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Boston Scientific Corp

3,562 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S055)Boston Scientific Corp2014-03-19
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S088)Boston Scientific Corp2014-03-14
PROMUS ELEMENT PLUS / PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S076)Boston Scientific Corp2014-03-14
PROMUS ELEMENT PLUS / PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S075)Boston Scientific Corp2014-03-13
PUNCTUA CRT-D, COGNIS, ENERGEN CRT-D, INCEPTA CRT-D (P010012/S346)Boston Scientific Corp2014-03-12
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEMS (P030017/S190)Boston Scientific Corp2014-03-07
PRECISION SPECTRA SYSTEM (P030017/S185)Boston Scientific Corp2014-03-07
AMS 700 SERIES INFATABLE PENILE PROSTHESIS (N970012/S097)Boston Scientific Corp2014-03-06
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S041)Boston Scientific Corp2014-03-05
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEM (P110010/S072)Boston Scientific Corp2014-02-27
FORMIO, VITALIO, ADVANTIO, INGENIO-- PACEMAKER (N970003/S158)Boston Scientific Corp2014-02-27
PRMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (CMS) (P110010/S074)Boston Scientific Corp2014-02-27
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PHATINUM CHROMIUM CORONARY STENT SYSTEM- (MES) (P110010/S073)Boston Scientific Corp2014-02-27
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S069)Boston Scientific Corp2014-02-27
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S071)Boston Scientific Corp2014-02-27
PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S070)Boston Scientific Corp2014-02-27
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S189)Boston Scientific Corp2014-02-25
PRECISION SPECTRA SYSTEM (P030017/S181)Boston Scientific Corp2014-02-16
TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S101)Boston Scientific Corp2014-02-13
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS- ELUTING STENT SYSTEM (P110010/S065)Boston Scientific Corp2014-02-13
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P110010/S058)Boston Scientific Corp2014-02-13
ROTABLATOR ROTATIONAL ANGIOPASTY SYSTEM GUIDEWIRE (P900056/S131)Boston Scientific Corp2014-02-13
BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S065)Boston Scientific Corp2014-02-13
FLEXTOME CUTTING BALLOON DILATATION DEVICE (P950020/S067)Boston Scientific Corp2014-02-13
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S108)Boston Scientific Corp2014-02-13
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S087)Boston Scientific Corp2014-02-13
ION PACLITAXEL-ELUTING C ORONAY STENT SYSTEM (P100023/S084)Boston Scientific Corp2014-02-13
EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S054)Boston Scientific Corp2014-02-13
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S068)Boston Scientific Corp2014-02-13
CHILLI COOLED ABLATION CATHETER AND CABLE (P980003/S046)Boston Scientific Corp2014-02-13
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S085)Boston Scientific Corp2014-02-06
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OTW) (P110010/S067)Boston Scientific Corp2014-02-06
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S083)Boston Scientific Corp2014-02-06
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEM (P110010/S066)Boston Scientific Corp2014-02-06
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE -WIRE) (P100023/S086)Boston Scientific Corp2014-02-06
ROTABLATOR ROTALINK ADVANCER AND ROTALINK PLUS (P900056/S130)Boston Scientific Corp2014-01-30
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S053)Boston Scientific Corp2014-01-29
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S187)Boston Scientific Corp2014-01-22
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S188)Boston Scientific Corp2014-01-22
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S107)Boston Scientific Corp2014-01-21
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S098)Boston Scientific Corp2014-01-02
AMS 800 URINARY CONTROL SYSTEM (P000053/S049)Boston Scientific Corp2014-01-02
PUNCTUA, ENERGEN INCEPTA COGNIS (P010012/S332)Boston Scientific Corp2013-12-23
PROMUS ELEMENT PLUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S063)Boston Scientific Corp2013-12-20
WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S050)Boston Scientific Corp2013-12-20
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S051)Boston Scientific Corp2013-12-20
ION PACLITAXEL-ELUTING CORONARY STENT SYTEM (P100023/S081)Boston Scientific Corp2013-12-20
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE SYSTEMS) (P100023/S082)Boston Scientific Corp2013-12-18
CORONARY FLEXTOME CUTTING BALLOON (P950020/S066)Boston Scientific Corp2013-12-18
BLAZER II, BLAZER II HTD,BLAZER PRIME HTD (P920047/S064)Boston Scientific Corp2013-12-18
WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S051)Boston Scientific Corp2013-12-18
EPIC VACULAR SELF EXPANDING STENT SYSTEM (P110035/S024)Boston Scientific Corp2013-12-18
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S064)Boston Scientific Corp2013-12-18
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S052)Boston Scientific Corp2013-12-18
PUNCTUA CRT-DS, COGNIS CRT-DS, ENERGEN CRT-D'S, INCEPTA CRT-DS (P010012/S344)Boston Scientific Corp2013-12-17
ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER (P900056/S129)Boston Scientific Corp2013-12-15
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S184)Boston Scientific Corp2013-12-13
PRECUSION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S183)Boston Scientific Corp2013-12-10
EASYTRAK 2,EASYTRAK 3,ACUITY SPIRAL CRTS (P010012/S343)Boston Scientific Corp2013-12-06
MAESTRO 3000 CARDIAC ABLATION SYSTEM (P980003/S045)Boston Scientific Corp2013-12-05
MAESTRO 3000 CARDIAC ABLATION SYSTEM (P920047/S063)Boston Scientific Corp2013-12-05
WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S049)Boston Scientific Corp2013-12-04
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S182)Boston Scientific Corp2013-12-04
ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S014)Boston Scientific Corp2013-12-02
COGNIS,ENERGEN,INCEPTA,PUNCTUA CRT-DS (P010012/S342)Boston Scientific Corp2013-11-26
FORMIO,VITALIO,ADVANTIO,INGENIO,ALTRUA,INSIGNIA PACEMAKERS (N970003/S157)Boston Scientific Corp2013-11-26
EPIC VASCULAR SELF EXPANDING STENT SYSTEM (P110035/S023)Boston Scientific Corp2013-11-24
PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S053)Boston Scientific Corp2013-11-21
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S022)Boston Scientific Corp2013-10-24
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S019)Boston Scientific Corp2013-10-23
CHILLI II COOLED ABLATION CATHETER (P980003/S043)Boston Scientific Corp2013-10-23
BLAZER II/ BLAZER PRIME HTD ABLATION CATHETERS (P920047/S062)Boston Scientific Corp2013-10-23
CORONARY FLEXTOME CUTTING BALLON (P950020/S065)Boston Scientific Corp2013-10-18
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S128)Boston Scientific Corp2013-10-18
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S127)Boston Scientific Corp2013-10-18
ION CORONARY STENT SYSTEM (P100023/S079)Boston Scientific Corp2013-10-18
WALLSTENT (TIPS) ENDOPROSTHESIS (P930031/S048)Boston Scientific Corp2013-10-18
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S061)Boston Scientific Corp2013-10-18
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S078)Boston Scientific Corp2013-10-18
CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S042)Boston Scientific Corp2013-10-18
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S062)Boston Scientific Corp2013-10-18
BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S061)Boston Scientific Corp2013-10-18
EXPRESS SD RENAL MONRAIL PREMOUNTED STENT SYSTEM (P060006/S050)Boston Scientific Corp2013-10-18
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S018)Boston Scientific Corp2013-10-18
EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S049)Boston Scientific Corp2013-10-18
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S021)Boston Scientific Corp2013-10-18
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S020)Boston Scientific Corp2013-10-18
ADVANTIO, INGENIO, VITALIO, FORMIO, INVIVE (N970003/S156)Boston Scientific Corp2013-10-10
CHILLI COOLED ABLATION SYSTEM (P980003/S041)Boston Scientific Corp2013-10-07
EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S060)Boston Scientific Corp2013-10-07
EPIC VASCULAR SELF EXPANDING STENT SYSTEM (P110035/S019)Boston Scientific Corp2013-09-27
ION PACLITAEL-ELUTING CORONARY STENT SYSTEM (P100023/S077)Boston Scientific Corp2013-09-27
ROTABLATOR ROTALIONAL ATHERECTOMY SYSTEM (P900056/S126)Boston Scientific Corp2013-09-27
FLEXTOME CUTTINGG BALLOON DILATATION DEVICE (P950020/S064)Boston Scientific Corp2013-09-27
BLAZER,BLAZER II HTD, AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS (P920047/S059)Boston Scientific Corp2013-09-27
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S048)Boston Scientific Corp2013-09-27
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S106)Boston Scientific Corp2013-09-27
PROMUS ELEMENT PLUS EVEROLIMUS ELUTING PLATINUM STENT SYSTEM (P110010/S060)Boston Scientific Corp2013-09-27
CHILLI II COOLED ABLATION CATHETER (P980003/S040)Boston Scientific Corp2013-09-27
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S017)Boston Scientific Corp2013-09-27
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Every clearance here is in the API, with alerts when new ones post.