Atlas FDA

2008

1,491 FDA 510(k) clearances · PMA decision year

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◉ Watch 2008

RecordFirmDate
RIATA FAMILY OF HIGH VOLTAGE LEADS (P950022/S051)ABBOTT MEDICAL2008-07-31
SJM PACEMAKERS (P030035/S039)ABBOTT MEDICAL2008-07-31
EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S097)ABBOTT MEDICAL2008-07-31
SJM PACEMAKERS (P880086/S160)ABBOTT MEDICAL2008-07-31
TENDRIL FAMILY F LOW VOLTAGE LEADS (P960013/S037)ABBOTT MEDICAL2008-07-31
AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) (P000053/S018)Boston Scientific Corp2008-07-31
T SPOT-TB TEST (P070006)Oxford Immunotec, Ltd.2008-07-30
COAPTITE INJECTABLE IMPLANT (P040047/S006)Merz North America, Inc.2008-07-30
ACRYSOF RESTOR SINGLE-PIECE INTRAOCULAR LENSES (P040020/S011)Alcon Research, Ltd.2008-07-30
RADIESSE INJECTABLE IMPLANT (P050052/S010)Merz North America, Inc.2008-07-30
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S067)Boston Scientific Corp2008-07-30
GE HEALTHCARE SENOGRAPHE 2000D DIGITAL MAMMOGRAPHY SYSTEM (P990066/S032)GE Healthcare2008-07-30
RADIESSE INJECTABLE IMPLANT (P050037/S009)Merz North America, Inc.2008-07-30
GENESIS NEUROSTIMULATION (IPG) SYSTEM (P010032/S026)ABBOTT MEDICAL2008-07-29
SILICONE UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P880091/S025)Staar Surgical Co.2008-07-29
MENTOR SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE BREAST IMPLANTS (P990075/S019)Mentor Worldwide, LLC2008-07-28
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S012)Beckman Coulter, Inc.2008-07-28
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S046)Boston Scientific Corp2008-07-25
VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR ICD (P980016/S134)Medtronic Cardiac Rhythm Disease Management2008-07-25
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S005)Smith & Nephew, Inc.2008-07-25
TELIGEN FAMILY (P960040/S171)Boston Scientific2008-07-25
TRILOGY AB ACETABULAR SYSTEM (P040048/S004)Zimmer, Inc.2008-07-25
SURGIFOAM ABSORBABLE GELATIN SPONGE & U.S.P./SURGIFLO HEMOSTATIC MATRIX (P990004/S014)Ferrosan Meidcal Devices A/S2008-07-25
REPLY PACEMAKERS (P950029/S032)MicroPort CRM USA, Inc.2008-07-25
COGNIS FAMILY (P010012/S185)Boston Scientific Corp2008-07-25
CONCERTO CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S103)Medtronic Cardiac Rhythm Disease Management2008-07-25
MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S001)Corcym Canada Corp2008-07-25
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S041)Boston Scientific Corp2008-07-24
COAPTITE INJECTABLE IMPLANT (P040047/S007)Merz North America, Inc.2008-07-24
TELIGEN ICD PULSE GENERATORS (P960040/S170)Boston Scientific2008-07-23
COGNIS CRT-D PULSE GENERATORS (P010012/S184)Boston Scientific Corp2008-07-23
SYMPHONY DR/SR & ELA RHAPSODY +DR/DR/SR (P950029/S037)MicroPort CRM USA, Inc.2008-07-23
OVATIO VR & DR (P980049/S038)MicroPort CRM USA, Inc.2008-07-23
OVATIO CRT (P060027/S003)MicroPort CRM USA, Inc.2008-07-23
STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEMS (P050007/S010)Abbott Vascular Devices2008-07-23
RESTYLANE INJECTABLE GEL (P040024/S025)Q-Med AB2008-07-23
MYNX VASCULAR CLOSURE DEVICE (P040044/S008)Cordis US Corporation2008-07-22
DEFLUX INJECTABLE GEL (P000029/S021)Palette Life Sciences2008-07-21
CONTAK RENEWAL TR (P030005/S053)Guidant Corp.2008-07-18
CONTAK RENEWAL/VITALITY (P010012/S181)Boston Scientific Corp2008-07-18
VIGOR DR/SR & DISCOVER/MERIDIAN, PDP (P940031/S064)Boston Scientific2008-07-18
INSYNC III (P010015/S045)Medtronic, Inc.2008-07-18
PRIZM/VITALITY (P960040/S169)Boston Scientific2008-07-18
MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATORS (IPG) PRODUCT FAMILY (P980035/S101)Medtronic, Inc.2008-07-18
KAPPA 400 DR/SR (P970012/S035)Medtronic, Inc.2008-07-18
CONCERTO (P010031/S099)Medtronic Cardiac Rhythm Disease Management2008-07-18
KAPPA/ENPULSE II/ADAPTA/VERSA/SENIA (P980035/S100)Medtronic, Inc.2008-07-18
VENTAK MINI & CONTAK RENEWAL 3 (P910077/S089)Boston Scientific2008-07-18
VIRTUOSO DR/VR (P980016/S130)Medtronic Cardiac Rhythm Disease Management2008-07-18
EPICARDIAL TRANSVENE LEAD AND RELATED ACCESSORIES (P900061/S076)Medtronic Cardiac Rhythm Disease Management2008-07-17
CADENCE FAMILY OF ICDS (P910023/S182)ABBOTT MEDICAL2008-07-17
BIO-RAD MONOLISA ANTI-HBS EIA & ANTI-HBS CALIBRATOR KIT (P050048/S001)Bio-Rad Laboratories2008-07-17
LEADS SERVICE KIT & LEADS WRENCH KIT (P890003/S142)Medtronic, Inc.2008-07-17
CAPSURE EPI UNIPOLAR & BIPOLAR LEAD (P950024/S011)Medtronic, Inc.2008-07-17
LEAD ASSEMBLY (P030036/S007)Medtronic Cardiac Rhythm Disease Management2008-07-17
GST (MINILINK TRANSMITTER) & GSR (CGMS I PRO RECORDER) (P980022/S030)Medtronic Minimed2008-07-17
MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S023)Medtronic Minimed2008-07-17
MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S029)Medtronic Minimed2008-07-17
EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S096)ABBOTT MEDICAL2008-07-17
LEAD ASSEMBLY (P010015/S044)Medtronic, Inc.2008-07-17
CGMS IPRO SYSTEM (P980022/S028)Medtronic Minimed2008-07-17
SVC/CS TRANSVENE LEAD (P980050/S034)Medtronic, Inc.2008-07-17
VARIOUS FAMILY OF LEADS (P920015/S046)Medtronic, Inc.2008-07-17
ST JUDE MECHANICAL HEART VALVE (P810002/S066)ABBOTT MEDICAL2008-07-16
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S025)CooperSurgical, Inc.2008-07-16
POLYMETHYLMETHA-CRYLATE INTRAOCULAR LENSES (P880090/S025)Bausch & Lomb, Inc.2008-07-16
LCS TOTAL KNEE SYSTEM ¿ MBT REVISION TIBIAL TRAYS (P830055/S103)Depuy, Inc.2008-07-16
SILICONE INTRAOCULAR LENSES (P910061/S017)Bausch & Lomb2008-07-16
UROLOGIX PROSTATRON SYSTEM (P950014/S026)Urologix, Inc.2008-07-16
OCUCOAT (P860047/S022)Bausch & Lomb, Inc.2008-07-16
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S031)GE Healthcare2008-07-16
APLIGRAF (P950032/S048)Organogenesis, Inc.2008-07-16
POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES (P840039/S057)Bausch & Lomb, Inc.2008-07-16
DEXCOM SEVEN SYSTEM (P050012/S015)Dexcom, Inc.2008-07-16
RESTYLANE INJECTABLE GEL (P040024/S024)Q-Med AB2008-07-15
RESTYLANE INJECTABLE GEL (P040024/S026)Q-Med AB2008-07-15
HANCOCK II BIOPROSTHESIS (P980043/S017)Medtronic, Inc.2008-07-15
AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S005)ABBOTT MEDICAL2008-07-15
AMPLATZER DUCT OCCLUDER (P020024/S020)ABBOTT MEDICAL2008-07-15
AMPLATZER SEPTAL OCCLUDER & MULTI-FENESTRATED SEPTAL OCCLUDER CRIBRIFORM (P000039/S026)ABBOTT MEDICAL2008-07-15
MEDTRONIC VASCULAR TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S001)Medtronic Vascular2008-07-15
MOSAIC PORCINE BIOPROSTHESIS (P990064/S024)Medtronic, Inc.2008-07-15
MEDTRONIC CONSULTA & MAXIMO ICDS (P010031/S096)Medtronic Cardiac Rhythm Disease Management2008-07-11
CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (P030002/S016)Bausch & Lomb, Inc.2008-07-11
RADIESSE INJECTABLE IMPLANT (P050052/S009)Merz North America, Inc.2008-07-11
VARIOUS MODELS OF PHILOS/PHILOS, AXIOS, PROTOS PULSE GENERATOR (P950037/S057)Biotronik, Inc.2008-07-11
STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER (P990013/S021)Starr Surgical Co.2008-07-11
MEDTRONIC SECURA & MAXIMO II ICDS (P980016/S127)Medtronic Cardiac Rhythm Disease Management2008-07-11
SECURA DR/VR & MAXIMO II DR/VR (P980016/S137)Medtronic Cardiac Rhythm Disease Management2008-07-11
STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER (P030016/S008)STAAR Surgical Company2008-07-11
RADIESSE INJECTABLE IMPLANT (P050037/S008)Merz North America, Inc.2008-07-11
CONSULTA CRT-D & MAXIMO II CRT-D (P010031/S106)Medtronic Cardiac Rhythm Disease Management2008-07-11
RESTOREULTRA RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (P840001/S115)Medtronic Neuromodulation2008-07-11
2490C CARELINK MONITOR (P890003/S140)Medtronic, Inc.2008-07-10
COMBI 40+COCHLEAR IMPLANT SYSTEM (P000025/S017)Med-El Corp.2008-07-10
VIRTUOSO (P980016/S136)Medtronic Cardiac Rhythm Disease Management2008-07-10
CARPENTIER-SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S016)Edwards Lifesciences, LLC2008-07-10
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S017)Edwards Lifesciences, LLC2008-07-10
CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL BIOPROSTHESIS (P860057/S048)Edwards Lifesciences, LLC2008-07-10
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S028)Edwards Lifesciences, LLC2008-07-10
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Track 2008 automatically

Every clearance here is in the API, with alerts when new ones post.