRODEAmbu, Inc.·Product code DRX·2004-09-22
K041890 — CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12Cryocor, Inc.·Product code OCL·2004-09-22
K041902 — MANTRA ELECTRODEMantra Intl. (Hk) , Ltd.·Product code GXY·2004-09-22
K042122 — SMARTINFUSER PAINPUMPPrecise Medical Products·Product code MEB·2004-09-22
K042426 — TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)Taiject Medical Device Co., Ltd.·Product code MEG·2004-09-22
K042463 — HOLTER PLUSRozinn Electronics, Inc.·Product code DQK·2004-09-22
K040070 — ARTELON SPACER CMC-1Artimplant AB·Product code KYI·2004-09-21
K041732 — CAVERMAP SURGICAL AIDBlue Torch Medical Technologies·Product code FGM·2004-09-21
K041779 — NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-LNipro Medical Corp.·Product code FMG·2004-09-21
K041805 — MICROSCOPE SYSTEMMiras Mirror Imaging Solutions, Ltd.·Product code EIA·2004-09-21
K042042 — ULTRASOUND CAPTURE SYSTEMHeartlab, Inc.·Product code LLZ·2004-09-21
K042215 — RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENTPremier Dental Products Co.·Product code EMA·2004-09-21
K042354 — MODIFICATION TO: CRESCO TI IMPLANT CONCEPTCresco TI Systems AB·Product code DZE·2004-09-21
K042462 — AMERICAN DENTAL IMPLANTAmerican Dental Implant Corporation·Product code DZE·2004-09-21
K032878 — KUNG SHIN, HMEF SK203Kung Shin Plastics Co., Ltd.·Product code CAH·2004-09-20
K040209 — IRIS MEDICAL IQ 810 PHOTOCOAGULATORIridex Corp·Product code HQF·2004-09-20
K041268 — SILVERSITE OR CALGITROLAdri·Product code MGQ·2004-09-20
K041491 — ZEWA MFM-007 BLOOD PRESSURE MONITORZewa, Inc.·Product code DXN·2004-09-20
K041524 — GE DATEX-OHMEDA HELIOX DELIVERY SYSTEMDatex-Ohmeda, Inc.·Product code CBK·2004-09-20
K041593 — FEATHERLIFT EXTENDED LENGTH APTOS THREADSurgical Specialties Corp·Product code GAW·2004-09-20
K041863 — VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FSOrtho-Clinical Diagnostics, Inc.·Product code DHR·2004-09-20
K042100 — BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTORBlackstone Medical, Inc.·Product code MNI·2004-09-20
K042142 — CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700SChad Therapeutics, Inc.·Product code NFB·2004-09-20
K042205 — BONE FUSION PLATE SYSTEMWrightmedicaltechnologyinc·Product code HRS·2004-09-20
K042261 — MACROPORE PURICEL LIPOPLASTY SYSTEMMacropore Biosurgery, Inc.·Product code QPB·2004-09-20
K042296 — BIOMARC PRELOADED TISSUE MARKER DEVICECarbon Medical Technologies, Inc.·Product code NEU·2004-09-20
K042341 — ULTRACLIP II USInrad·Product code NEU·2004-09-20
K042346 — LNCS OXIMETRY SENSORSMasimo Corporation·Product code DQA·2004-09-20
K042378 — NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVEShijiazhuang Tillotson Rubber Products Co., Ltd.·Product code LZA·2004-09-20
K033543 — NARCOTREND, MODEL COMPACT 4.0Mt Monitortechnik GmbH & Co. KG·Product code OLW·2004-09-17
K040533 — EZ HUBER SAFETY INFUSION SETPfm Medical, Inc.·Product code FPA·2004-09-17
K041074 — BD FACSCANTO WITH BD FACSANTO SOFTWAREBd Biosciences·Product code GKZ·2004-09-17
K041894 — ORTHOFIBERCp Medical·Product code GAT·2004-09-17
K042041 — XPLORER 1600Imaging Dynamics Company Limited·Product code MQB·2004-09-17
K042085 — CRONO FCane S.R.L.·Product code FRN·2004-09-17
K042145 — READY-HEAT BLANKETTechtrade, LLC·Product code KME·2004-09-17
K042146 — ROBOCOUCH PATIENT SUPPORT SYSTEMAccuray Incorporated·Product code JAI·2004-09-17
K042235 — ORION ANTERIOR CERVICAL PLATING SYSTEMMedtronic Sofamor Danek·Product code KWQ·2004-09-17
K042251 — BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLC·Product code GKZ·2004-09-17
K042335 — ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05Bio-Rad Laboratories, Inc.·Product code JJY·2004-09-17
K042428 — SCEPTREP3 PET/CTHitachi Medical Systems America, Inc.·Product code KPS·2004-09-17
K033570 — MEDCOMP T-3Medcomp·Product code NIE·2004-09-16
K033599 — ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSThe Lagado Corp.·Product code HQD·2004-09-16
K040377 — RII INFRARED EAR THERMOMETER, MODELS THXXN SERIESRadiant Innovation, Inc.·Product code FLL·2004-09-16
K040591 — DUET SYSTEMBioview , Ltd.·Product code JOY·2004-09-16
K040904 — PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068APhilips Medical Systems·Product code NSA·2004-09-16
K041021 — RF INTRODUCTION CANNULAEpimed International, Inc.·Product code GXI·2004-09-16
K041437 — MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREETerang Nusa Sdn Bhd·Product code KGO·2004-09-16
K041535 — LSC LIFESTAND COMPACTLifestand·Product code IPL·2004-09-16
K041592 — CORAL SPINAL SYSTEMTheken Surgical·Product code KWP·2004-09-16
K041663 — ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBMWrightmedicaltechnologyinc·Product code MQV·2004-09-16
K041751 — COMPRESSION ANASTOMOSIS CLIP (CAC)Niti Medical Technologies , Ltd.·Product code FZP·2004-09-16
K041822 — ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICEACON Laboratories, Inc.·Product code DKZ·2004-09-16
K041989 — SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.XSintea Biotech, Inc.·Product code KWQ·2004-09-16
K041991 — ASPIREX - BONE MARROW ASPIRATE KITIsotis Orthobiologics, Inc.·Product code FMF·2004-09-16
K042030 — HYPROCURE SUBTALAR IMPLANT SYSTEMGraham Medical Technologies, LLC·Product code HWC·2004-09-16
K042072 — CALLOS CMF BONE VOID FILLERSkeletal Kinetics, LLC·Product code GXP·2004-09-16
K042195 — SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747Beckman Coulter, Inc.·Product code LBS·2004-09-16
K042223 — XLTEK CONNEX IP HEADBOX, MODEL 1054Excel Tech. , Ltd.·Product code OMB·2004-09-16
K042237 — EBI PERIARTICULAR PLATING SYSTEMEbi, L.P.·Product code HRS·2004-09-16
K042238 — CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVESSeal Polymer Industries Bhd.·Product code LZA·2004-09-16
K042244 — BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICETriage Medical, Inc.·Product code HWC·2004-09-16
K042281 — MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAYBeckman Coulter, Inc.·Product code JLW·2004-09-16
K042295 — SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020Linvatec Biomaterials, Ltd.·Product code HWC·2004-09-16
K042310 — ORTHO-PRO CANNULATED BONE SCREWSOrtho-Pro, LLC·Product code HWC·2004-09-16
K042326 — ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNERUltrasonix Medical Corporation·Product code IYN·2004-09-16
K042338 — CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRELake Region Mfg., Inc.·Product code DQX·2004-09-16
K042429 — THE PRODIGY SYSTEM DENTAL IMPLANTSBioHorizons Implant Systems, Inc.·Product code DZE·2004-09-16
K033634 — EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODEDCenterpulse Orthopedics, Inc.·Product code KWA·2004-09-15
K040942 — VST3Biowatch Medical, Inc.·Product code DXH·2004-09-15
K041206 — EPITOME SYSTEMGebauer Medizintechnik GmbH·Product code HNO·2004-09-15

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