Skip to content

Pfizer Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000042822

Devices
63
Registrations
EUDAMED
FDA recalls
3

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

Newest first, rows 51-63 of 63

Search and filter all 63 devices
Skip device list

Rows 51-63 of 63

Showing 51-63 of 63

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.

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.

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