Atlas FDA

2000

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

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RecordFirmDate
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 (K001081)Cardiodynamics International Corp.2000-06-30
RECTOSIGHT RS 300-04 (K994130)Sightline Technologies , Ltd.2000-06-30
FUTURA SAFETY SYRINGE (K000860)Sheila W. Pickering2000-06-30
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A (K001776)Agilent Technologies, Inc.2000-06-30
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER (K001688)Datex-Ohmeda, Inc.2000-06-30
MODEL 4000 EEG MONITOR WITH PSI (PSA4000) (K001069)Physiometrix, Inc.2000-06-30
QUART ARTERIAL FILTER, MODEL HBF 140 (K001787)Jostra Medizintechnik AG2000-06-30
ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT (K001227)Opti-Centre Laboratories2000-06-29
CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER (K992757)Cynosure, Inc.2000-06-29
LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM (K993154)A.R.C. Laser Corp.2000-06-29
STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF (K001705)Chester Labs, Inc.2000-06-29
ONTRAK TESTCUP 502, MODEL 3016641 (K001417)Roche Diagnostics Corp.2000-06-29
SUGAR CHEX ONE (K001443)Streck Laboratories, Inc.2000-06-29
SPINE SYSTEM EVOLUTION (K001080)Aesculap, Inc.2000-06-29
ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE (K001150)Novasys Medical, Inc.2000-06-29
URANUS, COMFORTOUCH LASER SYSTEM (K001031)Laser Max Medical Technologies Corp.2000-06-29
NICOLET EME LEGEND TC22 (K993939)Nicolet Biomedical2000-06-29
BD DIRECTIGEN FLU A+B (K001364)Bd Becton Dickinson Vacutainer Systems Preanalytic2000-06-28
ELECSYS INSULIN CALCHECK (K001846)Roche Diagnostics Corp.2000-06-28
XPLAN 2.1 (K001700)Radionics, Inc.2000-06-28
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 (K001679)Ortho-Clinical Diagnostics, Inc.2000-06-28
FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM (K994419)Qualisys Diagnostics, Inc.2000-06-28
MODIFIED SINGLE AXLE TOTAL ELBOW (K000683)Biomet, Inc.2000-06-27
ELECTROSURGICAL ELECTRODE FAMILY (K001151)Novasys Medical, Inc.2000-06-27
MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM (K001305)General Electric Medical Systems Information Techn2000-06-27
MONARCH II IOL DELIVERY SYSTEM (K001157)Alcon Research, Ltd.2000-06-27
AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR (K001382)Aaron Medical Industries2000-06-27
MODIFICATION TO NC-STAT (K000565)Neurometrix, Inc.2000-06-27
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM (K001258)Cordis Corp.2000-06-27
SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES (K001517)Shimadzu Corp.2000-06-27
SCANDINAVIAN IVF SCIENCES AB, G2.2 (K000619)Vitrolife AB/Scandinavian Ivf Sciences AB2000-06-27
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 (K001180)Pace Medical2000-06-27
LEICA COLPOSCOPE (K000707)Leica Microscopy Systems , Ltd.2000-06-27
ADVIA IMS (K001344)Bayer Corp.2000-06-26
MACROPOREDX DISTRACTOR SYSTEM (K000992)Macropore Biosurgery, Inc.2000-06-26
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM (K001226)Smith & Nephew, Inc.2000-06-26
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) (K001569)Sigma Diagnostics, Inc.2000-06-26
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES (K001672)Pamitex Industries Sdn Bhd2000-06-23
TRIFLANGE ACETABULAR CUP SYSTEM (K001277)DePuy Orthopaedics, Inc.2000-06-23
UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED (K000827)Walter Abendschein, M.D.2000-06-23
LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K001274)Pt. Maja Agung Latexindo2000-06-23
NYLON, NONABSORBABLE SURGICAL SUTURES USP (K001173)Cp Medical2000-06-23
PALCERAM 49 (K001481)Aurex SA (Pty) , Ltd.2000-06-23
GALILEO VENTILATOR (K001686)Hamilton Medical, Inc.2000-06-23
ACULUX, MODEL AX3001, AX3002 (K001223)Aculux2000-06-23
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP (K001185)Cp Medical2000-06-23
VIVANT MEDICAL BIOPSY MARKER SYSTEM (K000278)Vivant Medical, Inc.2000-06-23
OPUS 10 DENTAL DIODE LASER (K000990)Opusdent , Ltd.2000-06-23
AUDIO TECHNOLOGIES S:R.1 (K001142)Audio Technologies S.R.L.2000-06-23
HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE (K000351)Hanwella Rubber Products , Ltd.2000-06-23
FIRST CHECK HOME DRUG TEST PANEL 2 (K994139)Worldwide Medical Corp.2000-06-23
SULZER ORTHOPEDICS MS-30 FEMORAL STEM (K001078)Sulzer Orthopedics, Inc.2000-06-23
STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 (K001649)Steritec Products, Inc.2000-06-23
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) (K001107)Fresenius Medical Care North America2000-06-23
VARIS 1.4G (K001643)Varian Medical Systems, Inc.2000-06-23
BIOSOFT RESIN (K001640)Biosoft International Corp.2000-06-23
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR (K001637)Sheen More Ent. Co., Ltd.2000-06-23
KLINIDRAPE SURGICAL DRAPES (K000906)Molnlycke Health Care, Inc.2000-06-23
GEMINI E (K993623)Allen Medical Instruments Corp.2000-06-23
SILK, NONABSORBABLE, SURGICAL SUTURES, USP (K001184)Cp Medical2000-06-23
AURENORM 75 KF (K001482)Aurex SA (Pty) , Ltd.2000-06-23
IL TEST LIQUID ANTITHROMBIN (K994238)Instrumentation Laboratory CO2000-06-23
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP (K001299)Cp Medical2000-06-23
DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES (K001601)Shanghai PT Plastics Enterprise Company, Ltd.2000-06-23
POLYESTER NONABSORBABLE SURGICAL SUTURES URP (K001172)Cp Medical2000-06-23
FIRST CHECK HOME DRUG TEST (THC) (K993663)Worldwide Medical Corp.2000-06-23
RESOLVE SURGICAL O.R. TOWELS (K001667)Allegiance Healthcare Corp.2000-06-23
FIRST CHECK HOME DRUG TEST PANEL 3 (K994138)Worldwide Medical Corp.2000-06-23
VASO PRESS DVT SYSTEM, MODELS VP500, VP501 (K991038)Britt Corp., Inc.2000-06-22
ANATOMIC TOTAL KNEE PROSTHESIS (K000978)Biomet, Inc.2000-06-22
CRITERION 60 OR PM 60 (K000959)Caradyne, Ltd.2000-06-22
ORTHOCEPH OC100 D (K001439)Instrumentarium Corp.2000-06-22
CD HORIZON ECLIPSE (K001066)Medtronic Sofamor Danek, Inc.2000-06-22
BIPAP DUET LX BI-LEVEL SYSTEM (K000994)Respironics, Inc.2000-06-22
DBEST HCG 2 IU/ML TEST KIT (K001215)Ameritek, Inc.2000-06-22
AEQUALIS UNIVERSAL SHOULDER GLENOID (K994393)Tornier2000-06-22
NOVAC7 (K990209)Hitesys S.P.A.2000-06-22
CLICKER (K994384)Bioject, Inc.2000-06-22
ULTRASIM CT SYSTEM (K001088)Philips Medical Systems (Cleveland), Inc.2000-06-22
MILLENNIA ACUPUNCTURE NEEDLE (K001718)United Pacific Co., Ltd.2000-06-21
INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST (K994410)Alfa Scientific Designs, Inc.2000-06-21
AURECAST 40 B (K001480)Aurex SA (Pty) , Ltd.2000-06-21
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM (K001629)Disetronic Medical Systems AG2000-06-21
MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM (K001219)Biomedical Ent., Inc.2000-06-21
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT (K001769)Ortho-Clinical Diagnostics2000-06-21
SERAGARD INJECTION PATCH (K001240)Platinum Services, Inc.2000-06-21
TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG (K001786)Sulzer Calcitek, Inc.2000-06-21
BEHRING COAGULATION TIMER ANALYZER (BCT) (K001064)Dade Behring, Inc.2000-06-21
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 (K992606)Canon USA, Inc.2000-06-21
PALCERAM 53 (K001479)Aurex SA (Pty) , Ltd.2000-06-21
DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC (K001269)Dentalmatic Technologies, Inc.2000-06-21
AURELUX Y 84 PREMIUM (K001477)Aurex SA (Pty) , Ltd.2000-06-20
3D-MSPECT (K001026)The Reagents of the University of Michigan2000-06-20
MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL (K001312)Igc-Medical Advances, Inc.2000-06-20
INSUFFLATION NEEDLE- 120MM, MODEL 900-200 (K993625)Genicon, LC2000-06-20
MEDI-CULT M3 MEDIUM (K991331)Medicult A/S2000-06-20
AURECAST SUPER INLAY (K001478)Aurex SA (Pty) , Ltd.2000-06-20
M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1 (K001711)Agilent Technologies, Inc.2000-06-20
SYNTHES (USA) ORIBITAL MESH PLATES (K001311)Synthes (Usa)2000-06-20
MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY (K993176)Norland Medical Systems, Inc.2000-06-20
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