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MIRA, INC.

Last updated September 17, 2026

Information

Country: US
Address: 414 Quaker Hwy, UXBRIDGE, MA, 01569
Website: mirainc.us
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 5082787877
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1218813
DUNS Number: 001414358

Catalogue (81)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
MIRA IMEX Scleral Buckling Component	511	FDA UDI	Class II	Active
MIRA IMEX Scleral Buckling Component	278	FDA UDI	Class II	Active
MIRA IMEX Scleral Buckling Component	70	FDA UDI	Class II	Active
MIRA Gragoudas Ring	175	FDA UDI	Class II	Active
MIRA IMEX Scleral Buckling Component	519G	FDA UDI	Class II	Active
MIRA IMEX Scleral Buckling Component	510	FDA UDI	Class II	Active
MIRA IMEX Scleral Buckling Component	20	FDA UDI	Class II	Active
MIRA Cryosurgical Probe, Straight Retinal	CR4015	FDA UDI	Class II	Active
MIRA IMEX Scleral Buckling Component	279	FDA UDI	Class II	Active
MIRA IMEX Scleral Buckling Component	50	FDA UDI	Class II	Active
Modification Of Anterior Segment Electrodes	K933527	FDA 510(k)	Class I	Active
Ophalmic Laser Photocoagulator	K854288	FDA 510(k)	Class II	Active
Ophthalmic Laser Photocoagulator	K853890	FDA 510(k)	Class II	Active
Intraocular Pressure Reducer	K854873	FDA 510(k)	Class II	Active
Simmons Shell	K855105	FDA 510(k)	Class II	Active
Intraocular Forceps & Scissors	K854869	FDA 510(k)	Class I	Active
Vfi/Vfe System Ii	K854872	FDA 510(k)	N/A	Active
Air/Fluid Exchange System	K855215	FDA 510(k)	Class II	Active
Light Source, Endoscop, Xenon Arc	K890448	FDA 510(k)	Class II	Active
Intraocular Electromagnet	K854870	FDA 510(k)	Class II	Active
Miralite	K863246	FDA 510(k)	Class II	Active
Return Path Diathermy Handle	K941495	FDA 510(k)	Class II	Active
Solid Dilicone Implants, Sdilicone Sponge Implants	K950806	FDA 510(k)	Class II	Active
Converter System	K894248	FDA 510(k)	Class II	Active
Micro Surgical System	K854871	FDA 510(k)	Class II	Active
Agl400 Argon Laser System-Krl500 Krypton	K843345	FDA 510(k)	N/A	Active
Endophotocoagulation Probe	K863591	FDA 510(k)	Class II	Active
Ophthalmic Trichiasis Probe	K923629	FDA 510(k)	Class II	Active
I/A - Vfe System Ii	K854868	FDA 510(k)	Class II	Active
Power Operated And Controlled Vitreous Scissors	K891601	FDA 510(k)	Class II	Active
Schepens-Yoshida Video Binocular Indirect Ophthalmscope	K951728	FDA 510(k)	Class II	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 8, 2010	Z-1919-2010	—	terminated	Devices distributed without an approved 510(k)
Apr 8, 2010	Z-1920-2010	—	terminated	Devices distributed without an approved 510(k)
Apr 8, 2010	Z-1918-2010	—	terminated	Devices distributed without an approved 510(k)