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Pfizer Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000042822

Devices
63
Registrations
EUDAMED
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA recalls

What Pfizer Inc. makes

The company manufactures disposable autoinjectors for growth hormone delivery, including replaceable-cartridge systems, as well as cardiovascular diagnostic software for interpretive screening. It also produces single-use medical consumables such as antiseptic skin preps, low-ionic-strength irrigation solutions, and adhesive barriers for wound care. Surgical and orthopedic tools are included, such as ACL drill guides, femoral bolts, and pleur-evacuation systems for autotransfusion. Additional offerings encompass ophthalmic solutions for lens care, enzymatic assay reagents, and continuous cardiac monitoring devices like Holter recorders.

The portfolio spans FDA-regulated devices classified as Class I, II, and III, with some unclassified (U) products. Authorisation pathways include 510(k) clearances, Premarket Approvals (PMA), and Unique Device Identifications (UDI) listings. The company is based in the United States, where all devices are subject to FDA oversight.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue63

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Company details

EUDAMED SRN
US-MF-000042822
DUNS number
079625650
EUDAMED status
Active
EUDAMED registered name
Pfizer, Inc.
Registered address
400, Webro Road, 07054, New Jersey, United States
Phone
+1 804 295 6494
PRRC contact
Charles Goldberg(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 21 Jul 2031

EUDAMED certificates (1)

Notified body 2797 1 certificate

  • MDR 727163 Issued

    Quality management system EU MDR

    Issued
    22 Jul 2026
    Expires
    21 Jul 2031

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 3 recalls initiated by PFIZER INC., initiated on 2018-10-02. By recorded status: 3 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 3
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2018

    • 2 Oct 2018 Z-0554-2019 Class II Terminated The firm received complaints of the wrap coming apart and leaking granular material Distribution: US Nationwide Distribution and PR
    • 2 Oct 2018 Z-0555-2019 Class II Terminated The firm received complaints of the wrap coming apart and leaking granular material Distribution: US Nationwide Distribution and PR
    • 2 Oct 2018 Z-0556-2019 Class II Terminated The firm received complaints of the wrap coming apart and leaking granular material Distribution: US Nationwide Distribution and PR

Frequently asked questions

How many devices does PFIZER INC. have in the registry?

The registry currently lists 63 devices for PFIZER INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list PFIZER INC.'s devices?

Among its 50 most recently registered devices, PFIZER INC. has devices listed in EUDAMED (1 device), FDA 510(k) (26 devices) and FDA GUDID (23 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do PFIZER INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for PFIZER INC.'s devices are Class I, Class IIa, Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for PFIZER INC.?

FDA recall records list 3 recalls initiated by PFIZER INC., the most recent initiated on 2018-10-02. 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 PFIZER INC.?

EUDAMED lists 1 certificate for PFIZER INC. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-07-22.

What are the newest devices from PFIZER INC. in the registry?

The most recently registered devices listed for PFIZER INC. include MedCheck, ThermaCare HeatWraps - Muscle & Joint, ThermaCare ColdWraps and ThermaCare HeatWraps.

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