184 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
FDA 510(k)
FDA Class 2
·Neurology
IMPACT-20
FDA UDI
Denplus Inc·D8451031303·IMPACT-20, RPI, 11.3 kg
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310030·Probe, 1.5 inch Ball, Steffee, Curved, Black
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0315030·Probe, 1.5 inch Ball, Steffee, Curved, Impaction
BREAST IMMOBILIZATION DEVICE MR-BY 160
FDA 510(k)
FDA Class 2
·Radiology
RANDOX PHENOBARBITAL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 5, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC·Product code JAA·March 16, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Malfunction
·BIOENTERICS CORP.·Product code LTI·April 17, 2008
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 5, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 8, 2018