16 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ICON (TM) MODULAR PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089448814·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213032767·Coupling Treatment Tube for Metal Needles (8)
OPUS SPEEDSCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES SCOUT TACK FIXATION
FDA 510(k)
FDA Class 2
·Cardiovascular
VERSYS FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LPH·February 25, 2016
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 14, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTL, LTD.·Product code KWA·May 13, 2011
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
ACHIEVE MAPPING CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRF·November 14, 2019
FLEXCATH ADVANCE STEERABLE SHEATH
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRA·November 14, 2019
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025