11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONGOOSE ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MONGOOSE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·TOGO MEDIKIT CO.LTD.·Product code DQO·December 15, 2017
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045982·Plateau-LO Spacer Caddy, 12 Degree
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 21, 2015
PSL ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
PRECISION? MONTAGE? MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 29, 2025
LC PCA REFURB 802.11
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·September 17, 2014
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·May 17, 2011
DELTEC
FDA Adverse Event
Malfunction
·SMITH MEDICAL·Product code FOZ·September 20, 2006
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025