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HomeCURBELL MEDICAL PRODUCTS, INC. › 800 P37,JE

800 P37,JE

CURBELL MEDICAL PRODUCTS, INC. · Model BIC-19C0-E04-8 · UDI-DI 00840828123785

FNL
10
510(k) clearances
93,774
Adverse events (647 deaths)
155
Recalls
235
Facilities

Description

800 P37,JE

Recalls

DateFirmReason
2026-05-04KAYSERBETTEN GMBH & CO. KGIf the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased ris
2024-09-18Baxter Healthcare CorporationThe beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.