27 results · 21ms · Sources: EU EUDAMED, 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