FDA 510(k) clearances — page 1212

176,637 clearances on record, most recent first.

Clearances — page 1212

121,101–121,200 of 176,637

K910884 — CARD GUARD, MODELS CG-6000 & CG-7000Card Guard Scientific Survival , Ltd.·Product code DSH·1991-10-16
K911455 — MODEL #100 SHOCK-TRODE CHILD DEFIB PADSCardiotronics, Inc.·Product code LDD·1991-10-16
K911456 — MODEL #110 STEALTH-TRODE CHILD DEFIB PADSCardiotronics, Inc.·Product code LDD·1991-10-16
K911869 — IVT GUIDING CATHETERIntensive Technology, Inc.·Product code DQY·1991-10-16
K912063 — POLARIS, ORAL INDICATIONPfizer Laser Systems·Product code GEX·1991-10-16
K912621 — MODEL #911 STEALTH MULTI PADSCardiotronics, Inc.·Product code LDD·1991-10-16
K913191 — DORNIER LASER LITHOTRIPTER IMPACTDornier Medtech America, Inc.·Product code GEX·1991-10-16
K913193 — MODEL 100 CENTRAL STATIONProtocol Systems, Inc.·Product code DQK·1991-10-16
K913600 — WRISTRECORDER CARDIAC EVENT RECORDING SYSTEMRalin Laboratories, Inc.·Product code DSH·1991-10-16
K913689 — SUB-4(TM), PERIPHERAL DILATATION CATHETERBoston Scientific Corp·Product code LIT·1991-10-16
K913801 — CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VALCordis Corp.·Product code DYB·1991-10-16
K904360 — CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATORMaximum Performance Technologies, Mpts, Inc.·Product code IPF·1991-10-15
K905672 — TEAM-MCHenley Intl.·Product code GZJ·1991-10-15
K910421 — SATURATION/HEMATOCRIT MONITOR SYSTEMMedtronic Vascular·Product code DRY·1991-10-15
K910970 — MARKSMAN ARTERIAL BLOOD GAS SYRINGEMartech Medical Products, Inc.·Product code JKA·1991-10-15
K911598 — DATASCOPE PASSPORT MONITORDatascope Corp.·Product code DRT·1991-10-15
K911750 — COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIEDMedical Instrumentation & Diagnostics Corp.(Midco)·Product code IYE·1991-10-15
K911770 — OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEMAutomatic Liquid Packaging, Inc.·Product code BTT·1991-10-15
K911814 — AXION 5, MODIFICATIONVentura Medical Electronics·Product code GZJ·1991-10-15
K911888 — PHILIPS ANGIOPROPhilips Medical Systems North America, Inc.·Product code IZP·1991-10-15
K911983 — WIZARD STERILIZED ELECTROEPILATION NEEDLESkin Deep, Inc.·Product code KCW·1991-10-15
K912033 — ULTRASOUND STETHOSCOPE(R) INTRADOP(R)Medadonics, Inc.·Product code JAF·1991-10-15
K912412 — VITALOGRAPH SPIROTRAC IIIVitalograph , Ltd.·Product code BZG·1991-10-15
K912684 — HOME MEDICAL KIT - FOR LITTLE HURTSGreat West Medical Equipment, Inc.·Product code MCY·1991-10-15
K912710 — TRUE/FLEX TIBIAL RODS WITH CAPApplied Osteo Systems, Inc.·Product code HSB·1991-10-15
K912763 — OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS)Medical Fittings, Inc.·Product code BYX·1991-10-15
K912933 — MEDICAM LAPAROSCOPY ENDOSCOPESKirschner Medical Corp.·Product code GCJ·1991-10-15
K913029 — GYROVIEW-HRPhilips Medical Systems, Inc.·Product code JAK·1991-10-15
K913148 — COLLAGEN SHIELD FOR ACUTE CAREVitaphore Corp.·Product code MOE·1991-10-15
K913189 — NIDEK MODEL NT-1000Nidek, Inc.·Product code HKX·1991-10-15
K913461 — FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEMNeoligaments, Ltd.·Product code JDR·1991-10-15
K913478 — RADIOGRAPHIC FILM MARKING SYSTEMLorad Medical Systems, Inc.·Product code JAC·1991-10-15
K913619 — CERAVITAL MIDDLE EAR IMPLANTFriedrichsfeld Medizintechnik AG·Product code ETB·1991-10-15
K913745 — DUCAL SIDE SHIELD SUNGLASSDucal Trading Corp.·Product code HQY·1991-10-15
K905211 — VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAYVitek Systems, Inc.·Product code LLH·1991-10-11
K910341 — POLARISPfizer Laser Systems·Product code GEX·1991-10-11
K910687 — GUARDIAN GEL, SURGEON'S GLOVING CREAMGuardian Angel Products, Inc.·Product code KGQ·1991-10-11
K911925 — POLARIS, GASTROENTEROLOGY/UROLOGY/PULMONARY, GI/GUPfizer Laser Systems·Product code GEX·1991-10-11
K912107 — GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MMW. L. Gore & Associates, Inc.·Product code DXZ·1991-10-11
K912255 — HYCOR PYLORAGEN HELICOBACTER PYLORI TESTHycor Biomedical, Inc.·Product code LYR·1991-10-11
K912330 — B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code FMF·1991-10-11
K912344 — MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESISDacomed Corp.·Product code FAE·1991-10-11
K912369 — HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)Biomet, Inc.·Product code MEH·1991-10-11
K912370 — HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)Biomet, Inc.·Product code MEH·1991-10-11
K912703 — OPTICA 60 ND; YAG SURGICAL LASER SYSTEMXintec Corporation·Product code GEX·1991-10-11
K913060 — NATURAL POROUS HIP SYSTEMIntermedics Orthopedics·Product code JDI·1991-10-11
K913188 — KINEMAX PLUS TIBIAL INSERTHowmedica Corp.·Product code JWH·1991-10-11
K913208 — APR II NON-POROUS HIP STEMIntermedics Orthopedics·Product code JDI·1991-10-11
K913221 — TYPE FA10 AUDIOMETERFrye Electronics, Inc.·Product code EWO·1991-10-11
K913225 — URINE/CSF MICROPROTEIN REAGENTIntersect Systems, Inc.·Product code CEK·1991-10-11
K913307 — ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21Em Diagnostic Systems, Inc.·Product code CIG·1991-10-11
K913456 — VISI-NEISSERIAKev Connecticut Diagnostics, Inc.·Product code JSX·1991-10-11
K913506 — CONVERTORS SAFECARE GOWN & DRAPE MATERIALBaxter Healthcare Corp·Product code KKX·1991-10-11
K913864 — PCP DIRECT RIA KIT (I-125)Immunalysis Corporation·Product code LCL·1991-10-11
K913927 — IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYSTInstrumentation Laboratory CO·Product code CHL·1991-10-11
K914129 — DIFF SAFEMarshall Levinson·Product code JKA·1991-10-11
K914146 — BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSEBiosite Incorporated·Product code DKZ·1991-10-11
K914202 — BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGEBaxter Diagnostics, Inc.·Product code JJQ·1991-10-11
K914253 — PROCLINIC ONE STEP PREGNANCY TESTVanguard Biomedical Corp.·Product code JHI·1991-10-11
K914262 — ABBOTT QUICKSTART LDH,#5A31Em Diagnostic Systems, Inc.·Product code CFJ·1991-10-11
K914303 — TARGET(TM)-HOGV-Tech, Inc.·Product code JHI·1991-10-11
K914333 — SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTIONSiemens Hearing Instruments, Inc.·Product code ESD·1991-10-11
K902920 — TURBOTRON 20/20Prestige Manufacturing Snd Bhd·Product code LYL·1991-10-10
K911472 — BIO-SENSOR 01 EKG ELECTRODEBio-Sensor, Inc.·Product code DRX·1991-10-10
K911662 — MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADSMarquette Electronics, Inc.·Product code LDD·1991-10-10
K911687 — VER-MED A10020 RESTING EKG ELECTRODEVermont Medical, Inc.·Product code DRX·1991-10-10
K912265 — MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000Medical Laser, Inc.·Product code FED·1991-10-10
K912382 — MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130Continental X-Ray Corp.·Product code IXQ·1991-10-10
K912652 — FLEX-ELBOWVital Signs, Inc.·Product code BZA·1991-10-10
K913028 — ARTHRO-FLOW IRRIGATION 2 SYSTEMDavol, Inc.·Product code HRX·1991-10-10
K913110 — PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIEDMicrowave Medical Systems, Inc.·Product code DRQ·1991-10-10
K913220 — AEROSOL MASKS, 81426, 81476, 81490 & 81492Specialty Packaging Producs, Inc.·Product code CAF·1991-10-10
K913263 — VITALMAX 830 SERIESPace Tech, Inc.·Product code MHX·1991-10-10
K913275 — VENTURI OXYGEN MASKSpecialty Packaging Producs, Inc.·Product code BYG·1991-10-10
K913297 — SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATHSchneider Intl., Ltd.·Product code LIT·1991-10-10
K913643 — MUCOUS SPECIMEN TRAPMedical Device Inspection Co., Inc.·Product code BYZ·1991-10-10
K913680 — BERMAN INTUBATING/PHARYNGEAL AIRWAYChain Plastics Operations, Inc.·Product code CAE·1991-10-10
K904747 — PEI PLAQUE ELECTRODE ARRAYPrucka Engineering, Inc.·Product code DRF·1991-10-09
K911043 — HEMISPHERE MULTIPLANE ENDORECTAL PROBEPie Medical Equipment B.V.·Product code ITX·1991-10-09
K911285 — PULPDENT POLYAMIDE DENTIN LINERPulpdent Corp.·Product code EME·1991-10-09
K911981 — HEMOCARD HEMOGLOBIN SIsolab, Inc.·Product code GHM·1991-10-09
K912008 — TRU-VIEW MULTI-CHANNEL DISPLAYGeneral Devices·Product code DRT·1991-10-09
K912050 — NOVOSTE VESSEL DILATERNovaste Corp.·Product code DRE·1991-10-09
K912160 — BUTTERFLY DRESSINGDurden Enterprises, Inc.·Product code KGX·1991-10-09
K912711 — IL TEST PROCLOT ASSAY STYSTEMInstrumentation Laboratory CO·Product code GGP·1991-10-09
K912876 — FIBRINOSTIKA FBDP MICROELISA SYSTEMOrganon Teknika Corp.·Product code DAP·1991-10-09
K913022 — CCI VIDEOKERATOSCOPE/COMPARATORCci·Product code HLQ·1991-10-09
K913025 — ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16Em Diagnostic Systems, Inc.·Product code CJW·1991-10-09
K913061 — FIBRINOGEN DETERMINATION KITSigma Diagnostics, Inc.·Product code GIS·1991-10-09
K913113 — FST CATH-UD CATHETER, MODIFICATIONFiberoptic Sensor Technlogies, Inc.·Product code FEN·1991-10-09
K913118 — GLAUCOMA-SCOPEOphthalmic Imaging Systems·Product code HLI·1991-10-09
K913535 — A-DEC DECADE 1020 CHAIRA-Dec, Inc.·Product code KLC·1991-10-09
K913572 — AUTOPACK NON-EUGENOL PERIODONTAL DRESSINGSpecialites Septodont·Product code EMA·1991-10-09
K913698 — ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIALHeraeus Kulzer, Inc.·Product code EBI·1991-10-09
K913699 — MODERN MATERIALS ORTHODONTIC RESINHeraeus Kulzer, Inc.·Product code EBI·1991-10-09
K913705 — ABBOTT QLUICKSTART IRON TEST, ITEM #5A29Em Diagnostic Systems, Inc.·Product code CFM·1991-10-09
K913789 — AEROBIC FOAM SWAB CULTURETTE(R)Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code JSM·1991-10-09
K913947 — IMPERVA BONDShofu Dental Corp.·Product code EBF·1991-10-09
K913978 — TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZEBeckman Instruments, Inc.·Product code CEK·1991-10-09
K914081 — ICAN COTTON RAYON BALLSIcn Pharmaceuticals, Inc.·Product code FRL·1991-10-09

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