20 results · 23ms · Sources: EU EUDAMED, US FDA

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LOGIQ E10

FDA 510(k)
FDA Class 2 ·Radiology

PIVOX™ Oblique Lateral Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169600133·TRIAL 2173555 O25 IB 20MM 18 DEG 16X55

PIVOX™ Oblique Lateral Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000878528·TRIAL 2173555 O25 IB 20MM 18 DEG 16X55

Sklar®

FDA UDI
SKLAR CORPORATION·10649111101311·COLLER FCP CVD 5 1/2"

INSULIN PROTECTOR

FDA 510(k)
FDA Class 1 ·Physical Medicine

MULTIPLATE 5.0 AGGREGOMETER

FDA 510(k)
FDA Class 2 ·Hematology

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·May 18, 2026

KANGAROO

FDA Adverse Event
Injury ·CARDINAL HEALTH 200, LLC·Product code KNT·April 6, 2026

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·April 17, 2026

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·May 1, 2026

HILL-ROM 1000 BED

FDA Adverse Event
Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·June 5, 2013

ACCU-CHEK ® COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 23, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·February 5, 2026

LUCAS 3 CHEST COMPRESSION SYSTEM

FDA Adverse Event
Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·December 30, 2024

LUCAS 3 CHEST COMPRESSION SYSTEM

FDA Adverse Event
Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·November 25, 2025

FUSION ENT NAVIGATION SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·February 2, 2021

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018