9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Transpara
FDA 510(k)
FDA Class 2
·Radiology
MINI QA+ #0 ETH OS-2 *EA
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HWC·May 9, 2018
THORATEC PVAD
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 7, 2013
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·August 8, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 15, 2011
EQUINOXE PRIMARY SHOULDER COMPONENT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·October 5, 2022
IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830 This assay is intended for in vitro diagnostic use.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CFL·March 30, 2011