Pemco Inc
Cleveland, OH, US
PEMCO, INC. appears in FDA device records in Cleveland, OH. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1519227 | 1519227 | PEMCO, INC. | 5663 BRECKSVILLE RD., Cleveland, OH 44131 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1783-2013 | Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site | The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain