Atlas FDA

1998

3,775 FDA 510(k) clearances · Clearance year

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RecordFirmDate
NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE) (K980729)Pt. Eka Wira Asia1998-04-02
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822 (K980224)Alexander Mfg. Co.1998-04-02
LATEX EXAMINATION GLOVE (K974660)Ideal Quality Sdn., Bhd.1998-04-02
TERUMO ALLERGY SYRINGE (K980796)Terumo Corp.1998-04-02
POWDER-FREE LATEX EXAMINATION GLOVE (K974662)Ideal Quality Sdn., Bhd.1998-04-02
TERUMO DISPOSABLE HYPODERMC SYRINGE (K980181)Terumo Medical Corp.1998-04-02
NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE) (K980807)Pt. Eka Wira Asia1998-04-02
IL TEST ANTITHROMBIN (K980499)Instrumentation Laboratory CO1998-04-02
NOVA LITE ENDOMYSIAL (K980312)Inova Diagnostics, Inc.1998-04-02
HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM (K980860)Atlantis Diagnostics Intl., Inc.1998-04-02
POWDERED LATEX EXAMINATION GLOVES (K980611)Servicom Services Sdn Bhd1998-04-02
COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE (K980168)Analogic Corp.1998-04-02
QUICKCARD PRO HCG TEST, MODEL 9008 (K980896)Phamatech1998-04-02
DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS (K980521)Bayer Corp.1998-04-02
EASYGO ASPIRATOR (K971749)Precision Medical, Inc.1998-04-01
QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131 (K980865)Phamatech1998-04-01
AEROSET SYSTEM (K980367)Abbott Laboratories1998-04-01
BIOLOG 3000 ELECTROCARDIOGRAPH (K974351)Micromedical, Inc.1998-04-01
ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 (K974002)Diagnostic Chemicals , Ltd.1998-04-01
ENDOBUTTON CONTINUOUS LOOP (K980155)Smith & Nephew, Inc.1998-04-01
BIPORE BALLOON DILATATION CATHETER (K973563)Bipore, Inc.1998-04-01
HTL MALE CONDOM (K980019)Reddy Medtech Health Products , Ltd.1998-04-01
LEKSELL GAMMAPLAN (K973441)Patterson Consulting Group, Inc.1998-04-01
SABRE BT BLUNT0TIP SURGICAL TROCAR (K980804)Endoscopic Concepts, Inc.1998-04-01
LIGHTSOURCE OR ILLUMINATOR (K980166)Cuda Products Co.1998-04-01
SCION BALLOON ELEVATOR (K973698)Scion International, Inc.1998-03-31
CARDIO-PAGER SYSTEM (K973527)Data Critical Corp.1998-03-31
UROMED PATCH (K974600)Uromed Corp.1998-03-31
LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND (K973684)Elekta Instrument AB1998-03-31
PEREGRINE SHIELDED DIFFUSION PROBE (K980027)Peregrine Surgical , Ltd.1998-03-31
PEREGRINE TAPERED DIFFUSION PROBE (K980025)Peregrine Surgical , Ltd.1998-03-31
CHASE FEMORAL ACCESS CANNULATION SET (K972993)Chase Medical, Inc.1998-03-31
FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES (K974493)Fiegert-Endotech Medizintechnik GmbH1998-03-31
COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET (K974897)Cobe Cardiovascular, Inc.1998-03-31
ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER (K980919)Fortune Medical Instrument Corp.1998-03-31
CARESIDE CREATININE (K980043)Exigent Diagnostics, Inc.1998-03-30
SILGEL TOPICAL GEL SHEET (K974172)Nagor , Ltd.1998-03-30
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 (K974210)Rad-Source, Inc.1998-03-30
CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS (K972992)Ceramatec, Inc.1998-03-30
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM (K980114)GE Medical Systems1998-03-30
JMS APHERESIS NEEDLE (K974902)Jms Co., Ltd.1998-03-30
FLOSI RIGID GAS PERMEABLE CONTACT LENS (K974636)Futuristic Design Assoc.1998-03-30
POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) (K980818)Stephen A. Dunn, Inc.1998-03-30
WINDMERE MODEL DS-2 FOOT BATH (K980769)Windmere Corp.1998-03-27
E3 MICROPROBE (K974878)Martin Uram, MD1998-03-27
DUOCLIPPER TITANIUM CLIPS (K973652)Scion International, Inc.1998-03-27
TRIANGLE SLING (K980482)Influence, Inc.1998-03-27
3 MM SELEC-TIP LAPAROSCOPIC SCISSORS (K980758)Microline Pentax, Inc.1998-03-27
BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW (K972919)Bionx Implants, Inc.1998-03-27
FOTONA SKINPLUS LASER SYSTEM (K980560)Fotona D.D.1998-03-27
SOFSILK SUTURE (K980124)United States Surgical, A Division of Tyco Healthc1998-03-27
KMC NEWSKIN (K974143)Kmc Intl. Co.1998-03-27
LASERSCOPE EL LASER SYSTEM AND ACCESSORIES (K974896)Laserscope1998-03-27
DRUG CHECK (K980153)Texas Immunology, Inc.1998-03-27
PHORESOR II, MODEL PM900 (K974855)Iomed, Inc.1998-03-27
CRANEX TOME CEPH, OR CRANEX TOME (K974877)Orion Corporation Soredex1998-03-27
PARA-CARE (K980718)Chattanooga Group, Inc.1998-03-27
TECA NCS ELECTRODE SYSTEM 2000 (K971914)Medelec, Inc. D.B.A. Teca Corp.1998-03-26
N-ASSAY CPK-L (K980900)Crestat Diagnostics, Inc.1998-03-26
EA-D IGG ELISA TEST SYSTEM (K973123)Clark Laboratories, Inc.1998-03-26
N-ASSAY L AST/GOT (K980902)Crestat Diagnostics, Inc.1998-03-26
ELECSYS CA 125II ON THE ELECSYS 1010 (K980240)Boehringer Mannheim Corp.1998-03-25
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR (K973419)Nellcor Puritan Bennett, Inc.1998-03-25
CROSS-CHECKS P (K972300)Steritec Products Mfg Co, Inc.1998-03-25
MEDI-GRIP (BEIGE 43)SURGICAL GLOVES (K980564)Ansell Perry1998-03-25
AFFINITY MEDICAL PATIENT CABLE SYSTEM (K980806)Affinity Medical Technologies, LLC1998-03-25
NITRILE EXAM GLOVE, POWDER-FREE, BLUE (K980802)Tucker & Associates1998-03-25
BCI 3401 HANDHELD PULSE OXIMETER (K980714)Bci Intl., Inc.1998-03-25
AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0 (K980574)Alfa Biotech (Uk) , Ltd.1998-03-24
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM (K974906)Coltene/Whaledent, Inc.1998-03-24
3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 (K980089)Valley West, Inc.1998-03-24
BRANEMARK SYSTEM(R) EBON(TM) FIXTURE (K974828)Nobel Biocare Uas, Inc.1998-03-24
QUANTA LITE B2 GPI SCREEN (K980230)Inova Diagnostics, Inc.1998-03-24
IP-16 (K980301)Servizi Medico Estetici Italinai Srl.1998-03-24
ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) (K980090)Luther Medical Products, Inc.1998-03-24
ASTRA TECH IMPLANT DENTAL SYSTEM (K974737)Astra Tech, Inc.1998-03-24
METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K980218)Biocompatibles Eyewear, Inc.1998-03-23
ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) (K980533)Etymotic Research1998-03-23
HURRISEAL DENTIN DESENSITIZER (K973002)Cheng & Assoc., Inc.1998-03-23
TRIMAX RADIOGRAPHIC CASSETTE (K980722)Imation Corp.1998-03-23
MERCURY DENTAL (K973548)Aleaciones Dentales Zeyco, S.A. DE C.V.1998-03-23
THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM (K974679)Medcon , Ltd.1998-03-23
MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A) (K971910)Hewlett-Packard GmbH1998-03-23
VYGON NEO-SUMP (K974806)Vygon Corp.1998-03-23
SELECTCELLS(TM) MINI (K974819)Select Medical Systems, Inc.1998-03-23
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM (K980488)Storz Instrument Co.1998-03-23
SOLOBOND M (K980539)Voco GmbH1998-03-23
ROUND WINDOW E-CATH (K973740)Neuro-Biometrix, Inc.1998-03-23
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A (K974881)Biosite Incorporated1998-03-20
MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE (K980062)Davis & Geck, Inc.1998-03-20
ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE (K980119)Guidant Corp.1998-03-20
INFINITY AST REAGENT (PROCEDURE NO. 51) (K980666)Sigma Diagnostics, Inc.1998-03-20
MICRO-STRIP FOR AMPHETAMINE METABOLITES (K974611)Microdiagnostics, Inc.1998-03-20
BIONX DISTAL RADIUS SCREW (K974876)Bionx Implants, Inc.1998-03-20
RAPID DRUG SCREEN' 8 PANEL (K980872)American Bio Medica Corp.1998-03-20
STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (K974798)Environmental Test Systems, Inc.1998-03-20
CRE(TM) BALLOON DILATATION CATHETER (K974788)Boston Scientific Corp1998-03-20
TOWNLEY PEDICLE SCREW PLATING SYSTEM (K970599)Danek Medical, Inc.1998-03-20
ELMED ESU 120 M/M DIGITAL (K974793)Elmed, Inc.1998-03-19
A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR (K980824)A&D Engineering, Inc.1998-03-19
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