11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRAVIOLET LIGHT PROTECTVE EYEWERE
FDA 510(k)
FDA Class 1
·Ophthalmic
48CH Head Coil
FDA 510(k)
FDA Class 2
·Radiology
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
FDA 510(k)
FDA Class 2
·Neurology
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·January 24, 2013
PINNACLE SECTOR II CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·January 24, 2013
12/14 ARTICUL 40MM M SPEC+1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·January 24, 2013
LIGASURE ADVANCE PISTOL GRIP
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·May 28, 2014
ENDOPATH** XCEL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·October 25, 2010
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·December 19, 2012
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017