FDA Device Intelligence
Home › MEDEGEN MEDICAL PRODUCTS, LLC › Medegen Medical Products, LLC

Medegen Medical Products, LLC

MEDEGEN MEDICAL PRODUCTS, LLC · Model 17-0159-2 · UDI-DI 00700812003465

KME
10
510(k) clearances
69
Adverse events
2
Recalls
589
Facilities

Description

Drape: Sheet Wh 36X72 50/cs

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.