7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LUNA
FDA 510(k)
FDA Class 2
·Neurology
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181
FDA 510(k)
FDA Class 2
·Microbiology
NEPTUNE HYPERBARIC VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 28, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
SM104 M-SERIES W/5TH WHEEL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV.·Product code FPO·January 13, 2011
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024