8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BEECH VERSA LOK
FDA 510(k)
FDA Class 2
·General Hospital
Ventura NanoMetalene System
FDA UDI
Seaspine Orthopedics Corporation·10889981152031·Ventura NM Trial, 9mm x 28mm x 10mm, Lordotic
Revolution Ascend Sliding
FDA 510(k)
FDA Class 2
·Radiology
TITANIUM CANNULATED INTERFERENCE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·December 16, 2010
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·January 29, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 15, 2014
Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017