Atlas FDA

2006

1,074 FDA 510(k) clearances · PMA decision year

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◉ Watch 2006

RecordFirmDate
POWERLINK SYSTEM (P040002/S003)Endologix, LLC2006-02-01
DAKOCYTOMATION EGFR PHARMDX KIT (P030044/S001)Agilent Technologies, Inc.2006-02-01
C2A-TAPER ACETABULAR SYSTEM (P050009/S001)Biomet, Inc.2006-02-01
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S001)DePuy Orthopaedics, Inc.2006-02-01
CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S036)Corcym S.r.l.2006-02-01
IDENTITY/IDENTITY ADX, INTEGRITY, AFFINITY, AND ENTITY PULSE GENERATOR MODELS (P880086/S110)ABBOTT MEDICAL2006-01-31
ITREL3 (P840001/S084)Medtronic Neuromodulation2006-01-30
ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S008)Anika Therapeutics, Inc.2006-01-30
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S007)Beckman Coulter, Inc.2006-01-30
RESTYLANE INJECTABLE GEL (P040024/S004)Q-Med AB2006-01-27
NUCLEUS 24-COCHLEAR IMPLANT SYSTEM (P970051/S035)Cochlear Americas2006-01-27
LINOX SD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS (P980023/S020)Biotronik, Inc.2006-01-27
MOSAIC BIOPROSTHESIS MODELS 305 AND 310 (P990064/S013)Medtronic, Inc.2006-01-27
HANCOCK II BIOPROSTHESIS, MODELS T505 AND T510 (P980043/S008)Medtronic, Inc.2006-01-27
MEDTRONIC NEUROSTIMULATION SYSTEMS (RESTORE, SYNERGY, SYNERGY VERSITREL, SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+) (P840001/S088)Medtronic Neuromodulation2006-01-26
NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER (P990025/S009)Biosense Webster, Inc.2006-01-26
AMPLICOR HCV TEST, V2.0 (P000010/S005)Roche Molecular Systems, Inc.2006-01-25
COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S006)Roche Molecular Systems, Inc.2006-01-25
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S008)Roche Molecular Systems, Inc.2006-01-25
STAARVISC II, SHELLGEL AND COEASE (P000046/S013)Anika Therapeutics, Inc.2006-01-24
CARELINK MONITORS, MODELS 2490G AND 2490J (P890003/S084)Medtronic, Inc.2006-01-24
CARELINK MONITORS, MODELS 2490G AND 2490J (P980016/S050)Medtronic Cardiac Rhythm Disease Management2006-01-24
CARELINK MONITORS, MODELS 2490G AND 2490J (P010031/S022)Medtronic Cardiac Rhythm Disease Management2006-01-24
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S008)W. L. Gore & Associates, Inc.2006-01-20
CONTAK RENEWAL 3 (P010012/S090)Boston Scientific Corp2006-01-20
SUPARTZ (P980044/S003)Seikagaku Corp.2006-01-20
CONTAK RENEWAL 3 (P010012/S095)Boston Scientific Corp2006-01-20
CONTAK RENEWAL 3 (P010012/S088)Boston Scientific Corp2006-01-20
CONTAK RENEWAL TR (P030005/S028)Guidant Corp.2006-01-20
SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS (P990075/S015)Mentor Worldwide, LLC2006-01-20
RENEWAL (P010012/S094)Boston Scientific Corp2006-01-20
PHOTON, EPIC AND ATLAS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P910023/S090)ABBOTT MEDICAL2006-01-20
VITALITY, PRIZM (P960040/S105)Boston Scientific2006-01-20
LCS TOTAL KNEE SYSTEM (P830055/S094)Depuy, Inc.2006-01-20
VITALITY, PRIZM (P960040/S103)Boston Scientific2006-01-20
IBI CARDIAC ABLATION SYSTEM (P040014/S001)Irvine Biomedical, Inc.2006-01-20
PRIZM/VITALITY (P960040/S098)Boston Scientific2006-01-20
BIOGLUE SURGICAL ADHESIVE (P010003/S005)Cryolife, Inc.2006-01-20
VITALITY, PRIZM (P960040/S097)Boston Scientific2006-01-20
VITALITY (P960040/S102)Boston Scientific2006-01-20
DISCOVERY, MERIDIAN (P940031/S049)Boston Scientific2006-01-20
CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL 3 RF (P010012/S096)Boston Scientific Corp2006-01-20
PROLIEVE THERMODILATATION SYSTEM (P030006/S010)Medifocus, Inc.2006-01-20
CONTAK RENEWAL (P010012/S089)Boston Scientific Corp2006-01-20
VITALITY (P960040/S099)Boston Scientific2006-01-20
CONTAK RENEWAL, CONTAK RENEWAL 3 (P010012/S097)Boston Scientific Corp2006-01-20
FINELINE II / THINLINE II FAMILY OF LEADS (P960004/S032)Boston Scientific2006-01-19
CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE (P010012/S101)Boston Scientific Corp2006-01-19
CONTAK RENEWAL 3 RF (P010012/S092)Boston Scientific Corp2006-01-19
THINLINE II/ FINELINE II (P960004/S030)Boston Scientific2006-01-19
THINLINE 2 FINELINE 2 (P960004/S029)Boston Scientific2006-01-19
VITALITY, PRIZM (P960040/S107)Boston Scientific2006-01-19
RESTYLANE INJECTION GEL (P040024/S002)Q-Med AB2006-01-19
THINPREP 2000 SYSTEM (P950039/S016)Hologic, Inc.2006-01-18
VITALITY (P960040/S096)Boston Scientific2006-01-17
ATS MEDIAL HEART VALVE (P990046/S014)Medtronic Ats Medical, Inc.2006-01-17
FINELINE MODEL 6066 (P960004/S031)Boston Scientific2006-01-17
EASYTRAK LEADS (P010012/S091)Boston Scientific Corp2006-01-17
CONTAK RENEWAL 3 (P010012/S087)Boston Scientific Corp2006-01-17
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S050)Advanced Bionics2006-01-17
SECOND LOOK (P010038/S010)Icad, Inc.2006-01-13
CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC/ VALSALVA ASCENDING AORTIC PROSTHESIS (P900060/S035)Corcym S.r.l.2006-01-13
VENTAK FAMILY OF IMPLANTABLE CARIOVERTER DEFIBRILLATOR (P960040/S094)Boston Scientific2006-01-13
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S007)Ortho-Clinical Diagnostics, Inc.2006-01-12
CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S016)Cordis Corp.2006-01-12
GUIDANT EASY-TRACK 2 LEADS (P010012/S100)Boston Scientific Corp2006-01-11
MAVERICK FAMILY PTCA BALLOON CATHETERS, MAVERICK OTW, MAVERICK2 MONORAIL (MR), QUANTUM MAVERICK OTW AND QUANTUM MAVERICK (P860019/S206)Scimed Life Systems, Inc.2006-01-10
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P910023/S091)ABBOTT MEDICAL2006-01-10
ON-X PROSTHETIC HEART VALVE (P000037/S010)On-X Life Technologies, Inc.2006-01-10
FLOSEAL HEMOSTATIC MATRIX (P990009/S017)Baxter Healthcare Corp2006-01-10
TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S024)Boston Scientific Corp2006-01-06
ON-X PROSTHETIC HEART VALVE (P000037/S009)On-X Life Technologies, Inc.2006-01-06
MEDTRONIC SYNCHROMED INFUSION SYSTEM (P860004/S080)Medtronic, Inc.2006-01-06
MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S022)Medtronic Vascular2006-01-04
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Every clearance here is in the API, with alerts when new ones post.