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SHIPPERT MEDICAL TECHNOLOGIES, INC · Model 3-H-BA-DMC-14X23 · UDI-DI 00812185035797

LYA
10
510(k) clearances
202
Adverse events (3 deaths)
2
Recalls
105
Facilities

Recalls

DateFirmReason
2022-07-27GELITA MEDICAL GMBHIn routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
2006-07-11Porex Surgical, Inc.Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material

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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.