Medical Device Manufacturer · US , Waltham , MA

Mira, Inc.

21 submissions · 21 cleared · Since 1984
21
Total
21
Cleared
0
Denied

Mira, Inc. — FDA 510(k) Submissions

Mira, Inc. has submitted 21 FDA 510(k) premarket notifications since 1984, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Laser, Ophthalmic, Instrument, Vitreous Aspiration And Cutting, Ac-powered, Fluorescent Immunoassay, Tobramycin, Shell, Scleral, Pump, Infusion . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE
K951728 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Mar 1997 706d
SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
K950806 · HQX Implant, Orbital,... · Ophthalmic
Jun 1996 469d
RETURN PATH DIATHERMY HANDLE
K941495 · HQR Apparatus, Cautery,... · Ophthalmic
Jul 1994 109d
MODIFICATION OF ANTERIOR SEGMENT ELECTRODES
K933527 · HWA Impactor · Orthopedic
Jan 1994 189d
OPHTHALMIC TRICHIASIS PROBE
K923629 · HPS Unit, Cryophthalmic · Ophthalmic
Oct 1992 90d
CONVERTER SYSTEM
K894248 · HQE Instrument, Vitreous... · Ophthalmic
Feb 1990 251d
POWER OPERATED AND CONTROLLED VITREOUS SCISSORS
K891601 · HQE Instrument, Vitreous... · Ophthalmic
May 1989 64d
LIGHT SOURCE, ENDOSCOP, XENON ARC
K890448 · FFS Image, Illumination,... · Gastroenterology & Urology
May 1989 101d
MIRALITE
K863246 · HQF Laser, Ophthalmic · Ophthalmic
Oct 1986 70d
ENDOPHOTOCOAGULATION PROBE
K863591 · HQF Laser, Ophthalmic · Ophthalmic
Oct 1986 25d
SIMMONS SHELL
K855105 · HQT Shell, Scleral · Ophthalmic
Mar 1986 98d
INTRAOCULAR FORCEPS & SCISSORS
K854869 · HNR Forceps, Ophthalmic · Ophthalmic
Mar 1986 91d
AIR/FLUID EXCHANGE SYSTEM
K855215 · FRN Pump, Infusion · General Hospital
Feb 1986 59d
INTRAOCULAR ELECTROMAGNET
K854870 · HPO Magnet, Ac-powered · Ophthalmic
Feb 1986 77d
VFI/VFE SYSTEM II
K854872 · Ophthalmic
Feb 1986 71d
I/A - VFE SYSTEM II
K854868 · HQE Instrument, Vitreous... · Ophthalmic
Feb 1986 65d
MICRO SURGICAL SYSTEM
K854871 · HQE Instrument, Vitreous... · Ophthalmic
Feb 1986 65d
INTRAOCULAR PRESSURE REDUCER
K854873 · LCR Fluorescent Immunoassay,... · Toxicology
Feb 1986 62d
OPHTHALMIC LASER PHOTOCOAGULATOR
K853890 · HQF Laser, Ophthalmic · Ophthalmic
Nov 1985 54d
OPHALMIC LASER PHOTOCOAGULATOR
K854288 · HQF Laser, Ophthalmic · Ophthalmic
Nov 1985 18d
AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON
K843345 · Ophthalmic
Nov 1984 71d
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