FDA 510(k) clearances — page 922

176,637 clearances on record, most recent first.

Clearances — page 922

92,101–92,200 of 176,637

K980041 — CARESIDE ALBUMINExigent Diagnostics, Inc.·Product code CIX·1998-02-04
K980042 — CARESIDE TOTAL PROTEINExigent Diagnostics, Inc.·Product code CEK·1998-02-04
K980088 — T-UPTAKE MICROPLATE EIAMonobind·Product code KHQ·1998-02-04
K971756 — MEDTRONIC MODEL 3998 LEADMedtronic Vascular·Product code GZB·1998-02-03
K973066 — NON-REBREATHING 'T' (BE 117)Instrumentation Industries, Inc.·Product code CBP·1998-02-03
K973172 — RESPOSABLE BARE FIBERSTrimedyne, Inc.·Product code GEX·1998-02-03
K973596 — SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULESpacelabs Medical, Inc.·Product code OLW·1998-02-03
K974208 — TYTRON C-3000Titronics Research & Development Co.·Product code HCS·1998-02-03
K974233 — LYSONIX IRRIGATION SYSTEMLysonix, Inc.·Product code GBX·1998-02-03
K974320 — CRYOGEN CARDIAC CRYOSURGICAL SYSTEMCryogen, Inc.·Product code OCL·1998-02-03
K974553 — 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130)3M Healthcare·Product code GEI·1998-02-03
K980196 — MD TECH BIOPSY SET FOR BONE AND BONE MARROWMedical Device Technologies, Inc.·Product code KNW·1998-02-03
K972111 — RUMORS DYNAMIC AIR THERAPY UNITHill-Rom, Inc.·Product code IKZ·1998-02-02
K972119 — MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)Medovations, Inc.·Product code FAT·1998-02-02
K972630 — COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEMCooperSurgical, Inc.·Product code HEX·1998-02-02
K972657 — ULTRAMIST 2000Texas Medical Industries, Inc.·Product code CAF·1998-02-02
K974027 — AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACKAlfa Biotech (Uk) , Ltd.·Product code CDP·1998-02-02
K974163 — MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316Medtronic Minimed·Product code FPA·1998-02-02
K974357 — UTERINE MANIPULATOR/INJECTORCatheter Research, Inc.·Product code LKF·1998-02-02
K974413 — PERMAFLOUltradent Products, Inc.·Product code EBF·1998-02-02
K974458 — COMPOLUTE APLICAPEspe Dental-Medizin GmbH & Co.Kg.·Product code EMA·1998-02-02
K974508 — DBEST ONE-STEP OVULATION TESTAmeritek, Inc.·Product code CEP·1998-02-02
K974607 — RANDOX CALCIUMRandox Laboratories, Ltd.·Product code CJY·1998-02-02
K980028 — ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.·Product code CKA·1998-02-02
K970119 — MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIXMitek Products·Product code MBI·1998-01-30
K970445 — VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300Pace Tech Medical Monitors, Inc.·Product code MHX·1998-01-30
K971965 — PHILIPS EASYVISIONPhilips Medical Systems, Inc.·Product code LLZ·1998-01-30
K972157 — EXCEL AV STIM 1000Excel Tech. , Ltd.·Product code GWJ·1998-01-30
K972298 — ETB TELESCOPE W/WORKING CHANNEL FOR SEPSThe Altomec Corp.·Product code GCJ·1998-01-30
K973499 — XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEMXomed, Inc.·Product code HRX·1998-01-30
K973504 — UROSURGE UROSTENTPrinceton Regulatory Assoc.·Product code FAD·1998-01-30
K973516 — CAPIOX HEMOCONCENTRATORTerumo Medical Corp.·Product code KDI·1998-01-30
K973701 — SOMNUS TISSUE COAGULATING ELECTRODESomnus Medical Technologies, Inc.·Product code GEI·1998-01-30
K973814 — TRUMP-IT II AND MAGNUM 250Valley West, Inc.·Product code GCJ·1998-01-30
K974126 — IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREWImcor·Product code DZE·1998-01-30
K974136 — CRANIOFACIAL ANCHORSBiomet, Inc.·Product code MBI·1998-01-30
K974137 — UROMED NEEDLE GRASPERUromed Corp.·Product code OCW·1998-01-30
K974138 — ROCKET ELECTRODEA & A Medical, Inc.·Product code HGI·1998-01-30
K974279 — 3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C)3M Healthcare·Product code GEI·1998-01-30
K974303 — INFANT FLOW SYSTEMSensor Medics Corp.·Product code BZD·1998-01-30
K974309 — LACTOSORB PANELSBiomet, Inc.·Product code HRS·1998-01-30
K974328 — ADVANCE TOTAL KNEE SYSTEMWrightmedicaltechnologyinc·Product code JWH·1998-01-30
K974391 — KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEMKarl Storz Imaging, Inc.·Product code GCJ·1998-01-30
K974392 — LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEMBiovision GmbH·Product code DZL·1998-01-30
K974440 — IBIGallini U.S., LLC·Product code KNW·1998-01-30
K974577 — COMPOGLASS FLOWIvoclar North America, Inc.·Product code EBF·1998-01-30
K974777 — VINYL EXAMINATION GLOVES POWDER FREESun Flower Gloves Co., Ltd.·Product code LYZ·1998-01-30
K974825 — BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUSBoehringer Mannheim Corp.·Product code JIX·1998-01-30
K974852 — NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.·Product code HQY·1998-01-30
K974858 — PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30Diagnostic Chemicals , Ltd.·Product code CEO·1998-01-30
K974860 — NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.·Product code HQY·1998-01-30
K974886 — POWDERED GREEN NITRILE EXAMINATION GLOVESSri Johani Sdn. Bhd.·Product code LZA·1998-01-30
K980005 — MANAN D BAGMedical Device Technologies, Inc.·Product code EXF·1998-01-30
K980030 — AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.·Product code CIT·1998-01-30
K980122 — MANAN SOFT TISSUE BIOPSY NEEDLESMedical Device Technologies, Inc.·Product code KNW·1998-01-30
K980137 — WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC·Product code LRO·1998-01-30
K971369 — BROWNE MVI STEAM INDICATORAlbert Browne , Ltd.·Product code JOJ·1998-01-29
K971670 — 3 CHANNEL DIGITAL AMBULATORY ECG RECORDERGalix Biomedical Instrumentation, Inc.·Product code DSH·1998-01-29
K972935 — SUPER-DENT INTERMEDIATE RESTORATIVE MATERIALS.S. White Mfg., Ltd.·Product code EMA·1998-01-29
K973104 — NORLAND MODEL PDEXA BONE DENSITOMETERNorland Corp.·Product code KGI·1998-01-29
K973106 — GOLEMB DISPOSABLE BAG MASK RESUSCITATORAllied Healthcare Products, Inc.·Product code BTM·1998-01-29
K973267 — TTM5000 TELEPHONIC EKG MONITORHds Medical, Inc.·Product code DXH·1998-01-29
K973792 — EASYSAFE RETRACTING NEEDLE SYRINGESaf-T-Med, Inc.·Product code MEG·1998-01-29
K973981 — SAFEPASS STERILIZATION POUCHAdroit Medical Systems, Inc.·Product code KCT·1998-01-29
K974112 — VACUDAP, MODEL 2000, 2001Victoreen, Inc.·Product code KPR·1998-01-29
K974121 — LUBRICATED BAGGY TACTYLON CONDOMSensicon Corp.·Product code MOL·1998-01-29
K974130 — VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWAREDejarnette Research Systems·Product code LMD·1998-01-29
K974231 — POSITION PENTA, POSITION PENTA QUICKEspe GmbH & Co. Kg.·Product code ELW·1998-01-29
K974282 — VITALESCENCEUltradent Products, Inc.·Product code EBF·1998-01-29
K974283 — PQ 1Ultradent Products, Inc.·Product code KLE·1998-01-29
K974288 — ZEROWET SPLASHIELDZerowet, Inc.·Product code KYZ·1998-01-29
K974356 — SURGEON'S GLOVESAmerican Health Products, Inc.·Product code KGO·1998-01-29
K974486 — CLEARFIL LINER BOND 2VKuraray America, Inc.·Product code KLE·1998-01-29
K974704 — HYDROGUMZhermack S.P.A.·Product code ELW·1998-01-29
K974887 — POWDERFREE GREEN NITRILE EXAMINATION GLOVESSri Johani Sdn. Bhd.·Product code LZA·1998-01-29
K980149 — POWDERED NITRILE EXAMINATION GLOVESMasju Sdn. Bhd.·Product code LZA·1998-01-29
K970333 — BACTEC MYCO/F LYTIC CULTURE VIALSBecton Dickinson Microbiology Systems·Product code MDB·1998-01-28
K971636 — RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1998-01-28
K971829 — MIS ELECTROSURGICAL ELECTRODEE-Tek, Inc.·Product code GEI·1998-01-28
K972605 — EMS NASAL CPAP MASKEngineered Medical Systems·Product code BZD·1998-01-28
K972989 — STC METHAMPHETAMINE MICRO-PLATE EIAOraSure Technologies, Inc.·Product code DKZ·1998-01-28
K973119 — FOUNDATION POROUS ACETABULAR SYSTEMEncore Orthopedics, Inc.·Product code LPH·1998-01-28
K974093 — FOUNDATION POROUS COATED HEMISPHERICAL SHELLEncore Orthopedics, Inc.·Product code LPH·1998-01-28
K974095 — FOUNDATION POROUS COATED FLARED RIM SHELLEncore Orthopedics, Inc.·Product code LPH·1998-01-28
K974098 — PUBOUURETHRAL SLINGETHICON, Inc.·Product code OTN·1998-01-28
K974119 — DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)Jack'S Electrodes·Product code GXZ·1998-01-28
K974139 — LQUET CANNULA/TROCAR SYSTEMLifequest Endoscopic Technologies, Inc.·Product code GCJ·1998-01-28
K974142 — HM-RUBYAmerican Lasers, Inc.·Product code GEX·1998-01-28
K974146 — PARACENTESIS CATHETER DEVICEAllegiance Healthcare Corp.·Product code GCB·1998-01-28
K974193 — NARKOMED ULTRASONIC FLOW SENSORDraeger Medical, Inc.·Product code BSZ·1998-01-28
K974552 — DIAMEDIX IS-MEASLES IGG TEST SYSTEMDiamedix Corp.·Product code LJB·1998-01-28
K974762 — STAT TRACKSAwareness Technology, Inc.·Product code JJQ·1998-01-28
K980055 — CARESIDE GLOBULINExigent Diagnostics, Inc.·Product code JGE·1998-01-28
K980135 — QUALICHECK5+ MODELS S7730, S7740, S7750, S7760Radiometer America, Inc.·Product code JJS·1998-01-28
K963903 — BIOSPECTROMETER-NB OXIMETER IIIIHutchinson Technology, Inc.·Product code MUD·1998-01-27
K965106 — ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606Biotronik, Inc.·Product code DTB·1998-01-27
K973037 — N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000Avid N.I.T., Inc.·Product code IWJ·1998-01-27
K973506 — ACTIVATOR IIActivator Methods, Inc.·Product code LXM·1998-01-27
K974085 — COBE OXYGENATOR PRODUCTSCobe Cardiovascular, Inc.·Product code DTZ·1998-01-27
K974134 — X-SIGHT DIGITAL IMAGING SYSTEMStallion Technologies, Inc.·Product code LLZ·1998-01-27

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