8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KINEMATIC ROTATING HINGE TOTAL KNEE PR.
FDA 510(k)
FDA Class 2
·Orthopedic
A-FIT®
FDA UDI
Gc Orthodontics America Inc.·E53581163000001·A-FIT® 1. MOLAR UPR RGT SZ 30
Revolution External Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2014
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·October 31, 2012
9XT SWINGAWAY FRAME STYLE 9153629153
FDA Adverse Event
Injury
·INVAMEX·Product code IOR·June 2, 2015
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018