Macan Genesis Manufacturing LLC
Elmwood, WI, US
MACAN GENESIS MANUFACTURING LLC appears in FDA device records in Elmwood, WI. 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
FDA records under these names
1 nameFDA records resolved to Macan Genesis Manufacturing LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Macan Engineering and Manufacturing Co., Inc.recall
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 |
|---|---|---|---|---|---|
| 1418975 | 1418975 | MACAN GENESIS MANUFACTURING LLC | 200 N Main St, Elmwood, WI 54740 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-0810-06 | Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA (773) 772-2000 | The product label fails to warn users to use the device on patients with shielded pacemakers only. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain