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Ameda, Inc.

United StatesFDA applicant, unverified FDA FEI 3009974348

Ameda, Inc. is a medical device manufacturer, with 102 devices listed in FDA GUDID and FDA 510(k) (FDA Class II, Class I and Unclassified) and 3 FDA recalls as of 14 Nov 2026.

Devices
102
Registrations
FDA
FDA recalls
30 ongoing since 2021 (1 open in total)
1 open since before 2021

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 100
  • FDA 510(k) 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 88
  • FDA Class I 12
  • FDA Unclassified 2
FDA recalls
Identifiers
  • FDA FEI 3009974348
  • DUNS 078719435

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

Catalogue102

Newest first, rows 1-50 of 102

Search and filter all 102 devices
Skip device list

  • Ameda, Inc. 17148PM

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc 10004

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17115

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 10002

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17508RT

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17608

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17155

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17071 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17244M Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17158

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda True Protect

    Listed Registry: GUDID Class:I

  • Ameda Mya Joy PLUS

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17803LRT

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17242M Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17147M

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 20001

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17141

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Ameda, Inc. 201X13

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17076PM Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda Mya Joy PLUS

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17079M Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda 17070P Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 700P

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Ameda, Inc. 17212

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda Mya Joy

    Listed Registry: GUDID Class:II

  • Ameda, Inc. 201W23

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 10005

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17105

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17803

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17084 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17153

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17112

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17085B Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17086 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17083 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17085MT Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17064M

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Ameda, Inc. 17803LRTR

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17069P

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Ameda, Inc. 17608LRTR

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 201X10

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17245 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 10010

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 30001

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 201W01H

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda Mya Joy PLUS

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17243M Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17450

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Ameda, Inc. 17093

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Ameda, Inc. 17156

    Active Regimes: 510(k) Registry: GUDID Class:II

Rows 1-50 of 102

Showing 1-50 of 102

Company details

FDA FEI number
3009974348
DUNS number
078719435
Address
8206 Cross Park Dr, Austin, TX, 78754
Phone
866-992-6332

FDA recalls3

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

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

2 initiated before 2017

  • 2017

    • 10 Jul 2017 Z-0616-2018 Class III Open since 2017 Two specific lots was incorrectly manufactured containing a UK power adapter. Distribution: Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA. Submission number: K973501

  • 2015

    • 12 Feb 2015 Z-1326-2015 Class II Terminated Devices were not sterilized Distribution: Nationwide Distribution including CA, FL, GA, IA, IL, IN, LA, MA, MD, MO, MS, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT,…
      Full distribution text Nationwide Distribution including CA, FL, GA, IA, IL, IN, LA, MA, MD, MO, MS, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WA.
      Submission number: K912355
    • 12 Feb 2015 Z-1327-2015 Class II Terminated Devices were not sterilized Distribution: Nationwide Distribution including CA, FL, GA, IA, IL, IN, LA, MA, MD, MO, MS, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT,…
      Full distribution text Nationwide Distribution including CA, FL, GA, IA, IL, IN, LA, MA, MD, MO, MS, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WA.
      Submission number: K011519

Frequently asked questions

How many devices does Ameda, Inc. have in the registry?

The registry currently lists 102 devices for Ameda, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ameda, Inc.'s devices?

Among its 50 most recently registered devices, Ameda, Inc. has devices listed in FDA GUDID (50 devices).

What risk classes do Ameda, Inc.'s devices fall under?

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

Are there FDA recall records for Ameda, Inc.?

FDA recall records list 3 recalls initiated by Ameda, Inc., the most recent initiated on 10 Jul 2017. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Ameda, Inc. in the registry?

The most recently registered devices listed for Ameda, Inc. include Ameda, Inc. 17148PM, Ameda, Inc 10004, Ameda, Inc. 17115 and Ameda, Inc. 10002.

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