FDA 510(k) clearances — page 1070

176,637 clearances on record, most recent first.

Clearances — page 1070

106,901–107,000 of 176,637

K944398 — SUNGLASSESSun Island Enterprise Co., Ltd.·Product code HQY·1994-12-15
K944421 — E.COLI 0157 LATEX TESTPro-Lab Diagnostics·Product code GMZ·1994-12-15
K944474 — OPTILITE V FIBEROPTIC ACCESSORIESXintec Corporation·Product code GEX·1994-12-15
K944523 — HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNERHumphrey, Inc.·Product code IYO·1994-12-15
K944575 — AQUAFRESH PLAQUE FIGHTING GUMSmithkline Beecham Consumer Healthcare Products·Product code EJR·1994-12-15
K944603 — CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENSConmedcorp·Product code GXY·1994-12-15
K944845 — ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENTWrightmedicaltechnologyinc·Product code JWH·1994-12-15
K944857 — GOGGLE SAFEGUARDSellstrom Mfg. Co.·Product code HOY·1994-12-15
K944876 — HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KITResearch Diagnostics, Inc.·Product code DAS·1994-12-15
K944880 — BODILY FLUID DISPOSAL KITClinical Resources, Inc.·Product code FXX·1994-12-15
K945173 — PULPDENT HARDSHELLPulpdent Corp.·Product code EBF·1994-12-15
K945176 — SPECTACLE FRAME OR EYEGLASS FRAMESOptipia Trading Co.·Product code HQZ·1994-12-15
K945238 — MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2F. Walter Hanel GmbH·Product code IWQ·1994-12-15
K945392 — SPECTACLE FRAMESeo Han Corp., Ltd.·Product code HQZ·1994-12-15
K945563 — CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM))Energy Life Systems Corp.·Product code GEX·1994-12-15
K945751 — KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVESKARL STORZ Endoscopy-America, Inc.·Product code GCJ·1994-12-15
K945770 — OPTICAL FRAMESRamada Optics, Inc.·Product code HQZ·1994-12-15
K945970 — INSUFFLATOR FILTER TUBING SETXylog Corp.·Product code FCX·1994-12-15
K935587 — MULTILINK SHOULDER CPM UNITToronto Medical Corp.·Product code BXB·1994-12-14
K941171 — TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)Miles, Inc.·Product code GKZ·1994-12-14
K942286 — DIARLEX ROTA-ADENOOrion Diagnostica, Inc.·Product code LIQ·1994-12-14
K942434 — BIONAIRE CLEAR AIR AIR PURIFIER & IONIZERBionaire Corp.·Product code FRF·1994-12-14
K942826 — ORTHODONITC METAL REINFORCED PLASTIC BRACKETGac Intl., Inc.·Product code DYW·1994-12-14
K942911 — GLYCAR TISSUE REPAIR PATCHGlycar, Inc.·Product code FTL·1994-12-14
K943016 — ADOBE C.I.CWidex Hearing Aid Co., Inc.·Product code ESD·1994-12-14
K943740 — ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)Premium Plastics, Inc.·Product code FMI·1994-12-14
K943794 — MX4000Bfi- Medical Waste Systems·Product code FMI·1994-12-14
K944848 — THE VIVACARE T.P.S. PROBERms Div.·Product code EIX·1994-12-14
K944973 — NRF SYSTEMPhilips Medical Systems (Cleveland), Inc.·Product code JAA·1994-12-14
K945018 — PULPDENT HARD DENTAL POSTERIOR FILLING MATERIALPulpdent Corp.·Product code EBF·1994-12-14
K945055 — HARKEN ASSURE SELF-SEAL STERILIZATION POUCHHarken Products, Inc.·Product code KCT·1994-12-14
K945056 — PULPDENT RESIN CEMENTPulpdent Corp.·Product code EBF·1994-12-14
K945057 — PULPDENT HYBRID ANTERIOR COMPOSITEPulpdent Corp.·Product code EBF·1994-12-14
K945058 — PULPDENT MICROFILLED ANTERIOR COMPOSITEPulpdent Corp.·Product code EBF·1994-12-14
K945112 — PULPDENT DUAL CURE UNFILLED BONDING RESINPulpdent Corp.·Product code KLE·1994-12-14
K945113 — PULPDENT CERVICAL RESTORATIVEPulpdent Corp.·Product code EBF·1994-12-14
K945272 — RHODIUM FILTERLorad Corp.·Product code IZH·1994-12-14
K945273 — PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2Pro-Tec Containers, Inc.·Product code FMI·1994-12-14
K945274 — PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80Pro-Tec Containers, Inc.·Product code FMI·1994-12-14
K945275 — PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1Pro-Tec Containers, Inc.·Product code FMI·1994-12-14
K945276 — PRO-TEC DISPOSABLE SHARPS CONTAINERS 5GPro-Tec Containers, Inc.·Product code FMI·1994-12-14
K945278 — PHILIPS BUCKY DIAGNOST FAMILYPhilips Medical Systems North America, Inc.·Product code KPR·1994-12-14
K945708 — SII 360 MSScott Imaging Intl., Inc.·Product code KPR·1994-12-14
K945709 — SII 525 MSScott Imaging Intl., Inc.·Product code KPR·1994-12-14
K932521 — POWDERFREE LATEX EXAMINATION GLOVESTop Glove Sdn. Bhd.·Product code LYY·1994-12-13
K933846 — ANGIOGRAPHY SYRINGE KITSAngiodynamics, Div. E-Z-Em, Inc.·Product code DXT·1994-12-13
K941902 — MODEL 3471 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.·Product code JRE·1994-12-13
K941904 — MODEL A300CL CLINICAL REFRACTOMETERVee Gee Scientific, Inc.·Product code JRE·1994-12-13
K941905 — MODEL 3461 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.·Product code JRE·1994-12-13
K941978 — HIGH PRESSURE TUBINGAbbott Laboratories·Product code DQO·1994-12-13
K942168 — WGL ENDOSCOPIC GRASPERWilson Greatbatch Technologies, Inc.·Product code GCJ·1994-12-13
K942729 — LIHTAN 4100 KRYPTONLihtan Technologies, Inc.·Product code GEX·1994-12-13
K943000 — ALBUMIN QVETPrisma Systems·Product code CIX·1994-12-13
K943045 — UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTEDReliant Technologies, Inc.·Product code GEX·1994-12-13
K944102 — AST QVETPrisma Systems·Product code CIT·1994-12-13
K944208 — IV ADMINISTRATION SET FPAMedex, Inc.·Product code FPA·1994-12-13
K944354 — CONTOUR EMBOLIInterventional Therapeutics Corp.·Product code HCG·1994-12-13
K944607 — MODEL 5135 AUTO LP/FLASHRichard Wolf Medical Instruments Corp.·Product code GCT·1994-12-13
K944637 — FAMILY FITNESS SHIATSU MASSAGERConair Corp.·Product code ISA·1994-12-13
K944762 — PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWAREPuritan Bennett Corp.·Product code BZG·1994-12-13
K944970 — SOLUTIONFreedom Designs, Inc.·Product code IOR·1994-12-13
K945263 — OPTUS THORACOSCOPESOptus, Inc.·Product code GCJ·1994-12-13
K945289 — DOA - IMMUNOASSAY CUT-OFF CALIBRATORMedi-Tech, Inc.·Product code DKB·1994-12-13
K945350 — FRAME, SPECTACLESTaiwan Eva Industrial Co., Inc.·Product code HQZ·1994-12-13
K945351 — SHIELD, EYE, OPHTHALMICTaiwan Eva Industrial Co., Inc.·Product code HOY·1994-12-13
K945805 — WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBEWells Johnson Co.·Product code GEI·1994-12-13
K945893 — DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODEBoston Surgical Products, Inc.·Product code GEI·1994-12-13
K945898 — ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIESMegadyne Medical Products, Inc.·Product code GEI·1994-12-13
K930498 — NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRANNeuromed, Inc.·Product code GZB·1994-12-12
K933467 — PRN ADAPTERBd Becton Dickinson Vacutainer Systems Preanalytic·Product code FOZ·1994-12-12
K936015 — DISPOSABLE DISC FILTERMedi-Dose, Inc.·Product code FMF·1994-12-12
K940230 — ENDOSCOPIC MORTONS NEUROMA INSTRUMENTSInstratek, Inc.·Product code HRX·1994-12-12
K941251 — FINESSE IEC/601Utah Medical Products, Inc.·Product code HGI·1994-12-12
K941450 — INVIRO SYRINGEDr. F. Ross Sharp , Ltd.·Product code MEG·1994-12-12
K941818 — PM9000 VAC TRAPPrecision Medical, Inc.·Product code KDQ·1994-12-12
K942581 — BES - BREATH EXPOSURE SYNCHRONIZERThe Henry G. Dietz Co., Inc.·Product code KPR·1994-12-12
K943297 — CIBA CORNING ACS FOLATE ASSAYCiba Corning Diagnostics Corp.·Product code CGN·1994-12-12
K943335 — RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLER&D Systems, Inc.·Product code JPK·1994-12-12
K943336 — RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLER&D Systems, Inc.·Product code JPK·1994-12-12
K943353 — PLEXUS/1000Plexus Medical·Product code FNM·1994-12-12
K943679 — UNIVEC NONRESUSABLE LOCKING SYRINGEUnivec, Inc.·Product code FMI·1994-12-12
K943733 — FLEXIFLO SIX ENTERAL NUTRITION PUMPAbbott Mfg., Inc.·Product code LZH·1994-12-12
K943900 — LATEX MEDICAL GLOVEJohnson & Johnson Medical, Inc.·Product code LYY·1994-12-12
K944347 — PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)Puritan Bennett Corp.·Product code BTM·1994-12-12
K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSBeckman-Diagnostic Systems Group·Product code DFT·1994-12-12
K931318 — 3400 INFUSION PUMPGraseby Medical , Ltd.·Product code FRN·1994-12-09
K935773 — EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENTExactech, Inc.·Product code JWH·1994-12-09
K935983 — MICROREADER 4Hyperion, Inc.·Product code JJQ·1994-12-09
K940660 — MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEMVictoreen, Inc.·Product code IYE·1994-12-09
K941224 — LENZAR REMOTE ACQUISITION SYSTEMLenzar Electrooptics, Inc.·Product code LMD·1994-12-09
K942960 — PHOSPHATE QVETPrisma Systems·Product code CEO·1994-12-09
K942961 — AMYLASE QVETPrisma Systems·Product code JFJ·1994-12-09
K943003 — CALCIUM QVETPrisma Systems·Product code CJJ·1994-12-09
K943004 — TOTAL PROTEIN QVETPrisma Systems·Product code CEK·1994-12-09
K943026 — POTASSIUM QVETPrisma Systems·Product code CEJ·1994-12-09
K943799 — VERSION 5 OPERATING SYSTEM SOFTWAREHitachi Medical Systems America, Inc.·Product code LNH·1994-12-09
K944134 — K6-1 DIAGNOSTIC SYSTEM VERSION 3.1Myo-Tronics, Inc.·Product code KZM·1994-12-09
K944182 — POWDER FREE MEDICAL GLOVEBd Becton Dickinson Vacutainer Systems Preanalytic·Product code LYZ·1994-12-09
K944184 — SYNTHETIC MEDICAL GLOVESBd Becton Dickinson Vacutainer Systems Preanalytic·Product code LYZ·1994-12-09
K944209 — APR II NON POROUS HIP STEMIntermedics Orthopedics·Product code LZO·1994-12-09

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