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Myo/Wire II
A & E MEDICAL CORPORATION · Model 045-006 · UDI-DI 10841291102403
1
510(k) clearances
601
Adverse events (10 deaths)
1
Recalls
18
Facilities
Description
SS Suture, 6 per sleeve
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-02-11 | EXP Pharmaceutical Services Corp | EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re |
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Get your free API keyRead the docsData 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.