Data / Medical devices / United States / Acme-Monaco Corp.
Acme-Monaco Corp.: FDA-registered device maker in Presque Isle, ME, United States, 1 510(k) clearance
Acme-Monaco Corp. is registered with the FDA (registration 1222301) in Presque Isle, ME, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 19, 1992. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1222301
- FEI number
- 1000121071
- Address
- 1450 Central Drive, Presque Isle, ME, United States, 04769
- Owner or operator
- ACME-MONACO CORP. (1293141)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 6, 1992
- Registered through
- 2026
- Brand names listed
- MULTIPLE PRODUCTS, Multiple
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bracket, Metal, Orthodontic | EJF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Stylet, Catheter | DRB | 2 | Contract manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 19, 1992 | K920884 | GUIDEWIRES, VARIOUS TYPES | DQX | Substantially Equivalent | Acme-Monaco Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Clamp, Wire, Orthodontic
- All makers of Wire, Guide, Catheter
- All makers of Spring, Orthodontic
- All makers of Stylet, Catheter
- All makers of Wire, Orthodontic
- All makers of Bracket, Metal, Orthodontic
Updated August 19, 1992. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.