8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VISCOUS FLUID SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Brigade
FDA UDI
Nuvasive, Inc.·00887517964977·Brigade Lateral, 14x34x24mm 8°
TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
THE FIAX 5000 FLUOROMETER
FDA 510(k)
FDA Class 1
·Immunology
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·February 15, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·January 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 29, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024