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Sign in to claim this brandWelch Allyn, Inc.
United States·US-MF-000013394
Last updated September 17, 2026
What Welch Allyn, Inc. makes
Welch Allyn, Inc. manufactures professional multichannel electrocardiographs, reusable blood pressure cuffs, and cardiopulmonary stress testing systems. Their portfolio also includes general-purpose and centralized bedside monitors for clinical use, as well as ophthalmic and otologic diagnostic tools. The company produces monitoring systems for multiple physiological parameters and patient health record software applications.
The company’s devices are classified under Class I and Class II regulations, with listings in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. Welch Allyn, Inc. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 4341, State Street Road, Skaneateles Falls, New York, United States
- Website
- www.baxter.com/
- —
- —
- [email protected]
- Phone
- +1 484-949-1130
- PRRC Contact
- —
- EUDAMED SRN
- US-MF-000013394
- FDA FEI Number
- 1316463
- DUNS Number
- 198227881
Catalogue (5347)
Page 10 of 107| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Welch Allyn, Inc. | 901130 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901066 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901027 | FDA UDI | Class I | Unknown |
| Welch Allyn, Inc. | 901132 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901023 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901133 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901042 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901144 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901194 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901056 | FDA UDI | Class II | Unknown |
| Welch Allyn, Inc. | 901027 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901144 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901043 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901060 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901140 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901044 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901129 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901012 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901130 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901060 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901043 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901128 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901132 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901044 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901007 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901044 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901129 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901091 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901044 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901053 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901043 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901095 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901090 | FDA UDI | Class II | Unknown |
| Welch Allyn, Inc. | 901001 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901055 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901057 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901132 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901060 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901131 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901144 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901043 | FDA UDI | Class II | Unknown |
| Welch Allyn, Inc. | 901144 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901144 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901044 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901131 | FDA UDI | Class II | Unknown |
| Welch Allyn, Inc. | 901144 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901006 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901044 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901044 | FDA UDI | Class II | Active |
| Welch Allyn, Inc. | 901069 | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
Importers
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Notified Bodies
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FDA Recalls (17)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Welch Allyn, Inc. has 17 recall records initiated between October 27, 2003, and July 20, 2021. The records include open, classified, and terminated statuses, with reasons involving potential device malfunctions such as fluid ingress risks leading to overheating or electrical shorts, mechanical errors affecting cuff placement or calibration, battery charging defects, incorrect power cord connections, and manufacturing deficiencies.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 20, 2021 | Z-2482-2021 | — | open, classified | If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient |
| Apr 22, 2021 | Z-1672-2021 | — | terminated | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock |
| Apr 22, 2021 | Z-1673-2021 | — | terminated | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock |
| Feb 27, 2017 | Z-1777-2017 | — | terminated | A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. This potential defect resides with the device, not the battery. The over-voltage condition can result in high NiMH battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components. |
| Oct 2, 2015 | Z-0169-2016 | — | terminated | The firm became aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator. This may result in a shattered lamp bulb and a potential electric shock hazard. |
| Mar 1, 2004 | Z-0748-04 | — | terminated | GMP deficiencies |
| Mar 1, 2004 | Z-0752-04 | — | terminated | GMP deficiencies |
| Mar 1, 2004 | Z-753-04 | — | terminated | GMP deficiencies |
| Mar 1, 2004 | Z-0749-04 | — | terminated | GMP deficiencies |
| Mar 1, 2004 | Z-0751-04 | — | terminated | GMP deficiencies |
| Mar 1, 2004 | Z-0755-04 | — | terminated | GMP deficiencies |
| Mar 1, 2004 | Z-0756-04 | — | terminated | GMP deficiencies |
| Mar 1, 2004 | Z-0754-04 | — | terminated | GMP deficiencies |
| Mar 1, 2004 | Z-0750-04 | — | terminated | GMP deficiencies |
| Mar 1, 2004 | Z-0757-04 | — | terminated | GMP deficiencies |
| Dec 30, 2003 | Z-0354-04 | — | terminated | Mechanical setting errors that result in calibration errors. |
| Oct 27, 2003 | Z-0244-04 | — | terminated | Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading. |