7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
SHILEY PRESSURE RELIEF ADAPTER PRA
FDA 510(k)
FDA Class 2
·Anesthesiology
PROGENIX DMB PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·February 21, 2013
OPTETRAK LOGIC
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·January 20, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026