8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STABLELOC II EXTERNAL FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
Nexxis OR
FDA UDI
Barco NV·05415334034891·NEXXIS SYSTEM X670 CM V4
CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
FDA 510(k)
FDA Class 2
·General Hospital
MODEL 2001, MODIFICATION
FDA 510(k)
FDA Class 2
·General Hospital
DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
FDA Adverse Event
Malfunction
·MPRI·Product code NVY·February 15, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011
SYSTEM 6 ASEPTIC HOUSING ASSY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·July 29, 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