27 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXPEDIUM ANTERIOR SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7403041205·12mm x 50mm Portal Tube
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112050·Tap, 7.5 mm
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
9616026-2006-00240
FDA Adverse Event
Malfunction
·Product code FII·June 21, 2006
9616026-2006-00244
FDA Adverse Event
Malfunction
·Product code FII·June 22, 2006
9616026-2006-00239
FDA Adverse Event
Malfunction
·Product code FII·June 22, 2006
9616026-2006-00222
FDA Adverse Event
Malfunction
·Product code FII·June 21, 2006
PRISMAFLEX SYSTEM
FDA Adverse Event
Malfunction
·GAMBRO LUNDIA AB, MONITOR DIVISION·Product code MQS·June 8, 2006
PRISMAFLEX SYSTEM
FDA Adverse Event
Malfunction
·GAMBRO LUNDIA AB, MONITOR DIVISION·Product code MQS·June 8, 2006
PRISMAFLEX SYSTEM
FDA Adverse Event
Malfunction
·GAMBRO LUNDIA AB, MONITOR DIVISION·Product code MQS·June 8, 2006
9616026-2006-00252
FDA Adverse Event
Other
·Product code FII·June 21, 2006
9616026-2006-00245
FDA Adverse Event
Malfunction
·Product code FII·June 22, 2006
9616026-2006-00253
FDA Adverse Event
Other
·Product code FII·June 21, 2006
PRISMAFLEX SYSTEM
FDA Adverse Event
Malfunction
·GAMBRO LUNDIA AB, MONITOR DIVISION·Product code MQS·June 8, 2006
9616026-2006-00221
FDA Adverse Event
Malfunction
·Product code FII·June 21, 2006
PRISMAFLEX SETS (M)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDI·May 13, 2024
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·May 20, 2025
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 8, 2013