8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
AQUAVALVE
FDA 510(k)
FDA Class 1
·Anesthesiology
WIRE TWISTERS
FDA 510(k)BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL
FDA 510(k)
FDA Class 1
·Physical Medicine
PROMUS ELEMENT? PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 10, 2014
IROX
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code NVN·October 11, 2010
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 10, 2012
GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015