10 results
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26ms
·
Sources: EU EUDAMED, US FDA
0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX
FDA 510(k)
FDA Class 1
·Ophthalmic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123113·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 125mm
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 14, 2021
QT ECG
FDA 510(k)
FDA Class 2
·Cardiovascular
#4006 TSB-TUBED MEDIA
FDA 510(k)
FDA Class 1
·Microbiology
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·June 26, 2015
MAXIMO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·December 13, 2010
ACCENT DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
MEDFUSION 3500 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD·Product code FRN·December 19, 2012
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020