Shockwave Medical Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000012770
- Devices
- 115
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA establishment, FDA recalls
Catalogue
Search and filter all 115 devicesShowing 1-50 of 115
Company details
- EUDAMED SRN
- US-MF-000012770
- SRN (system / procedure pack)
- US-PR-000012771
- DUNS number
- 055514478
- EU VAT number
- NL824252871B01
- EUDAMED status
- Active
- EUDAMED registered name
- Shockwave Medical Inc.
- EUDAMED abbreviated name
- SWMI
- Registered address
- 5403, Betsy Ross Drive, 95054, Santa Clara, CA, United States
- Website
- shockwavemedical.com/
- [email protected]
- Phone
- 1-877-775-4846
- PRRC contact
- Peter Nowakowski
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 17 Aug 2027
BSI Group The Netherlands B.V. 2797 2 certificates
- MDR 728473 Expiring
Quality management system EU MDR
- Issued
- 22 Jun 2026
- Expires
- 17 Aug 2027
- Reason
- Change approved
- MDR 728474 Expiring
Technical documentation EU MDR
- Issued
- 22 Jun 2026
- Expires
- 17 Aug 2027
- Reason
- Add device or group
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 18 Jul 2018 Z-3247-2018 Class II Terminated Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
FDA establishments
- Shockwave Medical, Inc. Santa Clara, CA · US FEI 3015053858
From the company website
From IVL to coronary sinus reduction, Shockwave Medical is transforming standards of care and driving better outcomes for underserved patients.
Frequently asked questions
How many devices does Shockwave Medical Inc. have in the registry?
The registry currently lists 115 devices for Shockwave Medical Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shockwave Medical Inc.'s devices?
Among its 50 most recently registered devices, Shockwave Medical Inc. has devices listed in EUDAMED (42 devices), FDA 510(k) (1 device) and FDA GUDID (19 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Shockwave Medical Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Shockwave Medical Inc.'s devices are Class IIb, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Shockwave Medical Inc.?
FDA recall records list 1 recall initiated by Shockwave Medical Inc., the most recent initiated on 18 Jul 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Shockwave Medical Inc.?
EUDAMED lists 2 certificates for Shockwave Medical Inc. (quality management system; technical documentation) under MDR. The most recent was issued on 22 Jun 2026.
What are the newest devices from Shockwave Medical Inc. in the registry?
The most recently registered devices listed for Shockwave Medical Inc. include Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Catheter, Shockwave E8 Peripheral Intravascular Lithotripsy (IVL) Catheter, Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Catheter and Shockwave L6 Peripheral Intravascular Lithotripsy (IVL) Catheter.