Acme-Monaco Corp.
Presque Isle, ME, US
ACME-MONACO CORP. appears in FDA device records in Presque Isle, ME. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Acme-Monaco Corp. between 1988 and 2012. The busiest year on record is 1990, with 2. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1990 | 2 |
| 1992 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K113162 | SLIDEWIRETM(TRADEMARK PENDING) | DQX | Substantially Equivalent | |
| K920884 | GUIDEWIRES, VARIOUS TYPES | DQX | Substantially Equivalent | |
| K895854 | ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE) | EJF | Substantially Equivalent | |
| K895483 | ACME COATED ORTHODONTIC ARCHWIRE | EJF | Substantially Equivalent | |
| K883763 | ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH | KOD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1222301 | 1000121071 | ACME-MONACO CORP. | 1450 Central Drive, PRESQUE ISLE, ME 04769 US | 2026 | |
| 1293141 | 1293141 | ACME-MONACO CORP. | 75 Winchell Rd, NEW BRITAIN, CT 06052 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain