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I-MED Single Use Face Mask

I-Med Pharma Inc · Model 5300 · UDI-DI 00622554053006

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10
510(k) clearances
50
Adverse events
1
Recalls
719
Facilities

Description

Single-use face shield is intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer

Recalls

DateFirmReason
2008-06-05Phillips Safety ProductsRadiation Protective Eyewear does not meet the radiation protection levels stated on the labeling.

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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.