184 results · 36ms · Sources: EU EUDAMED, 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