209 results
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50ms
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Sources: EU EUDAMED, US FDA
MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the miraDry biotip and the miraDry Treatment Template system. Miramar Labs, Inc. 445 Indio Way Sunnyvale, CA 94085 Intended use: Treatment of primary axillary hyperhidrosis.
FDA Recall
Terminated
·Miramar Labs, Inc.·Product code OUB·April 24, 2011
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS, INC.·Product code OUB·November 16, 2016
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS, INC.·Product code OUB·October 6, 2016
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS, INC.·Product code OUB·November 17, 2016
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS INC.·Product code OUB·July 14, 2015
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS, INC.·Product code OUB·August 13, 2015
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS INC.·Product code OUB·July 22, 2015
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS INC.·Product code OUB·July 7, 2015
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS, INC.·Product code OUB·May 29, 2014
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS INC.·Product code OUB·May 2, 2014
MIRADRY SYSTEM
FDA Adverse Event
Malfunction
·MIRAMAR LABS, INC.·Product code OUB·September 2, 2015
MIRADRY SYSTEM
FDA Adverse Event
Malfunction
·MIRAMAR LABS, INC.·Product code OUB·September 2, 2015
MIRADRY SYSTEM
FDA Adverse Event
Malfunction
·MIRAMAR LABS, INC.·Product code OUB·September 2, 2015
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS, INC.·Product code OUB·August 20, 2015
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS, INC.·Product code OUB·September 1, 2015
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS, INC.·Product code OUB·July 29, 2015
MIRADRY SYSTEM
FDA Adverse Event
Malfunction
·MIRAMAR LABS, INC.·Product code OUB·September 2, 2015
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS, INC.·Product code OUB·July 20, 2015
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS, INC.·Product code OUB·August 19, 2015
MIRADRY SYSTEM
FDA Adverse Event
Injury
·MIRAMAR LABS INC.·Product code OUB·May 12, 2014