FDA 510(k) clearances — page 864

176,637 clearances on record, most recent first.

Clearances — page 864

86,301–86,400 of 176,637

K990762 — ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)Zoll Medical Corp·Product code MKJ·1999-09-03
K990979 — STECO-TITANMAGNETICSSteco-System-Technik GmbH & Cokg·Product code EGG·1999-09-03
K991159 — PRISMATHERM II, ASTOLINEStihler Electronic GmbH·Product code BSB·1999-09-03
K991180 — BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEMZeus Scientific, Inc.·Product code LSR·1999-09-03
K991185 — BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEMZeus Scientific, Inc.·Product code LSR·1999-09-03
K991274 — MUMPS IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.·Product code LJY·1999-09-03
K991910 — LIFEPAK 12 BIPHASICPhysio-Control Corp.·Product code MKJ·1999-09-03
K991915 — MODULAR RADIAL HEADWrightmedicaltechnologyinc·Product code KWI·1999-09-03
K991946 — ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505LSterilex Corp.·Product code EIA·1999-09-03
K991966 — THE NOMOS CHANE IINomos Corp.·Product code IYE·1999-09-03
K991973 — CAPIOX SX10 HARDSHELL RESEVOIRTerumo Medical Corp.·Product code DTN·1999-09-03
K991979 — SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321Medtronic Minimed·Product code FPA·1999-09-03
K992005 — GILTECH PLUS TRANSPARENT DRESSINGGiltech Plus, Inc.·Product code MGP·1999-09-03
K992023 — GRAND CERAMNoritake Co., Inc.·Product code EIH·1999-09-03
K992063 — OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOYHowmedica Osteonics Corp.·Product code HSB·1999-09-03
K992077 — PASCO MIC AND MIC/ID PANELS (OFLOXACIN)Pasco Laboratories, Inc.·Product code JTN·1999-09-03
K992088 — BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGenzyme Surgical Product (Genzyme Biosurgery)·Product code GAM·1999-09-03
K992108 — PASCO MIC AND MIC/ID PANELS (CEFEPIME)Pasco Laboratories, Inc.·Product code JWY·1999-09-03
K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400CPacific Hemostasis·Product code KQG·1999-09-03
K992137 — UROLOGICAL CATHETERApogee, Inc.·Product code GBM·1999-09-03
K992166 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.·Product code LGC·1999-09-03
K992193 — ENDO-ESOPHAGEAL MR COILSurgi-Vision, Inc.·Product code MOS·1999-09-03
K992246 — QCT BONE MINERAL ANALYSIS SOFTWAREImage Analysis, Inc.·Product code KGI·1999-09-03
K992280 — LORAD 1-650 (INTERNATIONAL 650)Lorad Corp.·Product code IZH·1999-09-03
K992297 — PASCO MIC AND MIC/ID PANELS, LEVOFLOXACINPasco Laboratories, Inc.·Product code JTN·1999-09-03
K992400 — BACTALERT FAOrganon Teknika Corp.·Product code MDB·1999-09-03
K992401 — BACT/ALERT PFOrganon Teknika Corp.·Product code MDB·1999-09-03
K992576 — URINE CHEMISTRY CONTROL, LEVEL 1Consolidated Technologies, Inc.·Product code JJW·1999-09-03
K992578 — URINE CHEMISTRY CONTROL, LEVEL 2Consolidated Technologies, Inc.·Product code JJW·1999-09-03
K992659 — O2N DEMAND-II, VICTOR MODEL OCPR-IIThermadyne Holings Corp.·Product code NFB·1999-09-03
K992677 — EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000WHologic, Inc.·Product code KGI·1999-09-03
K992753 — CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEMVarian Assoc., Inc.·Product code MUJ·1999-09-03
K992896 — DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)Dental X-Ray Support Systems, Inc.·Product code EGY·1999-09-03
K990867 — RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18Advanced Cardiovascular Systems, Inc.·Product code FGE·1999-09-02
K991112 — SAGE CONTRAST MANAGEMENT SYSTEMSage Laboratories, Inc.·Product code FPA·1999-09-02
K991160 — ASTOTHERM PLUS, ASTOTUBES, ASTOLINEStihler Electronic GmbH·Product code BSB·1999-09-02
K991761 — MAGNESIUM PRODUCT NO'S, 112-01, 112-02A.P. Total Care, Inc.·Product code JGJ·1999-09-02
K991762 — ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02A.P. Total Care, Inc.·Product code CJE·1999-09-02
K991923 — SOOTHE-N-SEAL CANKER SORE RELIEFClosure Medical Corp.·Product code MZW·1999-09-02
K991948 — DR. B'S MOUTHPIECE, MODEL 32129-10002Snore - Ezzer·Product code LRK·1999-09-02
K992172 — LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580Bio-Rad·Product code JJY·1999-09-02
K992748 — DRUGCHECK X MULTIDRUG SCREENING DEVICESyntron Bioresearch, Inc.·Product code DIO·1999-09-02
K974387 — PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATUREMicrowave Medical Systems, Inc.·Product code KDJ·1999-09-01
K990338 — NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMPhysio-Control Corp.·Product code DXN·1999-09-01
K990412 — CUFF-ABLE PLUSVital Signs, Inc.·Product code DXQ·1999-09-01
K990592 — INTRASTENT IIIntratherapeutics, Inc.·Product code FGE·1999-09-01
K990873 — DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USEAmeritek, Inc.·Product code JMT·1999-09-01
K991899 — NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIESNihon Kohden America, Inc.·Product code GWF·1999-09-01
K991905 — COROMETRICS MODEL 171 AND 172 FETAL MONITORGeneral Electric Medical Systems Information Techn·Product code HGM·1999-09-01
K991922 — DIGITAL IMAGING SYSTEM (BSR)Siemens Medical Solutions USA, Inc.·Product code IZI·1999-09-01
K991963 — PATTON SPECULUMPatton Medical Corp.·Product code HIB·1999-09-01
K992078 — VANTAGE EXSPECT IIAdac Laboratories·Product code KPS·1999-09-01
K992103 — C-QUESTWuestec Medical, Inc.·Product code OWB·1999-09-01
K992190 — CORE POUCHCore Dynamics, Inc.·Product code GCJ·1999-09-01
K992301 — REUNITE SCREWSBiomet Manufacturing, Inc.·Product code HWC·1999-09-01
K992535 — ENDIUS SUCTION/IRRIGATION INSTRUMENTEndius, Inc.·Product code OCX·1999-09-01
K992545 — TM-300 TRACTION SYSTEMIto Co., Ltd.·Product code ITH·1999-09-01
K992570 — UNITRAX C-TAPER NECK ADJUSTMENT SLEEVEHowmedica Osteonics Corp.·Product code KWL·1999-09-01
K992761 — SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEMMedison America, Inc.·Product code IYO·1999-09-01
K992773 — CERALAS D10 810NM DIODE LASERCeram Optec, Inc.·Product code GEX·1999-09-01
K992808 — A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSUREA&D Medical Div.·Product code DXN·1999-09-01
K992818 — OPTIMAX/ COMPACT 2Protec GmbH & Co. KG·Product code IXW·1999-09-01
K990478 — CARD GUARD, MODEL CG-6550Card Guard Scientific Survival , Ltd.·Product code DXH·1999-08-31
K990487 — EQUINOX OCCLUSION BALLOON SYSTEMMicro Therapeutics, Inc.·Product code MJN·1999-08-31
K990536 — O.B. TAMPONPersonal Products Co.·Product code HEB·1999-08-31
K991777 — LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)Seltom Pacific Sdn. Bhd.·Product code LYY·1999-08-31
K991778 — LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)Seltom Pacific Sdn. Bhd.·Product code LYY·1999-08-31
K991904 — MODIFICATION OF JMS NEEDLES AND JMS SYRINGESJms Co., Ltd.·Product code FMI·1999-08-31
K992102 — LUMA LIGHT 2000 CURE LIGHTLumalite, Inc.·Product code EBF·1999-08-31
K992569 — MEDTRONIC AVE BRIDGE STENTMedtronic Ave, Inc.·Product code FGE·1999-08-31
K992636 — HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331AHewlett-Packard Co.·Product code DXJ·1999-08-31
K990271 — ENDOSONICS TRAK BACK DEVICEEndosonics Corp.·Product code DQX·1999-08-30
K990310 — CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)Charter Medical, Ltd.·Product code CAK·1999-08-30
K990470 — JMS A. V. FISTULA NEEDLE SETJms Co., Ltd.·Product code FIE·1999-08-30
K990510 — JMS APHERESIS NEEDLEJms Co., Ltd.·Product code FIE·1999-08-30
K991237 — XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNLRadionics, Inc.·Product code MUJ·1999-08-30
K991437 — WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00Wells Johnson Co.·Product code FRN·1999-08-30
K991851 — RENACLEAR DIALYZER CLEANING SYSTEMMinntech Corp.·Product code LIF·1999-08-30
K992059 — PASCO MIC AND MIC/ID PANELSPasco Laboratories, Inc.·Product code JWY·1999-08-30
K992066 — REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEMGE Medical Systems·Product code KPR·1999-08-30
K992076 — PASCO MIC AND MIC/ID PANELS (CEFUROXIME)Pasco Laboratories, Inc.·Product code JTN·1999-08-30
K992162 — SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIMSafeskin Corp.·Product code LZC·1999-08-30
K992164 — TELEMEDICINE 2000Card Guard Scientific Survival , Ltd.·Product code DXH·1999-08-30
K992223 — HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVEPamitex Industries Sdn Bhd·Product code LZA·1999-08-30
K992224 — VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KITHemagen Diagnostics, Inc.·Product code MSV·1999-08-30
K992241 — VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KITHemagen Diagnostics, Inc.·Product code MSV·1999-08-30
K992243 — VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KITHemagen Diagnostics, Inc.·Product code MSV·1999-08-30
K992357 — EASY-CURE (CURING AND WHITENING LIGHT)Ics of North America, Inc.·Product code EBZ·1999-08-30
K992430 — CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3Medical Analysis Systems, Inc.·Product code JJT·1999-08-30
K992463 — SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVESShijiazhuang Dilly Plastics Products Co., Ltd.·Product code LYZ·1999-08-30
K992483 — MEDIFIX INC.Medifix, Inc.·Product code FAJ·1999-08-30
K992596 — TOF-WATCH SOrganon Teknika Corp.·Product code KOI·1999-08-30
K992598 — TOF-WATCH SXOrganon Teknika Corp.·Product code KOI·1999-08-30
K981677 — REPOSE BONE SCREW SYSTEMInfluence, Inc.·Product code LRK·1999-08-27
K982208 — IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETERJomed Imaging , Ltd.·Product code ITX·1999-08-27
K983798 — SEDATELEC ASP ACUPUNCTURE NEEDLESSedatelec·Product code MQX·1999-08-27
K983800 — DN ACUPUNTURE NEEDLESSedatelec·Product code MQX·1999-08-27
K990261 — PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)Plus Orthopedics·Product code LZO·1999-08-27
K990766 — CERSR ELECTROMYOGRAPHY SYSTEMParaspinal Diagnostic Corp.·Product code IKN·1999-08-27
K990785 — TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTSJakoubek Medizintechnik GmbH·Product code GCJ·1999-08-27

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