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Data / Medical devices / Ireland / Boston Scientific Limited

Boston Scientific Limited: FDA-registered device maker in CLONMEL Tipperary, Ireland, 13 510(k) clearances and 9 PMA approvals

Boston Scientific Limited is registered with the FDA (registration 9616693) in CLONMEL Tipperary, Ireland. It lists 25 device types. The FDA files 13 510(k) clearances and 9 PMA approvals under its listings, the newest dated March 27, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Boston Scientific Limited
FDA registration number
9616693
FEI number
3002618605
Address
Cashel Road, CLONMEL Tipperary, Ireland, --
Owner or operator
Boston Scientific Corporation (9912058)
Roles
Manufacturer
First device listed
November 19, 2007
Registered through
2026
Brand names listed
2x8 Contact Lead Extension Kit, 8 Contact Extension Kit, AC/DC Power Supply, ACCOLADE, ACCOLADE MRI, ACUITY Spiral, ACUITY X4 Flushing Tool/Wire Guide, ACUITY X4 Spiral and more

Devices it lists

DeviceProduct codeClassRoleSource
Camera, Surgical And AccessoriesKQM1Manufactureraccessdata.fda.gov
Choledochoscope And Accessories, Flexible/RigidFBN2Manufactureraccessdata.fda.gov
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK3Manufactureraccessdata.fda.gov
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX3Manufactureraccessdata.fda.gov
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN3Manufactureraccessdata.fda.gov
Generator, Lesion, RadiofrequencyGXD2Manufactureraccessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)LWS3Manufactureraccessdata.fda.gov
Implantable Pulse Generator, Pacemaker (Non-Crt)LWP3Manufactureraccessdata.fda.gov
Insufflator, HysteroscopicHIG2Manufactureraccessdata.fda.gov
Led Light SourceNTN2Manufactureraccessdata.fda.gov
Pacemaker/Icd/Crt Non-Implanted ComponentsOSR3Manufactureraccessdata.fda.gov
Permanent Defibrillator ElectrodesNVY3Manufactureraccessdata.fda.gov
Permanent Pacemaker ElectrodeDTB3Manufactureraccessdata.fda.gov
Probe, Radiofrequency LesionGXI2Manufactureraccessdata.fda.gov
Programmer, PacemakerKRG3Manufactureraccessdata.fda.gov
Prosthesis, PenileFAE2Manufactureraccessdata.fda.gov
Prosthesis, Spinous Process Spacer/PlateNQO3Manufactureraccessdata.fda.gov
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE3Manufactureraccessdata.fda.gov
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)MXD2Manufactureraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Essential TremorPJS3Manufactureraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian SymptomsNHL3Manufactureraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY3Manufactureraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW3Manufactureraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyQRB3Manufactureraccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 27, 2026K251273Asurys Fluid Management SystemHIGSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
September 12, 2025K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)MXDSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
August 7, 2025K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)GXDSubstantially EquivalentBoston Scientific Neuromodulation Corporationaccessdata.fda.gov
July 1, 2024K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500)FGBSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
August 19, 2023K231328LUX-Dx II (M302); LUX-Dx II+ (M312)MXDSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
May 25, 2021K210608LUX-Dx Insertable Cardiac MonitorMXDSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 26, 2020K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - USMXDSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
May 21, 2020K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerFBNSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
April 16, 2019K183619Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm DeviceFAESubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
January 22, 2019K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital ControllerFBNSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
November 13, 2015K153049LithoVue SystemFGBSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
October 16, 2008K082051COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4GXDSubstantially EquivalentCosman Medical, Inc.accessdata.fda.gov
March 17, 2005K050084COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;GXISubstantially EquivalentCosman Medical, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
December 8, 2017P150031VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMNHL94October 15, 2026accessdata.fda.gov
April 25, 2016P150012IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADLWP186October 3, 2026accessdata.fda.gov
May 20, 2015P140004SUPERION INTERSPINOUS SPACERNQO33November 7, 2024accessdata.fda.gov
September 28, 2012P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMLWS208October 2, 2026accessdata.fda.gov
April 27, 2004P030017PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMLGW373September 22, 2026accessdata.fda.gov
January 26, 2004P030005CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARENKE244October 3, 2026accessdata.fda.gov
May 2, 2002P010012CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLLNIK580August 25, 2026accessdata.fda.gov
June 3, 1999N970003PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARELWP160October 3, 2026accessdata.fda.gov
July 18, 1997P960040VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEMLWS485August 25, 2026accessdata.fda.gov

Compare with other makers

Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.