Atlas FDA

2009

1,492 FDA 510(k) clearances · PMA decision year

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◉ Watch 2009

RecordFirmDate
EASYTRAK 2 LEADS (P010012/S206)Boston Scientific Corp2009-04-16
CONCERTO CRT-D (P010031/S135)Medtronic Cardiac Rhythm Disease Management2009-04-16
VIRTUOSO ICD (P980016/S168)Medtronic Cardiac Rhythm Disease Management2009-04-16
CADENCE FAMILY OF ICDS (P910023/S204)ABBOTT MEDICAL2009-04-16
PULSE GENERATORS PHILOS II DR-T/CYLOS DR-T (P950037/S071)Biotronik, Inc.2009-04-16
PROMOTE/PROMOTE + CRT-D (P030054/S120)ABBOTT MEDICAL2009-04-16
X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM (P040001/S014)Medtronic Sofamor Danek, Inc.2009-04-16
SYNCHROMED II INFUSION PUMP (P860004/S106)Medtronic, Inc.2009-04-16
ST JUDE MEDICAL TENDRIL ST MODEL 1888 LEAD (P960013/S045)ABBOTT MEDICAL2009-04-16
FREEZOR CARDIAC CRYOABLATION CATHETERS/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES& CCT.2 CRYOCONSOLE SYSTE (P020045/S027)Medtronic Cryocath, LP2009-04-16
CARDIOMESSENGER II-S (TLINE) SOFTWARE VERSION 1.20, CARDIOMESSENGER LLT, CARDIOMESSENGER TLINE; CARDIOMESSENGER II (P050023/S023)Biotronik, Inc.2009-04-16
VIRTUOSO ICD/VIRTUOSO II ICD/SECURA ICD/MAXIMO II ICD (P980016/S188)Medtronic Cardiac Rhythm Disease Management2009-04-15
MYNX VASCULAR CLOSURE DEVICE (P040044/S012)Cordis US Corporation2009-04-15
FREQUENCY 55 UV (METHAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR (P850079/S045)CooperVision, Inc.2009-04-15
CONCERTO CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D (P010031/S151)Medtronic Cardiac Rhythm Disease Management2009-04-15
CADENCE FAMILY OF ICDS (P910023/S203)ABBOTT MEDICAL2009-04-14
EPIC HF / ATLAS + HF FAMILY OF CRT-DS (P030054/S119)ABBOTT MEDICAL2009-04-14
THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S004)Srs Medical2009-04-14
VERSANT HCV RNA 3.0 (BDNA) WITH VERSANT 440 MOLECULAR SYSTEM (P020022/S007)Siemens Healthcare Diagnostics, Inc.2009-04-14
EXPRESS 2 OTW (P020009/S048)Boston Scientific Scimed, Inc.2009-04-13
TAXUS EXPRESS 2 OTW (P030025/S060)Boston Scientific Corp2009-04-13
TAXUS LIBERTE OTW (P060008/S004)Boston Scientific Corp2009-04-13
LIBERTE OTW (P040016/S034)Boston Scientific Scimed, Inc.2009-04-13
MAVERICK OTW (OVER-THE-WIRE) AND QUANTUM MAVERICK OTW (P860019/S230)Scimed Life Systems, Inc.2009-04-13
MINILINK REAL-TIME TRANSMITTER & CGMS IPRO DIGITAL RECORDER (P980022/S050)Medtronic Minimed2009-04-13
AMPLATZER 45 DELIVERY & EXCHANGE SYSTEMS (P000039/S030)ABBOTT MEDICAL2009-04-13
AMPLATZER 180 DELIVERY & EXCHANGE SYSTEMS (P020024/S025)ABBOTT MEDICAL2009-04-13
CORONARY FLEXTOME CUTTING BALLOON DEVICE (P950020/S032)Boston Scientific Corp2009-04-13
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S011)Abbott Laboratories2009-04-13
ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS (P080023)Abbott Laboratories2009-04-10
SYNVISC (P940015/S013)Sanofi Genzyme Corp.2009-04-10
MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSORS ON PHILLIPS BASE MODELS MMT-7002, MMT-7003 (P980022/S048)Medtronic Minimed2009-04-09
ADVIA CENTAUR HBSAG READYPACK REAGENTS / CONFIRMATORY ASSAY/ QUALITY CONTROL MATERIAL (P030049/S004)Siemens Healthcare Diagnostics2009-04-09
FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM (P050020/S013)Abbott Laboratories2009-04-09
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/TOTAL QUALITY CONTROL MATERIALS (P040004/S004)Siemens Healthcare Diagnostics2009-04-09
ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS (P030056/S004)Siemens Healthcare Diagnostics2009-04-09
ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS & CONTROL MATERIAL (P030029/S005)Siemens Healthcare Diagnostics2009-04-09
ADVIA CENTAUR HBC IGM READYPACK REAGENTS/QUALITY CONTROL MATERIALS (P030040/S004)Siemens Healthcare Diagnostics2009-04-09
ACTICON ARTIFICAL BOWEL SPHINCTER (ABS) (P010020/S013)Boston Scientific Corp2009-04-08
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S014)Boston Scientific Corp2009-04-08
AMS 800 ARTIFICAL URINARY SPHINCTER (AUS) (P000053/S023)Boston Scientific Corp2009-04-08
M5 MYNX VASCULAR CLOSURE DEVICE (P040044/S011)Cordis US Corporation2009-04-08
AUTODELFIA HAFP KIT (P970037/S002)Revvity, Inc.2009-04-08
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S057)Terumo Medical Corporation2009-04-08
MOSAIC PORCINE BIOPROSTHESIS (P990064/S026)Medtronic, Inc.2009-04-08
AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S009)ABBOTT MEDICAL2009-04-08
HANCOCK II BIOPROSTHESIS (P980043/S018)Medtronic, Inc.2009-04-08
LIBERTE CORONARY STENT SYSTEM (P040016/S035)Boston Scientific Scimed, Inc.2009-04-08
QUANTUM MAVERICK PTCA /MAVERICK2 PTCA CATHETERS (P860019/S233)Scimed Life Systems, Inc.2009-04-08
RESTOREULTRA IMPLANTABLE NEUROSTIMULATOR (P840001/S133)Medtronic Neuromodulation2009-04-08
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S040)W. L. Gore & Associates, Inc.2009-04-08
RESTYLANE AND PERLANE INJECTABLE GEL (P040024/S037)Q-Med AB2009-04-08
EXPRESS2 CORONARY STENT SYSTEM (P020009/S049)Boston Scientific Scimed, Inc.2009-04-08
AMPLATZER DUCT OCCLUDER (P020024/S023)ABBOTT MEDICAL2009-04-08
SOF-SENSOR GLUCOSE SENSOR (P980022/S051)Medtronic Minimed2009-04-08
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S063)Boston Scientific Corp2009-04-08
CADENCE FAMILY OF ICDS (P910023/S201)ABBOTT MEDICAL2009-04-08
EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S117)ABBOTT MEDICAL2009-04-08
SEPTAL OCCLUDER AND MULTIFENESTRATED SEPTAL (CRIBRIFORM) OCCLUDER (P000039/S029)ABBOTT MEDICAL2009-04-08
ACTIVA PC IMPLANTABLE NEUROSTIMULATION SYSTEM (P960009/S052)Medtronic, Inc.2009-04-07
DRIVER CORONARY STENT SYSTEMS (P030009/S034)Medtronic, Ireland2009-04-07
GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S014)W. L. Gore & Associates, Inc.2009-04-07
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S034)Medtronic, Inc.2009-04-07
MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006)Medtronic, Inc.2009-04-07
RESTYLANE AND PERLANE INJECTABLE GEL (P040024/S036)Q-Med AB2009-04-06
VOYAGER RX CORONARY DILATATION CATHETER (P810046/S228)Advanced Cardiovascular Systems, Inc.2009-04-06
CGMS IPRO CONTINUOUS GLOCOSE MONITORING SYSTEM (P980022/S047)Medtronic Minimed2009-04-06
KAPPA 400 DR/SR IPGS (P970012/S054)Medtronic, Inc.2009-04-03
ENTRUST/VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR (P980016/S186)Medtronic Cardiac Rhythm Disease Management2009-04-03
CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II (P010031/S149)Medtronic Cardiac Rhythm Disease Management2009-04-03
ICS 3000/EDP 30/CARDIOMESSENGER (P950037/S070)Biotronik, Inc.2009-04-03
KAPPA 600/700/650/800/900 IPGS/ENPULSE/SIGMA/MEDTRONIC 350 SERIES/AT500/ENRHYTHM/ADAPTA/VERSA/SENSIA/RELIA IPGS (P980035/S132)Medtronic, Inc.2009-04-03
AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (P060022/S004)Bausch & Lomb, Inc.2009-04-03
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S075)Boston Scientific Corp2009-04-03
ENRHYTHM/ADAPTA/VERSA/SENSIA/RELIA (P980035/S133)Medtronic, Inc.2009-04-03
CARDIOMESSENGER TLINE/CARDIOMESSENGER II/CARDIOMESSENGER II-S (P050023/S022)Biotronik, Inc.2009-04-03
INSYNC CRT-P & INSYNC III CRT-P (P010015/S066)Medtronic, Inc.2009-04-03
DEMA FAMILY (INCLUDES CLARITY DDDR, CLARITY SSIR, DIAMOND III, RUBY III, TOPAZ III, JADE III, VITA DDDR AND VITA II) (P990001/S053)Medtronic, Inc.2009-04-03
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005)Cook Incorporated2009-04-02
OVATIO VR/DR (P980049/S046)MicroPort CRM USA, Inc.2009-04-02
STAAR SURGICAL COLLAMER UV-ABSORBING PC INTRAOCULAR LENS (P990013/S018)Starr Surgical Co.2009-04-02
STAAR VISION IMPLANTABLE COLLAMER LENS (P030016/S006)STAAR Surgical Company2009-04-02
ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S032)Cook, Inc.2009-04-02
PRECISION SPINAL CORD STIMULATOR SYSTEM (SCS) (P030017/S083)Boston Scientific Corp2009-04-02
VIRTUOSO ICDS (P980016/S185)Medtronic Cardiac Rhythm Disease Management2009-04-02
SYMPHONY SR/DR & RHAPSODY SR/DR & REPLY SR/DR (P950029/S043)MicroPort CRM USA, Inc.2009-04-02
OVATIO 6750 CRT-D (P060027/S012)MicroPort CRM USA, Inc.2009-04-02
CONCERTO ICRT-D (P010031/S148)Medtronic Cardiac Rhythm Disease Management2009-04-02
REPLY DR & SR (P950029/S042)MicroPort CRM USA, Inc.2009-04-02
PARADIGM REAL-TIME INSULIN PUMP & GUARDIAN REAL-TIME MONITOR (P980022/S049)Medtronic Minimed2009-04-02
CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D (P010031/S133)Medtronic Cardiac Rhythm Disease Management2009-04-01
SECURA ICD/MAXIMO II ICD/VIRTUOSO II DR/VR (P980016/S166)Medtronic Cardiac Rhythm Disease Management2009-04-01
DEFLUX INJECTABLE GEL (P000029/S042)Palette Life Sciences2009-04-01
RESTORE PRIME, PRIMEADVANCED, RESTORE RECHARGEABLE, RESTOREADVANCED RECHARGEABLE (P840001/S128)Medtronic Neuromodulation2009-04-01
MENTOR SALINE -FILLED & SPECTRUM BREAST IMPLANTS (P990075/S021)Mentor Worldwide, LLC2009-03-31
PROGRAMMER SOFTWARE (ICS 3000 802.U/2) (P950037/S067)Biotronik, Inc.2009-03-31
PROGRAMMER SOFTWARE (ICS 3000 802.U/2) (P000009/S032)Biotronik, Inc.2009-03-31
LIPOSORBER LA-15 SYSTEM (P910018/S012)Kaneka Pharma America Corp.2009-03-31
PROGRAMMER SOFTWARE (ICS 3000 802.U/2) (P980023/S036)Biotronik, Inc.2009-03-31
XACT CAROTID STENT SYSTEM (P040038/S016)Abbott Vascular, Inc.2009-03-31
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Every clearance here is in the API, with alerts when new ones post.