9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC
FDA 510(k)
FDA Class 1
·Physical Medicine
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123274·K-WIRE - DOUBLE TROCAR 1.8mm DIA x 150mm
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31
FDA 510(k)
FDA Class 2
·Radiology
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 ?11X440MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 20, 2012
PROMUS ELEMENT ¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·January 18, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·November 9, 2010
QUICK FLEX LV LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 9, 2014
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024