9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESIMENT WITH FLUORIDE
FDA 510(k)
FDA Class 2
·Dental
COAXIAL VOL. VENTILATOR CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
ELITE IBF
FDA 510(k)
FDA Class 2
·Orthopedic
V18 CONTROL WIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP·Product code DQX·March 16, 2007
V18 CONTROL WIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·May 23, 2007
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 20, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 29, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 14, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024