Medical Device Manufacturer · US , Waltham , MA

Mira, Inc. - FDA 510(k) Cleared Devices

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

Mira, Inc. has 21 FDA 510(k) cleared ophthalmic devices. Based in Waltham, US.

Historical record: 21 cleared submissions from 1984 to 1997.

Browse the complete list of FDA 510(k) cleared ophthalmic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Mira, Inc.
21 devices
1-21 of 21
Cleared Mar 19, 1997
SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE
K951728 · HLI
Ophthalmic · 706d
Cleared Jun 05, 1996
SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
K950806 · HQX
Ophthalmic · 469d
Cleared Jul 15, 1994
RETURN PATH DIATHERMY HANDLE
K941495 · HQR
Ophthalmic · 109d
Cleared Jan 25, 1994
MODIFICATION OF ANTERIOR SEGMENT ELECTRODES
K933527 · HWA
Orthopedic · 189d
Cleared Oct 19, 1992
OPHTHALMIC TRICHIASIS PROBE
K923629 · HPS
Ophthalmic · 90d
Cleared Feb 27, 1990
CONVERTER SYSTEM
K894248 · HQE
Ophthalmic · 251d
Cleared May 23, 1989
POWER OPERATED AND CONTROLLED VITREOUS SCISSORS
K891601 · HQE
Ophthalmic · 64d
Cleared May 08, 1989
LIGHT SOURCE, ENDOSCOP, XENON ARC
K890448 · FFS
Gastroenterology & Urology · 101d
Cleared Oct 31, 1986
MIRALITE
K863246 · HQF
Ophthalmic · 70d
Cleared Oct 10, 1986
ENDOPHOTOCOAGULATION PROBE
K863591 · HQF
Ophthalmic · 25d
Cleared Mar 31, 1986
SIMMONS SHELL
K855105 · HQT
Ophthalmic · 98d
Cleared Mar 05, 1986
INTRAOCULAR FORCEPS & SCISSORS
K854869 · HNR
Ophthalmic · 91d
Cleared Feb 27, 1986
AIR/FLUID EXCHANGE SYSTEM
K855215 · FRN
General Hospital · 59d
Cleared Feb 19, 1986
INTRAOCULAR ELECTROMAGNET
K854870 · HPO
Ophthalmic · 77d
Cleared Feb 13, 1986
VFI/VFE SYSTEM II
K854872
Ophthalmic · 71d
Cleared Feb 07, 1986
I/A - VFE SYSTEM II
K854868 · HQE
Ophthalmic · 65d
Cleared Feb 07, 1986
MICRO SURGICAL SYSTEM
K854871 · HQE
Ophthalmic · 65d
Cleared Feb 04, 1986
INTRAOCULAR PRESSURE REDUCER
K854873 · LCR
Toxicology · 62d
Cleared Nov 12, 1985
OPHTHALMIC LASER PHOTOCOAGULATOR
K853890 · HQF
Ophthalmic · 54d
Cleared Nov 12, 1985
OPHALMIC LASER PHOTOCOAGULATOR
K854288 · HQF
Ophthalmic · 18d
Cleared Nov 06, 1984
AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON
K843345
Ophthalmic · 71d
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