Mira, Inc.

Uxbridge, MA, US

MIRA, INC. appears in FDA device records in Uxbridge, MA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 3 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 3
Registered establishments: 1

510(k) clearance history

FDA records hold 1 510(k) clearance for Mira, Inc. in 1996.

Clearances by year, as a table

510(k) clearance decisions for Mira, Inc., by decision year
Year	Clearances
1996	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K950806	SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS	HQX	Substantially Equivalent	1996-06-05

Registered establishments

FDA registered establishments for Mira, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1218813	1218813	MIRA, INC.	414 Quaker Hwy, UXBRIDGE, MA 01569 US	2026	GEH HPS HQJ HQX

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Initiated	Status
Z-1920-2010	MIRA CR4060 68 mm Finger Probe 68mm surf ace x 37mm Length Intended for the destruction of tumors.	Devices distributed without an approved 510(k)	2010-04-08	Terminated
Z-1919-2010	MIRA CR4055 25mm Finger Probe 25mm surface x 30mm Length Intended for the destruction of tumors.	Devices distributed without an approved 510(k)	2010-04-08	Terminated
Z-1918-2010	MIRA CR4050 12mm Finger Probe 12mm surface x 27mm Length Intended for the destruction of tumors.	Devices distributed without an approved 510(k)	2010-04-08	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain