Abeon Medical Corporation
Brecksville, OH, US
Abeon Medical Corporation appears in FDA device records in Brecksville, OH. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Abeon Medical Corporation in 2014.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 2 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0686-2016 | Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure. | The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. | Class II | Terminated | |
| Z-0685-2016 | TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure. | The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. | Class II | Terminated | |
| Z-0684-2016 | TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface. | The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain