FDA 510(k) clearances — page 886

176,637 clearances on record, most recent first.

Clearances — page 886

88,501–88,600 of 176,637

K984257 — MEDRAD PHASED ARRAY NEUROVASCULAR COILMedrad, Inc.·Product code MOS·1999-01-25
K984273 — FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENSCiba Vision Corporation·Product code MVN·1999-01-25
K984274 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWAREHitachi Medical Systems America, Inc.·Product code LNH·1999-01-25
K984605 — POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED)Perusahaan Getah Asas Sdn. Bhd.·Product code LZA·1999-01-25
K990017 — ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10Bio-Rad·Product code JJY·1999-01-25
K990061 — VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERSOrtho-Clinical Diagnostics, Inc.·Product code JJX·1999-01-25
K983796 — 6004 NIBP MONITOR WITH TEMPERATUREBci Intl., Inc.·Product code DXN·1999-01-22
K983920 — EMS PEEP VALVES- ADJUSTABLEEngineered Medical Systems·Product code BYE·1999-01-22
K984181 — THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEMZeus Scientific, Inc.·Product code LFY·1999-01-22
K984232 — MODIFICATION OF EMIT D.A.U. OPIATES ASSAYSyva Co.·Product code DJG·1999-01-22
K984317 — THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FZeus Scientific, Inc.·Product code LGD·1999-01-22
K984321 — VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORSOrtho-Clinical Diagnostics, Inc.·Product code CDD·1999-01-22
K984577 — DRAGER OXYLOG 2000Drager, Inc.·Product code CBK·1999-01-22
K982114 — LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVESM/S Midland Latex Products , Ltd.·Product code LYY·1999-01-21
K982652 — ALLEGIANCE PORTA-WARM MATTRESSAllegiance Healthcare Corp.·Product code IMD·1999-01-21
K982771 — GYRUS HYSTEROSCOPIC RESECTOSCOPEGyrus Medical , Ltd.·Product code HIH·1999-01-21
K983593 — OVUM PICK-UP ASPIRATION NEEDLESCook Ob/Gyn·Product code MQE·1999-01-21
K983743 — BISURE LAPAROSCOPIC BIPOLAR FORCEPSValleylab, Inc.·Product code GEI·1999-01-21
K983744 — MCAS (MODULAR CLIP APPLIER SYSTEM)Applied Medical Resources·Product code DSS·1999-01-21
K983787 — SYNTHES PROXIMAL TIBIA PLATING SYSTEMSynthes (Usa)·Product code HRS·1999-01-21
K983828 — NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREESinetimed Latex Sdn Bhd·Product code LZA·1999-01-21
K983998 — POWDER FREE LATEX EXAMINATION GLOVESSri Anusham Rubber Industries Pvt., Ltd.·Product code LYY·1999-01-21
K984046 — BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENSOcular Sciences Puerto Rico, Inc.·Product code LPL·1999-01-21
K984200 — STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILER. Thomas Grotz, M.D., Inc.·Product code MBI·1999-01-21
K984243 — TELEX TINNITUS-COMPANIONTelex Communications, Inc.·Product code KLW·1999-01-21
K984259 — PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)Cl-Tinters·Product code LPL·1999-01-21
K984362 — ENLIGHT LVSybron Dental Specialties, Inc.·Product code DYH·1999-01-21
K984377 — SYNTHES SPINE CERVIFIX SYSTEMSynthes (Usa)·Product code KWP·1999-01-21
K990132 — DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TECDatex-Ohmeda, Inc.·Product code CAD·1999-01-21
K982006 — MICOMED - HALM ZIELKE INSTRUMENTATIONMicomed GmbH·Product code KWQ·1999-01-20
K982332 — STERIS TEN SIXTEEN STEAM STERILIZERSTERIS Corporation·Product code FLE·1999-01-20
K982532 — PARIETEXCogent·Product code FTL·1999-01-20
K982997 — FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER)Aspect Vision Care, Ltd.·Product code LPL·1999-01-20
K983217 — ROWE DUAL-CHECK VALVECook, Inc.·Product code FPA·1999-01-20
K983647 — ECHO-COAT ULTRASOUND NEEDLESSts Biopolymers·Product code MJG·1999-01-20
K983727 — BIOSONIC ULTRASONIC SCALER SYSTEMColtene/Whaledent, Inc.·Product code ELC·1999-01-20
K983926 — MPS GRAVITY FLOW CONTROL SETCritical Device Corp.·Product code FPA·1999-01-20
K984122 — WAKO L-TYPE UIBC, WAKO UIBC CALIBRATORWako Chemicals USA, Inc.·Product code JQF·1999-01-20
K984147 — LOVYTEX SND BHD POWDER-FREE POLYMER COATED LATEX EXAMINATION GLOVESLovytex Sdn Bhd·Product code LYY·1999-01-20
K984217 — ENLIGHT-2Sybron Dental Specialties, Inc.·Product code DYH·1999-01-20
K984331 — ODI ULTIMATE COMPRESSION HIP SCREWOrthopedic Designs, Inc.·Product code HWC·1999-01-20
K984348 — TIMX LOW BACK SYSTEMDepuy Motech Acromed·Product code MNI·1999-01-20
K984350 — VSP SYSTEMDepuy Motech Acromed·Product code MNI·1999-01-20
K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORBoehringer Mannheim Corp.·Product code JIX·1999-01-20
K984484 — LC MICROHYBRIDS & C Polymer GmbH·Product code EBF·1999-01-20
K984517 — CYNOSURE ERASURE LASERCynosure, Inc.·Product code GEX·1999-01-20
K982515 — POWER-DRIVE, WISAP MODEL #7688PD/7688PD1Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh·Product code HET·1999-01-19
K982875 — MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEMDanek Medical, Inc.·Product code KWQ·1999-01-19
K983527 — MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPEDofi Technologies, Inc.·Product code GCJ·1999-01-19
K983739 — OPTUM, INTRAORAL CAMERA SYSTEMCamsight, Inc.·Product code EIA·1999-01-19
K984027 — EBI SPINELINK SYSTEMElectro-Biology, Inc.·Product code MNI·1999-01-19
K984028 — THE NEW BIO-MOORE ENDO HEADSBiomet, Inc.·Product code KWL·1999-01-19
K984170 — THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEMZeus Scientific, Inc.·Product code LGD·1999-01-19
K984451 — D-SIGN I (R&D PROJECT DW263 #24)Ivoclar North America, Inc.·Product code EJS·1999-01-19
K984457 — WORLD CLASS WHEELED CHAIR, MODEL SSSuiter Medical LLC·Product code IOR·1999-01-19
K984612 — SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMSynthes Spine·Product code MNI·1999-01-19
K983673 — LASETTECell Robotics, Inc.·Product code GEX·1999-01-15
K983678 — ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLEElekta Instruments, Inc.·Product code JAI·1999-01-15
K983689 — BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODESMedicotest A/S·Product code DRX·1999-01-15
K984119 — WAKO L-TYPE FE, WAKO L-TYPE CALIBRATORWako Chemicals USA, Inc.·Product code CFM·1999-01-15
K982058 — ROTECNO FR (FLUID RESISTANT) SURGICAL GOWNEncompass Group, LLC·Product code FYA·1999-01-14
K982228 — FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25Tz Medical, Inc.·Product code DXH·1999-01-14
K982329 — VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)Endosonics Corp.·Product code ITX·1999-01-14
K982334 — AIRZONE PEAK FLOWMETERClement Clarke Intl., Ltd.·Product code BZH·1999-01-14
K982518 — AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh·Product code HET·1999-01-14
K982630 — MEDWORKS VISUALIZATION INSEMINATION CATHETERMedworks Corp.·Product code MFD·1999-01-14
K982805 — INTROCAN SAFETY IV CATHETERB.Braun Medical, Inc.·Product code FOZ·1999-01-14
K983223 — DENTAL STERLIZATION TRAY/CASSETTEBrasseler USA I, L.P.·Product code FRG·1999-01-14
K983570 — GLOVE SEAL D'PRO LATEX EXAMINATION GLOVEGlove Seal Sdn Bhd·Product code LYY·1999-01-14
K983670 — STEALTHSTATION SYSTEMSurgical Navigation Technologies, Inc.·Product code HAW·1999-01-14
K983683 — UNIK TONGUE CLEANERUnik Products, Inc.·Product code LCN·1999-01-14
K983814 — GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEMEfratgo, Ltd. HI Tech Bio-Surgical·Product code JDO·1999-01-14
K983815 — PACSCACHEDome Imaging Systems, Inc.·Product code LLZ·1999-01-14
K983827 — MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREESinetimed Latex Sdn Bhd·Product code LYY·1999-01-14
K983889 — HYS-SURGIFLATOR 150PW.O.M. World of Medicine GmbH·Product code HIG·1999-01-14
K984094 — VINYL EXAMINATION GLOVES, PREPOWDERED USPTrans Ancient Products Co., Ltd.·Product code LYZ·1999-01-14
K984172 — MODIFICATION OF PURESPERMNidacon International AB·Product code MQL·1999-01-14
K984524 — AZTECH 70Villa Sistemi Medicali S.P.A.·Product code EHD·1999-01-14
K984541 — GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEADDePuy Orthopaedics, Inc.·Product code KWT·1999-01-14
K984553 — TALKING DIGITAL THERMOMETER, MODEL KV-171K-Jump Health Co., Ltd.·Product code FLL·1999-01-14
K984575 — MULTI-PURPOSE DISINFECTING SOLUTION ID 90746Alcon Laboratories·Product code LPN·1999-01-14
K981173 — CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)Precision Biologicals, Inc.·Product code GJT·1999-01-13
K981174 — CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)Precision Biologicals, Inc.·Product code GJT·1999-01-13
K982062 — CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10Precision Biologicals, Inc.·Product code GGW·1999-01-13
K982115 — LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORYRim-Wide Companies, Inc.·Product code LYL·1999-01-13
K982419 — HEART-LIFT BALLOON POSITIONERCardiothoracic Systems, Inc.·Product code MWS·1999-01-13
K982485 — SERAQUEST CMV IGMQuest Intl., Inc.·Product code LFZ·1999-01-13
K982570 — SNN SCOUTI.S.G. Technologies, Inc.·Product code HAW·1999-01-13
K982957 — SENSIFLEX POWDERFREE SURGEON'S GLOVETerang Nusa Sdn Bhd·Product code KGO·1999-01-13
K983544 — VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.)Vygon Corp.·Product code LJS·1999-01-13
K983772 — MB/BACT BLOOD CULTURE BOTTLEOrganon Teknika Corp.·Product code MDB·1999-01-13
K984036 — NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1999-01-13
K984040 — BLOSSOM POWDERED LATEX EXAMINATION GLOVESMexpo Intl., Inc.·Product code LYY·1999-01-13
K984066 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIMOmni Intl., Inc.·Product code KGO·1999-01-13
K984067 — STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAKDade Behring, Inc.·Product code JHX·1999-01-13
K984140 — MAINBOND AJ.F. Jelenko & Co., Inc.·Product code EJT·1999-01-13
K984184 — WAKO L-TYPE AMYLASEWako Chemicals USA, Inc.·Product code JFJ·1999-01-13
K984361 — ORAL-EZE ORAL FLUID COLLECTION SYSTEMOsborn Laboratories, Inc.·Product code PJD·1999-01-13
K984387 — R-30 AESTHETIC RESTORATIVEDentsply Intl.·Product code EBF·1999-01-13
K984485 — MICROSTAT 2Chemlink Laboratories, LLC·Product code LRJ·1999-01-13

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