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Shockwave Medical Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000012770

Devices
115
Registrations
EUDAMEDFDA
FDA recalls
1

Catalogue115

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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
Phone
1-877-775-4846
PRRC contact
Peter Nowakowski(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredMDR 2next expiry 17 Aug 2027

EUDAMED certificates (2)

BSI Group The Netherlands B.V. 2797 2 certificates

  • MDR 728473 Expiring Supplemented Expires in 289 days

    Quality management system EU MDR

    Issued
    22 Jun 2026
    Expires
    17 Aug 2027
    Reason
    Change approved
  • MDR 728474 Expiring Supplemented Expires in 289 days

    Technical documentation EU MDR

    Issued
    22 Jun 2026
    Expires
    17 Aug 2027
    Reason
    Add device or group

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

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).via FDA establishment SHOCKWAVE MEDICAL, INC. Distribution: Domestic: CO, TN and TX Foreign: Austria, Germany and New Zealand Submission number: K180454

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Shockwave Medical, Inc. Santa Clara, CA · US FEI 3015053858

From the company website

Read 14 Oct 2026

From IVL to coronary sinus reduction, Shockwave Medical is transforming standards of care and driving better outcomes for underserved patients.

From the manufacturer's own website. Source

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.

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.

Which FDA establishments are linked to Shockwave Medical Inc.?

1 FDA establishment is linked to Shockwave Medical Inc. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.