14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTICUL/EZE Ceramic Heads
FDA 510(k)
FDA Class 2
·Orthopedic
HEALIX ADVANCE ORTHOCORD
FDA UDI
Medos International Sàrl·10886705021321·HEALIX ADVANCE BR 3 SUTURE ANCHOR w/ORTHOCORD T...
Sonic
FDA UDI
Sonic Innovations, Inc.·05714464010783·SONIC RADIANT 100 MNR T R BL
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
FDA 510(k)
FDA Class 2
·Orthopedic
VERSATAP SUTURE ANCHOR
FDA Adverse Event
Malfunction
·ORTHO-DESIGN·Product code MBI·September 15, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·March 21, 2024
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·March 21, 2024
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·November 3, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
12/14 ARTICUL 40MM M SPEC+1.5
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code LPH·July 12, 2013
4.75 HEALIX ADVANCE KNTLSS BR
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·April 24, 2018
4.5 HEALIX ADVANCE BR3SUT W/OC
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·April 24, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025