Medical Device Manufacturer · US , Waltham , MA

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

21 submissions · 21 cleared · Since 1984

Total

Cleared

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

1-12 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

POWER OPERATED AND CONTROLLED VITREOUS SCISSORS

K891601 · HQE

Ophthalmic · 64d

Cleared May 08, 1989

LIGHT SOURCE, ENDOSCOP, XENON ARC

K890448 · FFS

Gastroenterology & Urology · 101d

ENDOPHOTOCOAGULATION PROBE

INTRAOCULAR FORCEPS & SCISSORS

K854869 · HNR

Ophthalmic · 91d

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

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