10 results
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35ms
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Sources: EU EUDAMED, US FDA
RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY
FDA 510(k)
FDA Class 2
·Ophthalmic
Everyway OTC TENS/EMS Combination
FDA 510(k)
FDA Class 2
·Neurology
THERMOTEX PLATINUM SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 7, 2013
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·February 15, 2011
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014
GORE® DUALMESH® BIOMATERIAL
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code FTL·November 12, 2020
GORE® DUALMESH® BIOMATERIAL
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code FTL·November 12, 2020
COD.712 TOP CIRC.RACC.CARDIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTN·December 15, 2011
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026