9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medusa Orthopedics Boa External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
BD¿ SYRINGE WITH BD LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 10, 2019
MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB
FDA 510(k)
FDA Class 2
·Cardiovascular
Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 25, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·November 26, 2015
MDA Simplastin L, Product number 252555, 10 vials, 40 ml ea (400 test each), bioMerieux Inc., Box 15969 Durham, North Carolina 27704-0969.
FDA Recall
Terminated
·bioMerieux·Product code GJS·July 31, 2003
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025