FDA 510(k) clearances — page 678

176,637 clearances on record, most recent first.

Clearances — page 678

67,701–67,800 of 176,637

K042846 — SYSTEMP.LINKIvoclar Vivadent, Inc.·Product code EMA·2004-12-20
K043085 — MODIFICATION TO: PNEUTON VENTILATORAiron Corporation·Product code CBK·2004-12-20
K043159 — POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGEShijaizhuang Brilliant Ocean Plastic Co., Ltd.·Product code LYZ·2004-12-20
K043221 — WILLI GELLER CREATION CP PORCELAINJensen Industries, Inc.·Product code EIH·2004-12-20
K043244 — FRESENIUS OPTIFLUX F20NR, FF18NR, F16NRFresenius Medical Care North America·Product code KDI·2004-12-20
K043412 — MODIFICATION TO: VIEWSTATIONImpac Medical Systems, Inc.·Product code LLZ·2004-12-20
K040047 — POLYGRAFT BGS; BONE GRAFT SUBSTITUTEOsteobiologics, Inc.·Product code MQV·2004-12-17
K040049 — THE RELIANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation·Product code NZA·2004-12-17
K040426 — TRANS1 AXIAL FIXATION SYSTEMTrans1, Inc.·Product code KWQ·2004-12-17
K040592 — CORDIS STEER-IT DEFLECTING TIP GUIDEWIRECordis Corp.·Product code DQX·2004-12-17
K041619 — BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116Biocheck, Inc.·Product code MMI·2004-12-17
K041987 — CORTRAKViasys Medsystems·Product code KNT·2004-12-17
K042057 — INFINITY ELECTROTHERAPY SYSTEMEmpi·Product code LIH·2004-12-17
K042248 — KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KITKronus Market Development Associates, Inc.·Product code NST·2004-12-17
K042370 — TORAYGUIDE GUIDEWIREToray Industries (America), Inc.·Product code DQX·2004-12-17
K042385 — DOC BAND-POSTOPCranial Technologies, Inc.·Product code MVA·2004-12-17
K042399 — MODIFICATION TO SHORT INTRODUCER SHEATHRex Medical, L.P.·Product code DYB·2004-12-17
K042530 — CONSERVE PLUS HA ACETABULAR SHELLSWrightmedicaltechnologyinc·Product code KWA·2004-12-17
K042638 — RADIANCE PORCELAINAurident, Inc.·Product code EIH·2004-12-17
K042654 — PROTECTION PLUS EARLOOP PROCEDURE MASKSafety-Med Products, Inc.·Product code FXX·2004-12-17
K042676 — NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYNichols Institute Diagnostics·Product code DHA·2004-12-17
K042734 — SJM RIGID SADDLE RING MODEL RSAR-(SIZE)St. Jude Medical, Inc.·Product code KRH·2004-12-17
K042783 — ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEMThe Anspach Effort, Inc.·Product code HBE·2004-12-17
K042787 — IS 40 MICROMOTORSatelec·Product code EFB·2004-12-17
K042847 — SYSTEMP.CEMIvoclar Vivadent, Inc.·Product code EMA·2004-12-17
K042878 — FLEXITIME XTREMEHeraeus Kulzer, Inc.·Product code ELW·2004-12-17
K042923 — MD-6W WIRELESS CRITICAL DATA VIEWERThe Microoptical Corporation·Product code GCJ·2004-12-17
K042943 — NOUVAG AG - VACUSON 40 AND VACUSON 60NOUVAG AG·Product code BTA·2004-12-17
K043077 — MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEMTornier·Product code KWS·2004-12-17
K043119 — AMELOGEN PLUSUltradent Products, Inc.·Product code EBF·2004-12-17
K043177 — CLEAFIL DC CORE AUTOMIXKuraray Medical, Inc.·Product code EBF·2004-12-17
K043181 — MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEMVertebron, Inc.·Product code KWQ·2004-12-17
K043293 — MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301UAcrorad Co., Ltd.·Product code KPS·2004-12-17
K043307 — CRANEX DSoredex Palodex Group OY·Product code EHD·2004-12-17
K043319 — CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIESNovalis Medical, LLC·Product code GEX·2004-12-17
K043320 — MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK IIRoche Diagnostics Corp.·Product code JJX·2004-12-17
K043355 — SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.XSintea Biotech, Inc.·Product code KWP·2004-12-17
K043366 — PERMACOL SURGICAL IMPLANTTissue Science Laboratories, Plc·Product code FTL·2004-12-17
K033266 — VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLSMedical Imaging Applications, LLC·Product code DQK·2004-12-16
K040270 — OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUMLumenis, Ltd.·Product code GEX·2004-12-16
K041679 — COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHTOnyx Medical, Inc.·Product code ILY·2004-12-16
K042239 — FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILEPt. Mandiri Inti Buana·Product code LZA·2004-12-16
K042349 — EMG MODEL SUA01 SUCTION UNITEmg Technology Co., Ltd.·Product code JCX·2004-12-16
K042805 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILEPerusahaan Getah Asas Sdn. Bhd.·Product code LZC·2004-12-16
K043258 — MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02Teleflex Medical·Product code KNT·2004-12-16
K031425 — GENTLEWAVES LED PHOTOMODULATION DEVICELight Bioscience, LLC·Product code GEX·2004-12-15
K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250Newport Medical Instruments·Product code BTI·2004-12-15
K042379 — ANEMIAPRO SELF-SCREENERBiosafe Laboratories, Inc.·Product code KHG·2004-12-15
K042386 — DIRECT DIGITIZER, REGIUS MODEL 190Konica Minolta Medical & Graphic, Inc.·Product code MQB·2004-12-15
K042863 — SCENIUMSiemens Molecular Imaging, Ltd.·Product code KPS·2004-12-15
K043087 — SOMATOM CARE CONTRAST CTSiemens Medical Solutions USA, Inc.·Product code JAK·2004-12-15
K043098 — GERBER DOUBLE ELECTRIC BREAST PUMPGerber Products Co.·Product code HGX·2004-12-15
K043131 — TORPICALGINZhermack S.P.A.·Product code ELW·2004-12-15
K043153 — INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000Intuitive Surgical, Inc.·Product code NAY·2004-12-15
K043333 — VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEMVital Images, Inc.·Product code LLZ·2004-12-15
K043350 — MISTAR, MODEL V3.2Apollo Medical Imaging Technology Pty. , Ltd.·Product code LLZ·2004-12-15
K032830 — PLLA CANNULATED INTERFERENCE SCREWAdvanced Biomaterials·Product code HWC·2004-12-14
K040671 — EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGESAnthogyr·Product code EJI·2004-12-14
K041011 — ULTRALIGHT II ND:YAG LASER SYSTEMSandstone Medical Technologies, LLC·Product code GEX·2004-12-14
K042481 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400Sophysa SA·Product code JXG·2004-12-14
K042552 — BIO-CORE INTERFERENCE SCREWBiomet, Inc.·Product code HWC·2004-12-14
K042584 — OPUS MINIMAGNUM ANCHOR WITH INSERTEROpus Medical, Inc.·Product code HWC·2004-12-14
K042592 — INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304American Medical Systems, Inc.·Product code OTN·2004-12-14
K042636 — BIOPLUSBerkeley Advanced Biomaterials, Inc.·Product code MQV·2004-12-14
K042785 — MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300Nidek, Inc.·Product code GEX·2004-12-14
K042820 — SYSTEMP.C&B PLUSIvoclar Vivadent, Inc.·Product code EBG·2004-12-14
K042962 — MODIFICATION TO CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek·Product code NKB·2004-12-14
K043190 — SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEMInnova Life Sciences Corp.·Product code NHA·2004-12-14
K043337 — ARTHREX BIO-CORKSCREW FT SUTURE ANCHORArthrex, Inc.·Product code HWC·2004-12-14
DEN040010 — VYSIS AUTOVYSION SYSTEMVysis·Product code NTH·2004-12-13
K033973 — OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSORNellcor Puritan Bennett, Inc.·Product code NLF·2004-12-13
K041238 — HELICOBACTER PYLORI IGG ELISABiohit Plc·Product code LYR·2004-12-13
K041364 — ML830 LASER SYSTEMMicrolight Corporation of America·Product code ILY·2004-12-13
K041623 — REUSABLE STERILCONTAINER FILTER MODEL #JK090Aesculap, Inc.·Product code FRG·2004-12-13
K042392 — DAPTOMYCINAb Biodisk·Product code JWY·2004-12-13
K042489 — 6F Z4 GUIDE CATHETERMedtronic Vascular·Product code DQY·2004-12-13
K042532 — BIOCARE SYSTEMS PREMIR 818Biocare Systems, Inc.·Product code ILY·2004-12-13
K042772 — EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICEEbi, L.P.·Product code NKB·2004-12-13
K042963 — VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEMbioMerieux, Inc.·Product code LON·2004-12-13
K043062 — MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEMSource-Ray, Inc.·Product code IZL·2004-12-13
K043092 — PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015Progeny, Inc.·Product code EHD·2004-12-13
K043134 — METRX WORKSTATIONMedical Metrx Solutions, Inc.·Product code LLZ·2004-12-13
K043148 — ALL FLOW PULMONARY FUNCTION FILTERAlliance Tech Medical, Inc.·Product code CAH·2004-12-13
K043278 — TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBESTeratech Corp.·Product code ITX·2004-12-13
K043332 — WHEELCHAIR, MODEL 8500-IICycling and Health Tech. Industry R&D Center·Product code IOR·2004-12-13
K032825 — VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITORMars Medical Products Co., Ltd.·Product code DXN·2004-12-10
K041553 — ARTHREX SUTURE GRAFTING KITArthrex, Inc.·Product code GAT·2004-12-10
K041833 — CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZERConsolidated Machine Corp.·Product code FLE·2004-12-10
K042099 — TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)Retinapharma Technologies, Inc.·Product code HKX·2004-12-10
K042111 — PROMEDICAL SURGICAL GOWNSPromedical Products Co., Ltd.·Product code FYA·2004-12-10
K042131 — PROMEDICAL SURGICAL DRAPESPromedical Products Co., Ltd.·Product code KKX·2004-12-10
K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093CKamiya Biomedical Co.·Product code DGC·2004-12-10
K042285 — UNICRYL MUnited Medical Industries Co. , Ltd.·Product code NEW·2004-12-10
K042461 — KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304Kendall·Product code LJS·2004-12-10
K042679 — IR VIEWERInfrared Imaging Systems, Inc.·Product code KZA·2004-12-10
K042687 — ENZYGNOST F+2 (MONOCLONAL) TEST KITDade Behring, Inc.·Product code MIF·2004-12-10
K042784 — MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEMMedrad, Inc.·Product code DXT·2004-12-10
K042873 — ANIMAS MODEL IR1250 INSULIN INFUSION PUMPAnimas Corp.·Product code LZG·2004-12-10
K043114 — KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBEKimberly-Clark Corp.·Product code KNT·2004-12-10
K043164 — PANALIGHT-BLU, MODEL 4175Dusa Pharmaceuticals, Inc.·Product code GEX·2004-12-10

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