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CEGA Innovations, Inc.

Cega Innovations, Inc. · Model MV2028 · UDI-DI 00850001780360

KMEFMR
10
510(k) clearances
64
Adverse events
2
Recalls
581
Facilities

Description

REMUV LP Single Patient Use (SPU) Air Transfer Mattress with Skin Integrity Pad (Approx. 36" W x 49" L)

Recalls

DateFirmReason
2023-06-23Microtek Medical Inc.Certain lots of the products have a Naphthalene odor.
2017-12-27LITTLE RAPIDS CORPORATIONThe secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer. The product is designed for patient trans

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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.