11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645
FDA 510(k)
FDA Class 2
·Radiology
RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERSAFITCUP CC TRIO CUP 54
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·January 14, 2013
M2A-MAGNUM 42-50 TPR INSRT STD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
ENRHYTHM DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·June 14, 2011
Ureteral dilator, REF RBD014
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 10, 2024
PLATE ADAPTER DIST. LAT. FEMUR RIGHT
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HWC·May 11, 2017
COBAS E411 RACK SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·August 15, 2011
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHI·August 15, 2011