Atlas FDA

1999

3,554 FDA 510(k) clearances · Clearance year

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RecordFirmDate
THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K992166)Zeus Scientific, Inc.1999-09-03
PACIFIC HEMOSTASIS THROMBOSCREEN 400C (K992130)Pacific Hemostasis1999-09-03
LORAD 1-650 (INTERNATIONAL 650) (K992280)Lorad Corp.1999-09-03
UROLOGICAL CATHETER (K992137)Apogee, Inc.1999-09-03
SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321 (K991979)Medtronic Minimed1999-09-03
ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 (K990689)Zcv ,Inc.1999-09-03
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM (K991185)Zeus Scientific, Inc.1999-09-03
LIFEPAK 12 BIPHASIC (K991910)Physio-Control Corp.1999-09-03
O2N DEMAND-II, VICTOR MODEL OCPR-II (K992659)Thermadyne Holings Corp.1999-09-03
QCT BONE MINERAL ANALYSIS SOFTWARE (K992246)Image Analysis, Inc.1999-09-03
BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE (K992088)Genzyme Surgical Product (Genzyme Biosurgery)1999-09-03
BACT/ALERT PF (K992401)Organon Teknika Corp.1999-09-03
GRAND CERAM (K992023)Noritake Co., Inc.1999-09-03
BACTALERT FA (K992400)Organon Teknika Corp.1999-09-03
FLEXIBLADE (K984101)Arco Medic , Ltd.1999-09-03
IS H. PYLORI IGG ELISA TEST SYSTEM (K990462)Columbia Bioscience, Inc.1999-09-03
MODIFICATION OF NOGA (K990494)Biosense, Inc.1999-09-03
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM (K991180)Zeus Scientific, Inc.1999-09-03
SOOTHE-N-SEAL CANKER SORE RELIEF (K991923)Closure Medical Corp.1999-09-02
ASTOTHERM PLUS, ASTOTUBES, ASTOLINE (K991160)Stihler Electronic GmbH1999-09-02
MAGNESIUM PRODUCT NO'S, 112-01, 112-02 (K991761)A.P. Total Care, Inc.1999-09-02
DRUGCHECK X MULTIDRUG SCREENING DEVICE (K992748)Syntron Bioresearch, Inc.1999-09-02
SAGE CONTRAST MANAGEMENT SYSTEM (K991112)Sage Laboratories, Inc.1999-09-02
RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 (K990867)Advanced Cardiovascular Systems, Inc.1999-09-02
LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 (K992172)Bio-Rad1999-09-02
DR. B'S MOUTHPIECE, MODEL 32129-10002 (K991948)Snore - Ezzer1999-09-02
ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 (K991762)A.P. Total Care, Inc.1999-09-02
VANTAGE EXSPECT II (K992078)Adac Laboratories1999-09-01
NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM (K990338)Physio-Control Corp.1999-09-01
C-QUEST (K992103)Wuestec Medical, Inc.1999-09-01
A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE (K992808)A&D Medical Div.1999-09-01
DIGITAL IMAGING SYSTEM (BSR) (K991922)Siemens Medical Solutions USA, Inc.1999-09-01
SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM (K992761)Medison America, Inc.1999-09-01
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE (K992570)Howmedica Osteonics Corp.1999-09-01
CERALAS D10 810NM DIODE LASER (K992773)Ceram Optec, Inc.1999-09-01
CORE POUCH (K992190)Core Dynamics, Inc.1999-09-01
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES (K991899)Nihon Kohden America, Inc.1999-09-01
CUFF-ABLE PLUS (K990412)Vital Signs, Inc.1999-09-01
PATTON SPECULUM (K991963)Patton Medical Corp.1999-09-01
COROMETRICS MODEL 171 AND 172 FETAL MONITOR (K991905)General Electric Medical Systems Information Techn1999-09-01
ENDIUS SUCTION/IRRIGATION INSTRUMENT (K992535)Endius, Inc.1999-09-01
TM-300 TRACTION SYSTEM (K992545)Ito Co., Ltd.1999-09-01
PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE (K974387)Microwave Medical Systems, Inc.1999-09-01
INTRASTENT II (K990592)Intratherapeutics, Inc.1999-09-01
DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE (K990873)Ameritek, Inc.1999-09-01
REUNITE SCREWS (K992301)Biomet Manufacturing, Inc.1999-09-01
OPTIMAX/ COMPACT 2 (K992818)Protec GmbH & Co. KG1999-09-01
HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A (K992636)Hewlett-Packard Co.1999-08-31
LUMA LIGHT 2000 CURE LIGHT (K992102)Lumalite, Inc.1999-08-31
MODIFICATION OF JMS NEEDLES AND JMS SYRINGES (K991904)Jms Co., Ltd.1999-08-31
LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN) (K991777)Seltom Pacific Sdn. Bhd.1999-08-31
EQUINOX OCCLUSION BALLOON SYSTEM (K990487)Micro Therapeutics, Inc.1999-08-31
O.B. TAMPON (K990536)Personal Products Co.1999-08-31
LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE) (K991778)Seltom Pacific Sdn. Bhd.1999-08-31
MEDTRONIC AVE BRIDGE STENT (K992569)Medtronic Ave, Inc.1999-08-31
CARD GUARD, MODEL CG-6550 (K990478)Card Guard Scientific Survival , Ltd.1999-08-31
PASCO MIC AND MIC/ID PANELS (CEFUROXIME) (K992076)Pasco Laboratories, Inc.1999-08-30
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT (K992241)Hemagen Diagnostics, Inc.1999-08-30
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM (K992162)Safeskin Corp.1999-08-30
MEDIFIX INC. (K992483)Medifix, Inc.1999-08-30
PASCO MIC AND MIC/ID PANELS (K992059)Pasco Laboratories, Inc.1999-08-30
JMS APHERESIS NEEDLE (K990510)Jms Co., Ltd.1999-08-30
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT (K992224)Hemagen Diagnostics, Inc.1999-08-30
ENDOSONICS TRAK BACK DEVICE (K990271)Endosonics Corp.1999-08-30
TOF-WATCH S (K992596)Organon Teknika Corp.1999-08-30
REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM (K992066)GE Medical Systems1999-08-30
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL (K991237)Radionics, Inc.1999-08-30
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT (K992243)Hemagen Diagnostics, Inc.1999-08-30
TELEMEDICINE 2000 (K992164)Card Guard Scientific Survival , Ltd.1999-08-30
EASY-CURE (CURING AND WHITENING LIGHT) (K992357)Ics of North America, Inc.1999-08-30
TOF-WATCH SX (K992598)Organon Teknika Corp.1999-08-30
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992463)Shijiazhuang Dilly Plastics Products Co., Ltd.1999-08-30
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (K992430)Medical Analysis Systems, Inc.1999-08-30
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 (K991437)Wells Johnson Co.1999-08-30
JMS A. V. FISTULA NEEDLE SET (K990470)Jms Co., Ltd.1999-08-30
RENACLEAR DIALYZER CLEANING SYSTEM (K991851)Minntech Corp.1999-08-30
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE (K992223)Pamitex Industries Sdn Bhd1999-08-30
CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) (K990310)Charter Medical, Ltd.1999-08-30
SEDATELEC ASP ACUPUNCTURE NEEDLES (K983798)Sedatelec1999-08-27
DYRACT SEAL COMPOMER PIT & FISSURE SEALANT (K992516)Dentsply Intl.1999-08-27
CERSR ELECTROMYOGRAPHY SYSTEM (K990766)Paraspinal Diagnostic Corp.1999-08-27
DYNA-LOK PLUS SPINAL SYSTEM (K991198)Sofamor Danek USA,Inc.1999-08-27
ANATOMICAL BANKART TACK, MODEL 523520A (K992567)Bionx Implants, Ltd.1999-08-27
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI (K991726)Binax, Inc.1999-08-27
ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (K992283)Airsep Corp.1999-08-27
FERRIS POLYOSTOMY STERILE WOUND DRESSING (K991729)Ferris Mfg. Corp.1999-08-27
NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX (K992304)Image-Guided Neurologics, Inc.1999-08-27
REPOSE BONE SCREW SYSTEM (K981677)Influence, Inc.1999-08-27
LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) (K990903)Laserscope1999-08-27
ACUMASTER BRAND ACUPUNCTURE NEEDLE (K991508)Helio Medical Supplies, Inc.1999-08-27
MONOPOLAR ELECTRODES AND CABLES (K992485)Us Endo, Inc.1999-08-27
PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) (K990261)Plus Orthopedics1999-08-27
TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS (K990785)Jakoubek Medizintechnik GmbH1999-08-27
TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE (K992071)Ron-Tech Medical , Ltd.1999-08-27
BELLEGLAZE (K992067)Kerr Dental Materials Center1999-08-27
MITAKA POINT SETTER (K991989)Mitaka USA, Inc.1999-08-27
KANGNIAN BRAND ACUPUNCTURE NEEDLE (K991507)Helio Medical Supplies, Inc.1999-08-27
SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION (K992457)Surgical Navigation Specialists, Inc.1999-08-27
SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS (K991995)Softchrome, Inc.1999-08-27
SUPER PORCELAIN TI-22 (K992024)Noritake Co., Inc.1999-08-27
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