Atlas FDA

2003

640 FDA 510(k) clearances · PMA decision year

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◉ Watch 2003

RecordFirmDate
MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL STIMULATON DESKTOP SOFTWARE (P970004/S023)Medtronic Neuromodulation2003-01-23
APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A) (P880086/S091)ABBOTT MEDICAL2003-01-22
PASSIVE PLUS DX, MODELS 1336T, 1342T, 1343K, 1345K, 1346T (P960030/S009)ABBOTT MEDICAL2003-01-22
APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A) (P830045/S083)St. Jude Medical, Inc.2003-01-22
EASYTRAK LEAD MODELS 4510, 4511, 4512 AND 4513 CORONARY VENOUS STEROID ELUTING SINGLE-ELECTRODE PACE/SENSE LEADS (P010012/S003)Boston Scientific Corp2003-01-22
APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A) (P900070/S028)St. Jude Medical, Cardiac Rhythm Management Divisi2003-01-22
TENDRIL DX, MODELS 1388 T/K & TENDRIL SDX MODELS 1488 T/K (P960013/S012)ABBOTT MEDICAL2003-01-22
RIATA SERIES DEFIBRILLATION LEAD SYSTEM (P950022/S015)ABBOTT MEDICAL2003-01-22
AV PLUS DX, MODEL 1368 (P880086/S090)ABBOTT MEDICAL2003-01-22
APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A) (P910023/S063)ABBOTT MEDICAL2003-01-22
EXPRESS AND EXPRESS2 CORONARY STENT SYSTEMS (P020009/S004)Boston Scientific Scimed, Inc.2003-01-22
GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S013)Guidant Corp.2003-01-21
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S014)Boston Scientific Scimed, Inc.2003-01-17
WALLSTENT (TIPS,ILAC,VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S005)Boston Scientific Corporation2003-01-17
ABBOTT HBE (RDNA) EIA (P790025/S008)Abbott Laboratories2003-01-17
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S016)Boston Scientific Corp2003-01-17
GALILEO/GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S015)Guidant Corp.2003-01-17
CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS (P010041/S001)Edwards Lifesciences, LLC2003-01-17
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S004)Hologic, Inc.2003-01-16
AMPLATZER SEPTAL OCCLUDER AND AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS (P000039/S003)ABBOTT MEDICAL2003-01-15
MENTOR TITAN INFLATABLE PENILE PROSTHESIS (P000006/S002)Coloplast Corp.2003-01-14
TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM (P980052/S002)Stryker Leibinger, GmbH & Co KG2003-01-14
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S006)Boston Scientific Corp2003-01-14
NOVACOR N100PC LVAS WITH OPTIONAL EPTFE INFLOW CONDUIT (P980012/S003)Worldheart, Inc.2003-01-10
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S015)Boston Scientific Corp2003-01-10
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S013)Boston Scientific Scimed, Inc.2003-01-10
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S004)Boston Scientific Corporation2003-01-10
BIOTRON PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (P970054/S001)Diasorin2003-01-09
BLU-U (P990019/S002)Sun Pharmaceutical Industries, Inc.2003-01-09
ACCESS HYBRITECH FREE PSA ON THE SYNCHRON LXI 725 SYSTEM (P970038/S006)Beckman Coulter, Inc.2003-01-09
BIOTRON PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S001)Diasorin2003-01-09
ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM (P850048/S018)Beckman Coulter, Inc.2003-01-09
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER (N18033/S038)Vistakon, Johnson & Johnson Vision Products, Inc.2003-01-08
BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S005)Medtimo, Inc.2003-01-08
MEDTRONIC ENHANCER ABLATION CATHETERS (P930029/S019)Medtronic, Inc.2003-01-08
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S006)Covidien, LLC2003-01-07
NOVOSTE BETA-CATH SYSTEM (P000018/S025)Best Vascular, Inc.2003-01-06
MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) PRODUCT (P900061/S054)Medtronic Cardiac Rhythm Disease Management2003-01-06
SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING (P020028)Philips Medical Systems, Inc.2003-01-03
ANCURE ENDOGRAFT SYSTEM (P990017/S037)Boston Scientific Corp2003-01-02
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Every clearance here is in the API, with alerts when new ones post.