Atlas FDA

2007

1,116 FDA 510(k) clearances · PMA decision year

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◉ Watch 2007

RecordFirmDate
CONCERTO MODEL C154DWK (P010031/S063)Medtronic Cardiac Rhythm Disease Management2007-03-26
INFUSE BONE GRAFT (P000054/S008)Medtronic Sofamor Danek USA, Inc.2007-03-23
LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S068)Boston Scientific2007-03-23
PROGRAMMER SOFTWARE APPLICAION MODEL 2812, VERSION 2.1 (P960040/S084)Boston Scientific2007-03-23
PRECISE AND PRECISE RX NITINOL STENT SYSTEMS (P030047/S002)Cordis US Corporation2007-03-23
CONTAK RENEWAL 1/3/3HE CRT-D DEVICES (P010012/S036)Boston Scientific Corp2007-03-23
TENDRIL LEAD FAMILY (P960013/S027)ABBOTT MEDICAL2007-03-23
STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S005)Abbott Vascular Devices2007-03-23
STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S004)Abbott Vascular Devices2007-03-23
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM (P000040/S009)Axora Medical, Inc.2007-03-23
RIATA ST LEADS (P950022/S037)ABBOTT MEDICAL2007-03-23
ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S057)Boston Scientific2007-03-23
PROGRAMMER SOFTWARE APPLICATION MODEL 2812, VERSION 1.4 (P960040/S083)Boston Scientific2007-03-23
KODAK MAMMOGRAPHY CAD ENGINE (P030007/S003)Carestream Health, Inc.2007-03-23
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPPERED FUSION DEVICE (P000058/S019)Medtronic Sofamor Danek USA, Inc.2007-03-23
RIATA LEAD FAMILY (P950022/S035)ABBOTT MEDICAL2007-03-23
STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S010)Starr Surgical Co.2007-03-23
AMO SENSAR SOFT ACRYLIC MONOFOCAL INTRAOCULAR LENSES (IOLS) (P980040/S011)Johnson & Johnson Surgical Vision, Inc.2007-03-22
STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S008)Starr Surgical Co.2007-03-22
STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER 1-PC AND 3-PC INTRAOCULAR LENSES (P990013/S012)Starr Surgical Co.2007-03-22
STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S006)Starr Surgical Co.2007-03-22
STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S007)Starr Surgical Co.2007-03-21
AMO SOFT ACRYLIC MULTIFOCAL IOLS (P960028/S017)Johnson & Johnson Surgical Vision, Inc.2007-03-21
NAVISTAR RMT DS CATHETER (P010068/S009)Biosense Webster, Inc.2007-03-21
AMO SENSAR SOFT ACRYLIC MONOFOCAL INTRAOCULAR LENSES (IOLS) (P980040/S012)Johnson & Johnson Surgical Vision, Inc.2007-03-20
AMO TECNIS ACRYLIC LENS, MODEL ZA9003 (P990080/S020)Johnson & Johnson Surgical Vision, Inc.2007-03-20
AMO SOFT ACRYLIC MULTIFOCAL IOLS (P960028/S018)Johnson & Johnson Surgical Vision, Inc.2007-03-20
AMO TECNIS ACRYLIC LENS, MODEL ZA9003 (P990080/S019)Johnson & Johnson Surgical Vision, Inc.2007-03-20
MENTOR SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE BREAST IMPLANTS (P990075/S017)Mentor Worldwide, LLC2007-03-19
UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S031)Urologix, LLC2007-03-19
IBI THERAPY CARDIAC ABLATION SYSTEM (P040014/S006)Irvine Biomedical, Inc.2007-03-16
IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF (P060019)Irvine Biomedical, Inc.2007-03-16
THERAPY DUAL 8 ABLATION CATHETER & IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S008)Irvine Biomedical,Inc.(Ibi)2007-03-16
VICTORY AF DR PULSE GENERATOR MODEL 5382 (P880086/S123)ABBOTT MEDICAL2007-03-16
CONTAK RENEWAL 3 RF (P010012/S148)Boston Scientific Corp2007-03-16
ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S013)Anika Therapeutics, Inc.2007-03-15
MEDTRONIC ENTRUST 35J & VIRTUOSO ICDS (P980016/S094)Medtronic Cardiac Rhythm Disease Management2007-03-15
CONCERTO ICD (P010031/S062)Medtronic Cardiac Rhythm Disease Management2007-03-15
DEXCOM STS SYSTEM (P050012/S008)Dexcom, Inc.2007-03-15
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S048)Terumo Medical Corporation2007-03-15
ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS (P010054/S001)Roche Diagnostics Corp.2007-03-13
MBT TIBIAL TRAY (P830055/S098)Depuy, Inc.2007-03-13
ROCHE ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFORMATORY TEST AND PRECICONTROL HBSAG (P990012/S001)Roche Diagnostics Corp.2007-03-13
ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS (P010054/S003)Roche Diagnostics Corp.2007-03-13
LATITUDE* PATIENT MANAGEMENT SYSTEM MODELS 6481 AND 6482 (P910077/S072)Boston Scientific2007-03-09
PRECISION SPINAL CORD STIMULATION SYSTEM (P030017/S018)Boston Scientific Corp2007-03-09
INFUSE BONE GRAFT (P050053)Medtronic, Inc.2007-03-09
ISOFLEX LEAD FAMILY (P960030/S014)ABBOTT MEDICAL2007-03-08
GUARDIAN REAL-TIME AND PARADIGM REAL-TIME SYSTEMS (P980022/S015)Medtronic Minimed2007-03-08
RIATA FAMILY OF LEADS (P950022/S034)ABBOTT MEDICAL2007-03-08
DEXTRUS STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEADS MODELS 4135,4136 & 4137 (P950037/S048)Biotronik, Inc.2007-03-08
SUPARTZ (P980044/S006)Seikagaku Corp.2007-03-07
ANGIOSCUPLT SCORING BALLOON CATHETER (P050018/S001)Spectranetics Corp.2007-03-07
MEDTRONIC RESTORE FAMILY IMPLANTABLE NEUROSTIMULATORS (P840001/S095)Medtronic Neuromodulation2007-03-07
POSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S021)Boston Scientific Corp2007-03-06
EASYTRAK IS-1 AND EASYTRAK LV-1 LEADS (P010012/S139)Boston Scientific Corp2007-03-06
ARCHITECT ANTI-HCV (P050042/S002)Abbott Laboratories, Inc.2007-03-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S012)Ortho-Clinical Diagnostics, Inc.2007-03-05
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S019)Boston Scientific Corp2007-03-02
2490G/H/J CARELINK MONITOR, 2020A CARDIOSIGHT READER (P890003/S111)Medtronic, Inc.2007-03-02
VARIOUS INSYNC FAMILIES OF CRT-ICDS (P010031/S055)Medtronic Cardiac Rhythm Disease Management2007-03-02
KAPPA & ENPULSE FAMILIES OF PACEMAKERS (P980035/S065)Medtronic, Inc.2007-03-02
SELECTED FAMILIES OF ICDS (P980016/S088)Medtronic Cardiac Rhythm Disease Management2007-03-02
GEM FAMILY OF ICDS (P900061/S068)Medtronic Cardiac Rhythm Disease Management2007-03-02
MAVERICK MONORAIL PTCA CATHETER SYSTEM (P860019/S219)Scimed Life Systems, Inc.2007-03-02
AMPLATZER DUCT OCCLUDER (P020024/S013)ABBOTT MEDICAL2007-03-01
AMPLATZER SEPTAL OCCLUDER (P000039/S018)ABBOTT MEDICAL2007-03-01
FINELINE II & THINLINE II (P960004/S038)Boston Scientific2007-02-28
COBAS AMPLICOR HEPTATIS C VIRUS (HCV) TEST (P000012/S012)Roche Molecular Systems, Inc.2007-02-28
EXABLATE 2000 (P040003/S002)Insightec, Ltd.2007-02-27
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S055)Advanced Bionics2007-02-26
DEXCOM STS SYSTEM (P050012/S007)Dexcom, Inc.2007-02-26
MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S025)Medtronic Vascular2007-02-23
CUTTING BALLOON ULTRA2 MONORAIL (P950020/S025)Boston Scientific Corp2007-02-23
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S002)Smith & Nephew, Inc.2007-02-23
MEDTRONIC ATTAIN OVER THE WIRE (OTW) LEFT VENTRICULAR LEAD (P010015/S026)Medtronic, Inc.2007-02-23
MULTI-LINK VISION CORONARY STENT SYSTEMS (P020047/S008)Abbott Vascular2007-02-16
VITALITY HE (P960040/S142)Boston Scientific2007-02-16
ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S005)LeMaitre Vascular, Inc.2007-02-16
BARD TEGRESS URETHRAL IMPLANT (P030030/S005)C.R. Bard, Inc.2007-02-16
MULTI-LINK VISION CORONARY STENT SYSTEMS (P970020/S048)Abbott Vascular, Inc.2007-02-16
CONTAK RENEWAL 3 (P010012/S147)Boston Scientific Corp2007-02-16
HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE (P050013)Tissue Seal, LLC2007-02-16
CONTAK RENEWAL TR (P030005/S041)Guidant Corp.2007-02-16
ANEURX AAADAVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S024)Medtronic Vascular2007-02-15
NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S004)Medinol, Ltd.2007-02-15
BIOTRONIK PACING AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P950037/S044)Biotronik, Inc.2007-02-15
NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S005)Medinol, Ltd.2007-02-15
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S017)Boston Scientific Corp2007-02-15
CONCERTO MODEL C154DWK IMPLANTABLE DEVICES (P010031/S058)Medtronic Cardiac Rhythm Disease Management2007-02-15
VITALITY & VITALITY AVT FAMILY (P960040/S140)Boston Scientific2007-02-15
BIOTRONIK PACING AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980023/S022)Biotronik, Inc.2007-02-15
THE RIATA ST FAMILY OF LEADS (P950022/S033)ABBOTT MEDICAL2007-02-15
KAINOX A+ ICD LEAD (P000009/S018)Biotronik, Inc.2007-02-15
VIRTUOSO MODELS D154AWG/D154VWC (P980016/S090)Medtronic Cardiac Rhythm Disease Management2007-02-15
LUMAX CRT DEVICE & CARDIOMESSENGER II (P050023/S003)Biotronik, Inc.2007-02-13
PHILOS DR-T AND CYLOS DR-T (P950037/S050)Biotronik, Inc.2007-02-13
SUPARTZ (P980044/S005)Seikagaku Corp.2007-02-13
CARPENTIER-EDWARDS PERIMOUNT MAGNA BIOPROSTHESES MODELS 3000 AND 3000TFX (P860057/S041)Edwards Lifesciences, LLC2007-02-13
EXPRESS2 CORONARY STENT SYSTEM (P020009/S033)Boston Scientific Scimed, Inc.2007-02-12
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Every clearance here is in the API, with alerts when new ones post.