Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
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., part of Johnson & JohnsonLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record. See the Johnson & Johnson group view.
As of Nov 15, 2026, FDA's public records list Shockwave Medical with 13 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jul 27, 2026: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Ca….
510(k) clearances: 13
Device recalls: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
02017Records0
320182018Records3vs 2017+3
12019Records1vs 2018−2
020202020Records0vs 2019−1
12021Records1vs 2020+1
220222022Records2vs 2021+1
02023Records0vs 2022−2
320242024Records3vs 2023+3
12025Records1vs 2024−2
120262026 to dateRecords1
Latest Records
Newest first across sources; each opens the record
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
