FDA 510(k) clearances — page 967

176,637 clearances on record, most recent first.

Clearances — page 967

96,601–96,700 of 176,637

K963535 — SIGMA DIAGNOSTICS GLUCOSE REAGENTSigma Diagnostics, Inc.·Product code CGA·1997-01-17
K963695 — IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZDiagnostic Products Corp.·Product code JZO·1997-01-17
K963872 — FEMRX MORCELLATOR SYSTEMGynecare Innovation Center·Product code HET·1997-01-17
K964304 — OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLYOsteonics Corp.·Product code MNH·1997-01-17
K964306 — MAGNETIC RESONANCE DIAGNOSTIC ACCESSORYGeneral Electric Co.·Product code LNH·1997-01-17
K964327 — IPU RX-2Medirex, Inc.·Product code LLZ·1997-01-17
K964330 — BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)BioHorizons Implant Systems, Inc.·Product code DZE·1997-01-17
K964430 — PULPDENT SNOOPPulpdent Corp.·Product code LFC·1997-01-17
K964548 — APEX UNIVERSAL DRIVE SYSTEMLinvatec Corp.·Product code ERL·1997-01-17
K964583 — XRT-7.0Elscint, Inc.·Product code JAK·1997-01-17
K964586 — PRESCOTT'S LIGHT SOURCE MODEL NO. II-150Iba/Griffith·Product code FCW·1997-01-17
K964772 — AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)Ivoclar North America, Inc.·Product code EJT·1997-01-17
K964816 — AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EARAudina Hearing Instrument·Product code ESD·1997-01-17
K964856 — CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATIONCaltag Laboratories, Inc.·Product code GKZ·1997-01-17
K965013 — DIGISCOPE RX-2 (9 OPTION)Medirex, Inc.·Product code OXO·1997-01-17
K965126 — AST/SGOTDerma Media Lab., Inc.·Product code CIT·1997-01-17
K965157 — CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1Boehringer Mannheim Corp.·Product code DIF·1997-01-17
K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEMBuckman Co., Inc.·Product code MNH·1997-01-16
K960508 — PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25The Prometheus Group·Product code HIR·1997-01-16
K962632 — OMNIPULSE/OMNIPULSE-MAXTrimedyne, Inc.·Product code GEX·1997-01-16
K963930 — CTS MIDCAB/SVH BIPOLAR SCISSORSCardiothoracic Systems, Inc.·Product code GEI·1997-01-16
K964258 — INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP, MODEL 8781Richard Wolf Medical Instruments Corp.·Product code GCJ·1997-01-16
K964350 — MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMAIntermedics Orthopedics·Product code JDI·1997-01-16
K964362 — KINAMED PROFIX SYSTEMKinamed, Inc.·Product code HRS·1997-01-16
K964581 — SOFSILKUnited States Surgical, A Division of Tyco Healthc·Product code GAP·1997-01-16
K964601 — CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORYValleylab, Inc.·Product code LFL·1997-01-16
K964848 — WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CMMarlow Surgical Technologies, Inc.·Product code MFD·1997-01-16
K964527 — N RHEUMATOLOGY STANDARD SLBehring Diagnostics, Inc.·Product code JIX·1997-01-15
K964560 — BHI W/VANCOMYCIN AGARHardy Diagnostics·Product code JSO·1997-01-15
K964991 — 700-FR SERIES RADIOLUCENT STIMULATION ELECTRODESCardiotronics Systems, Inc.·Product code MKJ·1997-01-15
K943230 — MAYO HIP PROSTHESISMayo Clinic·Product code LPH·1997-01-14
K962144 — PHOENIX ETE TISSUE EXTENSION SYSTEMPhoenix Biomedical Corp.·Product code MKY·1997-01-14
K962220 — HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIERMarquest Medical Products, Inc.·Product code BZE·1997-01-14
K962223 — WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIERMarquest Medical Products, Inc.·Product code BTT·1997-01-14
K963424 — OLYMPUS LIPASE REAGENTOlympus America, Inc.·Product code CDT·1997-01-14
K964154 — SEGUE INFUSION CATHETERInterventional Innovations Corp.·Product code KRA·1997-01-14
K964227 — METAL ACETABULAR COMPONENTEncore Orthopedics, Inc.·Product code LPH·1997-01-14
K964249 — BRIDGE LONG STEM FEMORAL COMPONENTWrightmedicaltechnologyinc·Product code LZO·1997-01-14
K964275 — ALPHA POSTERIOR SPINAL SYSTEMSofamor Danek USA,Inc.·Product code KWP·1997-01-14
K960511 — GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKETGibeck, Inc.·Product code DWJ·1997-01-13
K961883 — VERSA-CATH ARTERIAL CATHETERIdeas For Medicine, Inc.·Product code DXE·1997-01-13
K962179 — STAT IM 5000 CASSETTE AUTOCLAVEScican·Product code FLE·1997-01-13
K962438 — MISTY OX TURBOHEATERVital Signs, Inc.·Product code CAF·1997-01-13
K962455 — FOUR-CHANNEL PREAMPLIFIERCadwell Laboratories, Inc.·Product code GWF·1997-01-13
K962457 — TWO-CHANNEL PREAMPLIFIERCadwell Laboratories, Inc.·Product code GWF·1997-01-13
K962458 — CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIERCadwell Laboratories, Inc.·Product code GWF·1997-01-13
K962873 — CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBEVysis·Product code OVQ·1997-01-13
K962914 — REP 3 QUTO-FLUR CHOLESTEROL-30Helena Laboratories·Product code JHO·1997-01-13
K963092 — MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETERAdam Spencer Corp.·Product code DQO·1997-01-13
K963663 — 11F GUIDING CATHETERBoston Scientific /International Technologies·Product code DQY·1997-01-13
K964331 — ASC HIGH PRESSURE BRAIDED TUBESAdam Spencer Corp.·Product code DQO·1997-01-13
K964348 — AIA-PACK B12 ASSAYTosoh Medics, Inc.·Product code CDD·1997-01-13
K964403 — SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)The First Years, Inc.·Product code HGX·1997-01-13
K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.·Product code JQB·1997-01-13
K964587 — VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEMBayer Corp.·Product code LEH·1997-01-13
K964682 — SKYWAYKid'S Wheel-Chairs·Product code IOR·1997-01-13
K964940 — TAOS 28Gateway Alloys, Inc.·Product code EJT·1997-01-13
K964941 — EL DORADO 40Gateway Alloys, Inc.·Product code EJT·1997-01-13
K964948 — AURORA 52 (PM-01)Gateway Alloys, Inc.·Product code EJT·1997-01-13
K964949 — AURORA 53Gateway Alloys, Inc.·Product code EJT·1997-01-13
K964950 — LA PLATA 28 (PM-28)Gateway Alloys, Inc.·Product code EJT·1997-01-13
K965171 — LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)Bio-Rad·Product code JJY·1997-01-13
K955384 — DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTIONAlthin Medical AB an Affiliate of Baxter Intl·Product code KDI·1997-01-10
K960966 — HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588Sunbeam-Oster Household Products·Product code FRF·1997-01-10
K962001 — MANAN PEDIATRIC BONE MARROW ACCESS NEEDLEManan Medical Products, Inc.·Product code FMI·1997-01-10
K962100 — VOLMETRIC COINCIDENCE DETECTION SYSTEMElscint, Inc.·Product code KPS·1997-01-10
K962239 — SMART ADJUSTER (SA201)Sigma·Product code LXM·1997-01-10
K962249 — PIXELL MRI SYSTEMGeneral Medical Equipment Corp.·Product code LNH·1997-01-10
K962320 — S3 CARDIOPLEGIA CONTROLStoeckert Instrumente·Product code DTR·1997-01-10
K962683 — SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATORDeknatel, Inc.·Product code HIF·1997-01-10
K962902 — FOTONA SKINLIGHT LASER SYSTEMMedical Laser Solutions·Product code GEX·1997-01-10
K962983 — STERILE SOFT-TEMPAdroit Medical Systems, Inc.·Product code ILO·1997-01-10
K962995 — ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PCOtodynamics, Ltd.·Product code EWO·1997-01-10
K963221 — OPTICAL DIGITIZER OPTION FOR VIEW POINTPhilips Medical Systems (Cleveland), Inc.·Product code HAW·1997-01-10
K963674 — LUMEX AIRLumex, Inc.·Product code FNM·1997-01-10
K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICEBioderm, Inc.·Product code EXI·1997-01-10
K964078 — 3050 SPORT-NEBMedical Industries America, Inc.·Product code CAF·1997-01-10
K964130 — AEROGEAR ASTHMA ACTION KITMonaghan Medical Corp.·Product code BZH·1997-01-10
K964136 — HYSTERO CO2-PNEU 2221Richard Wolf Medical Instruments Corp.·Product code HIG·1997-01-10
K964138 — VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWAREVarian Medical Systems, Inc.·Product code KPQ·1997-01-10
K964274 — WRITESTAR, AND VIEWSTARComview Corp.·Product code LMB·1997-01-10
K964318 — PHILIPS TOMOSCAN AV EXPANDER UPGRADEPhilips Medical Systems North America, Inc.·Product code JAK·1997-01-10
K964324 — MULTITAK SS SUTURE SYSTEMBonutti Research·Product code MBI·1997-01-10
K964340 — PORTAREM-3000, PFS-6000Starkey Laboratories, Inc.·Product code EWO·1997-01-10
K964370 — MAGNETIC RESONANCE DIAGNOSTIC SYSTEMGE Medical Systems·Product code LNH·1997-01-10
K964450 — SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORTPilling Weck Group·Product code HET·1997-01-10
K964505 — GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSESI C Optics, Ltd.·Product code HQY·1997-01-10
K964576 — PROFILE MAMMOGRAPHY SYSTEM (M-PRO)Bennett X-Ray Corp.·Product code IZH·1997-01-10
K964580 — CAP-AID (IMPROVED)Nebel, Inc.·Product code FHA·1997-01-10
K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASEDerma Media Lab., Inc.·Product code JQB·1997-01-10
K965080 — ANSPACH MICROMAX SYSTEMThe Anspach Effort, Inc.·Product code ERL·1997-01-10
K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)Pall Biomedical Products Co.·Product code FPB·1997-01-09
K955393 — NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPESurgical Innovations Plc·Product code HIF·1997-01-09
K960121 — AUTOLINK BODY PLETHYSMOGRAPHP.K. Morgan , Ltd.·Product code BZC·1997-01-09
K962965 — LIGHTSTIC MODEL 360Rare Earth Medical, Inc.·Product code GEX·1997-01-09
K962989 — AMOILS EPITHELIAL SCRUBBERS. Percy Amoils·Product code HOG·1997-01-09
K963091 — VOLLMAN PRONE POSITIONERHill-Rom, Inc.·Product code IPT·1997-01-09
K963109 — HERITAGE HIP SYSTEMZimmer, Inc.·Product code JDI·1997-01-09
K963357 — MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STESynthes (Usa)·Product code MNH·1997-01-09
K963506 — TENET RADIOLUCENT HAND TABLETenet Medical Engineering·Product code FQO·1997-01-09

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