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AMBLER SURGICAL CORP. · Model Elliot corneal trephine · UDI-DI 00190660192136
HRH
Prescription
10
510(k) clearances
23
Adverse events
1
Recalls
122
Facilities
Description
Elliot corneal trephine, set includes handle, 2 each 1.5mm and 2.0mm diameter blades (7451E, 7453E x2 and 7454E x2)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
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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.