Atlas FDA

2000

3,453 FDA 510(k) clearances · Clearance year

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RecordFirmDate
AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI (K001333)Agilent Technologies Deutschland GmbH2000-05-17
NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) (K000812)Neurosoft, Inc.2000-05-17
ST/AR ST AND ARRHYTHMIA SOFTWARE (K001348)Agilent Technologies, Inc.2000-05-17
AMBU NEONATE SILICONE RESUSCITATOR (K993278)Ambu, Inc.2000-05-17
HEART 2005 (K000775)Aerotel Medical Systems (1998) , Ltd.2000-05-17
CIDEX OPA SOLUTION (K001381)Advanced Sterilization Products2000-05-17
ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS (K000556)Elan Diagnostics2000-05-17
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB (K000121)Beckman Coulter, Inc.2000-05-17
MODIFICATION TO ENVOY PATIENT MONITOR (K000563)Mennen Medical , Ltd.2000-05-17
IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500 (K991348)Vitrolife Sweden AB2000-05-17
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. (K001225)Princeton BioMeditech Corp.2000-05-17
VITA RESPONSE (K000597)Vident2000-05-17
INTERCURE LTD. RESPI-LOW (K000405)Intercure , Ltd.2000-05-17
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100 (K001224)Guidant Corp.2000-05-17
ARACHNOPHLEBECTOMY NEEDLE (K000932)Advanced Medical Products, Inc.2000-05-17
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) (K001431)Radionics, Inc.2000-05-17
MRI FASTSYSTEM RETRACTOR SYSTEM (K001339)Omni-Tract Surgical, Div. Minn. Scientific, Inc.2000-05-17
ALLROUND 55 LF (K001260)J.F. Jelenko & Co., Inc.2000-05-17
BELMONT UNIT, MODEL 2000 SERIES (K000799)Belmont Equipment Corp.2000-05-17
3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE (K000690)Minnesota Mining and Mfg. Co.2000-05-17
AXIOM MULTIPURPOSE WOUND DRAIN (K993592)Axiom Medical, Inc.2000-05-17
SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1 (K000618)Vitrolife AB/Scandinavian Ivf Sciences AB2000-05-17
OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1 (K001222)Guidant Corp.2000-05-17
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM (K000155)Roche Diagnostics Corp.2000-05-17
ULTRA CATHETER SET (K001115)Lyco Enterprises, Inc.2000-05-17
BELLEGLASS HP ENAMEL (K000530)Sybron Dental Specialties, Inc.2000-05-17
ALL-PRO 2010 (K001321)All-Pro Imaging Corp.2000-05-16
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB (K000303)Healthcare Service and Supply2000-05-16
C-IT (K000520)Bregas AB2000-05-16
ENDOPATH SURESEAL REDUCER CAP (K001220)Ethicon Endo-Surgery, Inc.2000-05-16
PROVIEW MEDICAL IMAGE DISPLAY MODULE (K000770)Cerner Corp.2000-05-16
THE STRIPPER (K993699)Mid-Atlantic Diagnostics, Inc.2000-05-16
SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1 (K000623)Vitrolife AB/Scandinavian Ivf Sciences AB2000-05-16
SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR (K001438)Somnus Medical Technologies, Inc.2000-05-16
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (K001013)Airsep Corp.2000-05-16
SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100 (K000621)Vitrolife AB/Scandinavian Ivf Sciences AB2000-05-16
APOLLO MULTI-RACIAL REFERENCE POPULATION (K993337)Norland Medical Systems, Inc.2000-05-16
OPTIVU HDVD SYSTEM (K001169)Optimize, Inc.2000-05-16
UMECO OPTIMA MULTILINE LASER SYSTEM (K000693)Medical Laser Solutions, LLC2000-05-16
ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX (K994334)Daig Corp.2000-05-15
MEDART 520 COOLING SYSTEM (K000503)Medart Corp.2000-05-15
ART-M1, MODEL M1-1-ART-A1 (K000510)Bonart Co., Ltd.2000-05-15
ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K001239)Ansell Perry2000-05-15
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 (K000399)OraSure Technologies, Inc.2000-05-15
SOLO-CARE BRAND HARD SOLUTION (K000607)Ciba Vision Corporation2000-05-15
BVBLUE (K993732)Gryphus Diagnostics, LLC2000-05-15
JETLITE 4000 (K000078)J. Morita USA, Inc.2000-05-15
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS (K001232)Fitco Dipped Products Pvt., Ltd.2000-05-15
STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 (K001444)Steritec Products, Inc.2000-05-15
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS (K993760)Hartalega Sdn Bhd2000-05-15
QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K000928)Oxoid , Ltd.2000-05-15
NUZONE NITRILE SURGICAL GLOVES POWDER FREE (K000179)Terang Nusa Sdn Bhd2000-05-15
STRYKER IRRIGATION TUBE SET (K000493)Stryker Endoscopy2000-05-15
COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES (K001280)Wrp Asia Pacific Sdn. Bhd.2000-05-15
EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER (K000926)Medica Corp.2000-05-15
HYDRO2, HS-75 (K000485)Innovision, Inc.2000-05-12
METRISCAN BONE DENSITY SYSTEM (K000162)Alara, Inc.2000-05-12
SPIROVIT SP-2, PNEUMOCHECK II (K992823)Schiller AG2000-05-12
WALLSTENT ENTERNAL PROSTHESIS (K000281)Boston Scientific Corp2000-05-12
URETHROTOME 8667.XXX AND 8670.XXX (K000905)Richard Wolf Medical Instruments Corp.2000-05-12
AIRPILOTMASK, MODEL TMS-900 (K992192)Tiara Medical Systems, Inc.2000-05-12
EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 (K000950)Labotect Labor-Technik Gottingen2000-05-12
PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER (K001368)Carmel Pharma Ab.2000-05-12
GE SYSTEM FIVE (K001267)Ge Medical Systems, Inc.2000-05-12
ESPIRT (K001208)Respironics, Inc.2000-05-12
DELTA 16 TACT (K001171)Instrumentarium Imaging, Inc.2000-05-12
BALLOON FOR ULTRASONIC ENDOSCOPES (K992178)N.M. Beale Co., Inc.2000-05-12
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET (K001198)Datascope Corp.2000-05-12
PHILIPS CT SECURA MV (K000819)Philips Medical Systems North America, Inc.2000-05-12
OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 (K000948)Keymed (Medical & Industrial Equipment), Ltd.2000-05-12
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 (K000915)Humagen Fertility Diagnostics, Inc.2000-05-12
MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM (K000630)Hopkins Imaging Systems, Inc.2000-05-12
RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S (K001030)Dymedix, Inc.2000-05-11
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR (K991886)Pulsion Medical Systems, Inc.2000-05-11
JEL BIOS 90 (CODE NAME RD-2401) (K001196)J.F. Jelenko & Co., Inc.2000-05-11
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR (K000706)Datex-Ohmeda, Inc.2000-05-11
WAND PLUS (K992819)Spintech, Inc.2000-05-11
MD 10, SEM, SM 12, CBM (K000710)NOUVAG AG2000-05-11
LATERAL PIVOT INSERT (K000590)Encore Orthopedics, Inc.2000-05-11
MODEL 4300 PSARRAY EEG ELECTRODE SET (K001055)Physiometrix, Inc.2000-05-11
ERS RADIAL HEAD REPLACEMENT (K000658)DePuy Orthopaedics, Inc.2000-05-11
XIA SPINE SYSTEM (K001272)Howmedica Osteonics Corp.2000-05-11
UNI-LASER 430 (K993815)Medart Corp.2000-05-11
HEADLAMP HL2000. (K994362)Angiolaz, Inc.2000-05-11
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 (K001145)Dade Behring, Inc.2000-05-11
PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) (K000694)Pectofix, Inc.2000-05-11
STRYKER TRAUMA PLATING SYSTEM (K000636)Howmedica Osteonics Corp.2000-05-11
PQ1 (K000189)Ultradent Products, Inc.2000-05-11
MULTI-AXIAL CROSS (MAC) CONNECTOR (K000965)Howmedica Osteonics Corp.2000-05-11
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA (K001197)OraSure Technologies, Inc.2000-05-11
COLORADO II SPINAL SYSTEM (K991031)Sofamor Danek USA,Inc.2000-05-10
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M (K001139)Biosense Webster, Inc.2000-05-10
KEYSTONE HIP (K000521)Encore Orthopedics, Inc.2000-05-10
RUMBAR DRAINAGE SYSTEM (K000514)Phoenix Biomedical Corp.2000-05-10
POSI-LINK (K000472)Icu Medical, Inc.2000-05-10
RHIGENE MESACUP2 TEST- SSA (K000749)Rhigene, Inc.2000-05-09
RHIGENE MESACUP2 TEST- SM (K000755)Rhigene, Inc.2000-05-09
TROJAN EXTRA LARGE LATEX CONDOM (K001212)Armkel, LLC2000-05-09
FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 (K000451)Fresenius Medical Care North America2000-05-09
MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015) (K991471)Medicult A/S2000-05-09
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