FDA 510(k) clearances — page 853

176,637 clearances on record, most recent first.

Clearances — page 853

85,201–85,300 of 176,637

K993381 — TONGUE STABILIZER DEVICEUniversity of Otago·Product code LRK·1999-12-21
K993590 — FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SETPointe Scientific, Inc.,·Product code LCP·1999-12-21
K993612 — BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIAThe Binding Site, Ltd.·Product code MVM·1999-12-21
K993645 — CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEMGe Medical Systems, Inc.·Product code JAK·1999-12-21
K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUSXomed, Inc.·Product code GEI·1999-12-21
K993673 — SNN FLUORO NAVIGATION SYSTEMI.S.G. Technologies, Inc.·Product code HAW·1999-12-21
K993681 — DIGITEC TWO STAGE COMPRESSION KITDigitec Medical Service Corp.·Product code IZH·1999-12-21
K993687 — UROVIEW 2800Ge Dec Medical Systems·Product code OWB·1999-12-21
K993710 — MODIFICATION OF PARAPOST CEMENTColtene/Whaledent, Inc.·Product code EMA·1999-12-21
K993716 — PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUEHarry J. Bosworth Co.·Product code EBF·1999-12-21
K993727 — BINDAZYME ANTI-DSDNA EIA KITThe Binding Site, Ltd.·Product code LRM·1999-12-21
K993755 — EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5Syva Co.·Product code DKB·1999-12-21
K993796 — RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINEAmerican Bio Medica Corp.·Product code LDJ·1999-12-21
K993812 — CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 KHardy Diagnostics·Product code JSM·1999-12-21
K993868 — THE SOUNDVASER DISSECTION SYSTEMSound Surgical Technologies, LLC·Product code LFL·1999-12-21
K993883 — M-PACT CORNEAL LIGHT SHIELDM-Pact Corp.·Product code HOZ·1999-12-21
K993935 — DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPIWesley Jessen Corp.·Product code LPL·1999-12-21
K993947 — KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILYSiemens Corp.·Product code IZI·1999-12-21
K993962 — PENSIL TRAUMA, MODEL WWS6100Wuestec Medical, Inc.·Product code KPR·1999-12-21
K993994 — HARDYDISK AZITHROMYCIN 15MCGHardy Diagnostics·Product code JTN·1999-12-21
K994009 — CG-2100 ECG TRANSMITTERCard Guard Scientific Survival , Ltd.·Product code DXH·1999-12-21
K994045 — PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2Primus Corp.·Product code LCP·1999-12-21
K994101 — E. HISTOLYTICA IITechlab, Inc.·Product code KHW·1999-12-21
K994110 — LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SETDiasorin/American Standard Companies·Product code DFC·1999-12-21
K994175 — MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USESodemsystems·Product code HBB·1999-12-21
K994187 — SYNTHES CERVIFIX SYSTEMSynthes (Usa)·Product code KWP·1999-12-21
K981783 — C3 MININEPH ANTISERUMThe Binding Site, Ltd.·Product code CZW·1999-12-20
K981785 — C4 MININEPH ANTISERUMThe Binding Site, Ltd.·Product code DBI·1999-12-20
K981915 — TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATIONThe Binding Site, Ltd.·Product code JJY·1999-12-20
K982100 — IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITSThe Binding Site, Ltd.·Product code CFN·1999-12-20
K990849 — DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)Howmedica Osteonics Corp.·Product code LPH·1999-12-20
K991439 — POLLER CALIBRANTSEuropean Concerted Action on Anticoagulation·Product code GGN·1999-12-20
K991835 — HANG UPS POWER IIStl Intl., Inc.·Product code ITH·1999-12-20
K991964 — EIS THREADED SCREW FRACTURE FIXATIONGroupe Lepine·Product code HWC·1999-12-20
K992121 — EMBOLIZATION COIL SYSTEMCook, Inc.·Product code KRD·1999-12-20
K992355 — LACTOSORB TRAUMA PLATING SYSTEMBiomet, Inc.·Product code HRS·1999-12-20
K992531 — ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEMAccumetrics, Inc.·Product code JOZ·1999-12-20
K992635 — INTERFACE MODULE IDDDStoeckert Instrumente·Product code KRI·1999-12-20
K993048 — ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TESTRoche Diagnostics Corp.·Product code PSZ·1999-12-20
K993096 — PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITORLifestream Technologies, Inc.·Product code CHH·1999-12-20
K993169 — MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810AHewlett-Packard Co.·Product code DRG·1999-12-20
K993289 — SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEMSmith & Nephew, Inc.·Product code KTT·1999-12-20
K993371 — SADDLE SHAPED PATELLAWrightmedicaltechnologyinc·Product code JWH·1999-12-20
K993375 — CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMERClinical Diagnostic Solutions, Inc.·Product code KRX·1999-12-20
K993386 — LATEX EXAMINATION POWDERED GLOVESGreat Glove Sdn Bhd·Product code LYY·1999-12-20
K993402 — OPUS SPINAL SYSTEMHowmedica Osteonics Corp.·Product code MNI·1999-12-20
K993432 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46Rossmax International , Ltd.·Product code DXN·1999-12-20
K993449 — BIRD V.I.P. GOLD/STERLINGBird Products Corp.·Product code CBK·1999-12-20
K993452 — GREEN POWDERED LATEX EXAMINATION GLOVESTop Glove Sdn. Bhd.·Product code LYY·1999-12-20
K993605 — PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVESTop Glove Sdn. Bhd.·Product code LYY·1999-12-20
K993668 — LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20Laerdal Medical A/S·Product code BTA·1999-12-20
K993887 — ALATECH LATEX CONDOMAlatech Healthcare, LLC·Product code HIS·1999-12-20
K993888 — A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORSA&D Engineering, Inc.·Product code DXN·1999-12-20
K993956 — TITANIUM PEDIATRIC FEMORAL NAILBiomet, Inc.·Product code HSB·1999-12-20
K993975 — ABSOLUTE ABSORBABLE INTERFERENCE SCREWInnovasive Devices, Inc.·Product code HWC·1999-12-20
K994036 — PRE-POWDERED VINYL EXAM GLOVE, NON STERILEShanghai Champion Plastic Products Co., Ltd.·Product code LYZ·1999-12-20
K994053 — STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULEStryker Instruments·Product code FYA·1999-12-20
K994096 — SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEMSonosite,Inc.·Product code IYN·1999-12-20
K993115 — MULTITAK SSBonutti Research, Inc.·Product code MAI·1999-12-17
K993118 — BIOTEQUE A.V. FISTULA NEEDLE SETBioteque Corp.·Product code FIE·1999-12-17
K993123 — QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2BUnited Pacific Co., Ltd.·Product code ILY·1999-12-17
K993130 — ULTRA-GARMENT ELECTRODENewwave Medical, LLC·Product code GXY·1999-12-17
K993139 — YP 45/15-BP; YP 53/15-BP; YP 60/15-BPBiotronik, Inc.·Product code DTB·1999-12-17
K993153 — INTRALASE 600C LASER KERATOMEIntra Lase Corp.·Product code GEX·1999-12-17
K993157 — HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240Weck Closure Systems·Product code FZP·1999-12-17
K993202 — EIM-107 PREP-CHECKGeneral Devices·Product code GZO·1999-12-17
K993443 — RTD ARM ASSISTIVE ROBOTIC DEVICERehabilitation Technologies Division·Product code ITI·1999-12-17
K993926 — OMNIAXIAL CONNECTOROrtho Tec, LLC·Product code MNH·1999-12-17
K993967 — ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002Oratec Interventions, Inc.·Product code GEI·1999-12-17
K994010 — INNOVAQUARTZ GENERAL SHAPE LASER FIBERInnovaquartz·Product code GEX·1999-12-17
K991246 — FRUCTOSAMINE, MODEL FR 106-01A.P. Total Care, Inc.·Product code LCP·1999-12-16
K992111 — VERDICT -II OPIATES 2000Medtox Diagnostics, Inc.·Product code DJG·1999-12-16
K992552 — COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAYDiaSorin, Inc.·Product code LIP·1999-12-16
K992626 — SURE-WAY REUSABLE SHARPS CONTAINERSure-Way Systems, Inc.·Product code FMI·1999-12-16
K992676 — PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVESWear Safe Malaysia Sdn. Bhd.·Product code LYY·1999-12-16
K992681 — PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILEWear Safe Malaysia Sdn. Bhd.·Product code LYY·1999-12-16
K993033 — INTRAY GCBiomed Diagnostics, Inc.·Product code JTY·1999-12-16
K993327 — TALON ANCHOR SNAP-PAKMitek Products·Product code DZL·1999-12-16
K993333 — CLEARPLAN EASY II HOME PREGNANCY TESTUnipath , Ltd.·Product code LCX·1999-12-16
K993379 — PALL SUPOR AEF FILTERPall Corp.·Product code FPB·1999-12-16
K993468 — WAKO L-TYPE GOT TESTWako Chemicals USA, Inc.·Product code CIT·1999-12-16
K993571 — BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12Bayer Corp.·Product code CDD·1999-12-16
K993711 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS)Bayer Corp.·Product code JZG·1999-12-16
K993764 — MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCHMedipack Medical Packaging Mfg. Co.·Product code KCT·1999-12-16
K993835 — PARAPOST SYSTEM STERILIZABLE ORGANIZERColtene/Whaledent, Inc.·Product code FRG·1999-12-16
K993837 — AVL OPTI CRITICAL CARE ANALYZERAvl Scientific Corp.·Product code CGA·1999-12-16
K993952 — IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6Diagnostic Products Corp.·Product code LFZ·1999-12-16
K994093 — AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25CPhamatech·Product code LCL·1999-12-16
K990058 — QMS MAPPING SYSTEM,MODEL 2000Cathdata, Inc.·Product code DQK·1999-12-15
K991401 — ATR 3000, ATR 2000, IMPLANT-PROAdvanced Technology Research (A.T.R.) S.R.P.·Product code EFB·1999-12-15
K992631 — ACUNAV DIAGNOSTIC ULTRASOUND CATHETERAcuson Corp.·Product code DQO·1999-12-15
K993099 — BREMER HALO SYSTEM TITANIUM SKULL PINDepuyacromed·Product code JEC·1999-12-15
K993296 — TRIP TONOMETRY CATHETER, 14FDatex-Ohmeda, Inc.·Product code KNT·1999-12-15
K993413 — STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROLInvacare Corp.·Product code ITI·1999-12-15
K993423 — BACT/ALERT SAOrganon Teknika Corp.·Product code MDB·1999-12-15
K993530 — SYSTEM 2100Math Solutions, LLC·Product code LLZ·1999-12-15
K993532 — DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES)Impax Technology, Inc.·Product code LLZ·1999-12-15
K993539 — DCI ENDOSCOPEKARL STORZ Endoscopy-America, Inc.·Product code GWG·1999-12-15
K993594 — CONFORMAX MMLC VR1Radionics, Inc.·Product code IYE·1999-12-15
K993597 — PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617Vidar Systems Corp.·Product code LMA·1999-12-15

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