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Universal Filter

SBI PHARMACEUTICALS CO., LTD. · Model 220-25 · UDI-DI 04560304635774

FEM
4
510(k) clearances
698
Adverse events
5
Recalls
63
Facilities

Recalls

DateFirmReason
2023-07-21Ambu Inc.Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device
2019-06-10Olympus Corporation of the AmericasWM-NP/DP2 workstations could become unstable and may fall over if the control panel arm is mounted with a video monitor weighing more than 19.8 pounds.
2011-10-28Olympus America Inc.Replacement wheels may break off from the base of the cart
2003-10-10Smith And Nephew, Inc. Endoscopy DivisionHardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
2003-10-10Smith And Nephew, Inc. Endoscopy DivisionHardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.

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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.