Company ยท US
Mira, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1997. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HPS | Unit, Cryophthalmic | 4 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 4 |
| HQF | Laser, Ophthalmic | 4 |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 1 |
| FRN | Pump, Infusion | 1 |
| HLI | Ophthalmoscope, Ac-Powered | 1 |
| HNR | Forceps, Ophthalmic | 1 |
| HPO | Magnet, Ac-Powered | 1 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | 1 |
| HQT | Shell, Scleral | 1 |
| HQX | Implant, Orbital, Extra-Ocular | 1 |
| HWA | Impactor | 1 |
| LCR | Fluorescent Immunoassay, Tobramycin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 19, 1997 | K951728 | SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE Mira, Inc. | HLI |
| Jun 5, 1996 | K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS Mira, Inc. | HQX |
| Jul 15, 1994 | K941495 | RETURN PATH DIATHERMY HANDLE Mira, Inc. | HQR |
| Jan 25, 1994 | K933527 | MODIFICATION OF ANTERIOR SEGMENT ELECTRODES Mira, Inc. | HWA |
| Oct 19, 1992 | K923629 | OPHTHALMIC TRICHIASIS PROBE Mira, Inc. | HPS |
| Feb 27, 1990 | K894248 | CONVERTER SYSTEM Mira, Inc. | HQE |
| May 23, 1989 | K891601 | POWER OPERATED AND CONTROLLED VITREOUS SCISSORS Mira, Inc. | HQE |
| May 8, 1989 | K890448 | LIGHT SOURCE, ENDOSCOP, XENON ARC Mira, Inc. | FFS |
| Oct 31, 1986 | K863246 | MIRALITE Mira, Inc. | HQF |
| Oct 10, 1986 | K863591 | ENDOPHOTOCOAGULATION PROBE Mira, Inc. | HQF |
| Mar 31, 1986 | K855105 | SIMMONS SHELL Mira, Inc. | HQT |
| Mar 5, 1986 | K854869 | INTRAOCULAR FORCEPS & SCISSORS Mira, Inc. | HNR |
| Feb 27, 1986 | K855215 | AIR/FLUID EXCHANGE SYSTEM Mira, Inc. | FRN |
| Feb 19, 1986 | K854870 | INTRAOCULAR ELECTROMAGNET Mira, Inc. | HPO |
| Feb 13, 1986 | K854872 | VFI/VFE SYSTEM II Mira, Inc. | |
| Feb 7, 1986 | K854871 | MICRO SURGICAL SYSTEM Mira, Inc. | HQE |
| Feb 7, 1986 | K854868 | I/A - VFE SYSTEM II Mira, Inc. | HQE |
| Feb 4, 1986 | K854873 | INTRAOCULAR PRESSURE REDUCER Mira, Inc. | LCR |
| Nov 12, 1985 | K854288 | OPHALMIC LASER PHOTOCOAGULATOR Mira, Inc. | HQF |
| Nov 12, 1985 | K853890 | OPHTHALMIC LASER PHOTOCOAGULATOR Mira, Inc. | HQF |
| Nov 6, 1984 | K843345 | AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON Mira, Inc. |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2010 | Mira, Inc. MIRA CR4060 68 mm Finger Probe
68mm surf ace x 37mm Length
Intended for the destruction of tumors. Terminated |
HPS | None listed |
| Jun 29, 2010 | Mira, Inc. MIRA CR4055 25mm Finger Probe
25mm surface x 30mm Length
Intended for the destruction of tumors. Terminated |
HPS | None listed |
| Jun 29, 2010 | Mira, Inc. MIRA CR4050 12mm Finger Probe
12mm surface x 27mm Length
Intended for the destruction of tumors. Terminated |
HPS | None listed |