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Epimed

EPIMED INTERNATIONAL, INC · Model 410-156P · UDI-DI 00818788022752

GXH Prescription
10
510(k) clearances
52
Adverse events (1 deaths)
2
Recalls
10
Facilities

Description

PainBlocker™ 15g x 6" Bevel Point Cryoneuroablation Probe

Recalls

DateFirmReason
2015-07-01Myoscience IncThe expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels
2013-06-21Myoscience IncThe outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caut

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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.