Data / Medical devices / United States / Mira, Inc.
Mira, Inc.: FDA-registered device maker in Uxbridge, MA, United States, 4 510(k) clearances
Mira, Inc. is registered with the FDA (registration 1218813) in Uxbridge, MA, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 5, 1996. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1218813
- Address
- 414 Quaker Hwy, Uxbridge, MA, United States, 01569
- Owner or operator
- MIRA, INC. (1218813)
- Roles
- Manufacturer
- First device listed
- November 3, 2007
- Registered through
- 2026
- Brand names listed
- CR4000, CR4010, CR4015, CR4022, CR4023, CR4025, CR4030, CR4040 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implant, Absorbable, (Scleral Buckling Methods) | HQJ | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Orbital, Extra-Ocular | HQX | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Cryophthalmic | HPS | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Cryosurgical, Accessories | GEH | 2 | 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 |
|---|---|---|---|---|---|---|
| June 5, 1996 | K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | HQX | Substantially Equivalent | Mira, Inc. | accessdata.fda.gov |
| October 19, 1992 | K923629 | OPHTHALMIC TRICHIASIS PROBE | HPS | Substantially Equivalent | Mira, Inc. | accessdata.fda.gov |
| November 1, 1976 | K760686 | CRYOLYZER ALPHA (CRYOSURG.EQUIP.) | GEH | Substantially Equivalent | Cryo-Labs, Inc. | accessdata.fda.gov |
| October 5, 1976 | K760550 | IMPLANT, SILICONE AND TANTALUM | HQJ | Substantially Equivalent | Medical Instrument Research Assoc., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 8, 2010 | 55818 | Not yet classified | Terminated | MIRA CR4050 12mm Finger Probe 12mm surface x 27mm Length Intended for the destruction of tumors. | Devices distributed without an approved 510(k) | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Cryosurgical, Accessories
- All makers of Implant, Orbital, Extra-Ocular
- All makers of Implant, Absorbable, (Scleral Buckling Methods)
Updated June 29, 2010. 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.