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I-MED Surgical Mask

I-Med Pharma Inc · Model 5100 · UDI-DI 00622554051002

QKR
0
510(k) clearances
225
Adverse events
1
Recalls
269
Facilities

Description

Mask 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
2020-07-21BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIADisposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.

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

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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.