Boston Scientific
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 10 spellings of its name, each linked to the record.
- Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 2,678, 56 entities
- 510(k) clearances: 1,912
- Device recalls: 759
- Drug applications: 6
- AI-enabled devices: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Boston Scientific and its 55 subsidiaries
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Sep 11, 2026 | SpaceOAR Flex SystemK262151 · OVB | 510(k) clearances |
| Sep 3, 2026 | Rezum SystemK262460 · KNS | 510(k) clearances |
| Aug 26, 2026 | LithoVue Elite Digital Flexible Ureteroscope SystemK261153 · FGB | 510(k) clearances |
| Aug 21, 2026 | AVVIGO+ Multi-Modality Guidance SystemK253692 · DQK | 510(k) clearances |
| Aug 12, 2026 | EluPro Antibiotic-Eluting BioEnvelopeK262406 · FTM | 510(k) clearances |
| Aug 4, 2026 | Navigator Flex Ureteral Access Sheath SetK261915 · FED | 510(k) clearances |
| Jul 24, 2026 | FARADRIVE Steerable Sheath (M004PF21M402)K262165 · DRA | 510(k) clearances |
| Jul 24, 2026 | OBSIDIO Conformable EmbolicK261488 · KRD | 510(k) clearances |
| Jan 23, 2026 | BodyGuardian Remote Monitoring System (BGRMS v3.0)K243349 · Cardiovascular | AI-enabled devices |
| Jun 3, 2021 | BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476Class II · Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized | Device recalls |
Subsidiaries and Divisions
55 firms in the Boston Scientific group, most records first- Intermedics211 records
- Scimed Life Systems109 records
- Advanced Cardiovascular Systems, Inc.103 records
- Guidant86 records
- Cardiac Pacemakers, Inc.76 records
- Target Therapeutics70 records
- Baylis Medical Company60 records
- Meadox Medicals53 records
- Boston Scientific Cork41 records
- Boston Scientific Neuromodulation35 records
- Boston Scientific Scimed35 records
- Galil Medical33 records
- EKOS31 records
- EndoChoice28 records
- Boston Scientific, Target19 records
- Cardiovascular Imaging Systems, Inc.19 records
- Microvasive18 records
- NeoTract, Inc.18 records
- Apollo Endosurgery15 records
- Bridgepoint Medical15 records
- EP Technologies, Inc.15 records
- Arstasis14 records
- Vitaphore13 records
- BTG International12 records
- Radiotherapeutics Corporation12 records
- C2 Therapeutics11 records
- Lumend, Inc.11 records
- Relievant Medsystems10 records
- Boston Scientific CRM Corp8 records
- Cardiothoracic Systems8 records
- Guidant Corporation Cardiac Surgery8 records
- Scimed8 records
- Scimed Peripheral Interventions8 records
- Broncus Medical7 records
- Guidant Cardiac and Vascular Surgery7 records
- Axonics6 records
- Baylis Medical Technologies5 records
- Boston Scientific/Medi-Tech5 records
- Cardiac Pathways5 records
- Schneider (Europe) GmbH5 records
- Heart Technology4 records
- Boston Scientific - Precision Vascular3 records
- Rhythmia Medical3 records
- Boston Scientific Cardiac Diagnostic Technologies2 records
- Boston Scientific Corporation Northwest Technology2 records
- Boston Scientific Epi2 records
- Boston Scientific IVT2 records
- CryoCor, Inc.2 records
- Asthmatx1 record
- Axonics Modulation Technologies1 record
- Biocompatibles UK Ltd (Part of Boston Scientific Corporation1 record
- Boston Endo-Surgical Technologies, Inc.1 record
- Boston Scientific EP Technologies1 record
- Guidant Endovascular Solutions1 record
- PneumRx, Inc.1 record
Canada and Imports
Across the Boston Scientific group, matched by company nameNames and Identifiers
- Appears as
- Website
- bostonscientific.com
- Wikidata
- Q140351185
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built