8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOENNIES NEUROSCREEN SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Gafchromic™
FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00850000065857·Blood Irradiation Indicator
Velofix TLIF Cage
FDA 510(k)
FDA Class 2
·Orthopedic
ADVANTIV SAFETY I.V. CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
TI TRANSCONNECTOR 60MM
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code KWP·February 15, 2013
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·January 24, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 31, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021