10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
FDA 510(k)
FDA Class 2
·Neurology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694035569·CalFix, Locking Calcaneal Plate, 56mm
K2M General Instruments
FDA UDI
VB Spine LLC·10888857581517·Split Tube Retractor Ø26x80 mm
SNAP-OFF SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 4, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ENDO STITCH
FDA Adverse Event
Malfunction
·COVIDIEN·Product code OCW·June 21, 2011
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 11, 2016
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017