Data / Medical devices / United States / Acme-Monaco Corp.
Acme-Monaco Corp.: FDA-registered device maker in New Britain, CT, United States, 2 510(k) clearances
Acme-Monaco Corp. is registered with the FDA (registration 1293141) in New Britain, CT, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 20, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1293141
- Address
- 75 Winchell Rd, New Britain, CT, United States, 06052
- Owner or operator
- ACME-MONACO CORP. (1293141)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 6, 1992
- Registered through
- 2026
- Brand names listed
- Acme Monaco Slidewire, Guidewire, 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 |
| Guide, Surgical, Instrument | FZX | 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 |
| Tubes, Gastrointestinal (And Accessories) | KNT | 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 |
|---|---|---|---|---|---|---|
| July 20, 2012 | K113162 | SLIDEWIRETM(TRADEMARK PENDING) | DQX | Substantially Equivalent | Acme-Monaco Corp. | accessdata.fda.gov |
| August 19, 1992 | K920884 | GUIDEWIRES, VARIOUS TYPES | DQX | Substantially Equivalent | Acme-Monaco Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Orthodontic
- All makers of Guide, Surgical, Instrument
- All makers of Bracket, Metal, Orthodontic
- All makers of Wire, Guide, Catheter
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Spring, Orthodontic
Updated July 20, 2012. 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.