FDA Device Intelligence
HomeDEROYAL INDUSTRIES, INC. › DeRoyal

DeRoyal

DEROYAL INDUSTRIES, INC. · Model 903MR · UDI-DI 00749756170802

MHW Prescription
2
510(k) clearances
70
Adverse events (5 deaths)
5
Recalls
235
Facilities

Description

Glove, Edema

Recalls

DateFirmReason
2016-02-24Amd RitmedProduct does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
2006-08-16International Medsurg Connection, Inc.The bandages labeled as sterile had not been sterilized prior to distribution.
2006-08-16International Medsurg Connection, Inc.The bandages labeled as sterile had not been sterilized prior to distribution.
2006-08-16International Medsurg Connection, Inc.The bandages labeled as sterile had not been sterilized prior to distribution.
2006-08-16International Medsurg Connection, Inc.The bandages labeled as sterile had not been sterilized prior to distribution.

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.