9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ONE STEP BUTTON(TM)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756356336·CIRCUMCISION PACK
UCR
FDA UDI
Seaspine Orthopedics Corporation·10889981080037·Solid Tap, 5.5mm
CAYMAN LP Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 11, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION·Product code HAW·November 19, 2010
MODULAR HANDLE
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·July 2, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021