16 results · 22ms · Sources: EU EUDAMED, US FDA

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PEDIATRIC POSITIONER PAD SET

FDA 510(k)
FDA Class 1 ·Radiology

ZOLL PROPAQ M

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO CARDEON AEGIS CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 1, 2016

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 21, 2013

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 13, 2011

SYNOX SX 45 -JBP

FDA Adverse Event
Malfunction ·BIOTRONIK, GMBH AND CO.·Product code DTB·August 15, 2008

TPRLC 133 T1 PPS HO 10X140MM 0MM T1

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·June 25, 2020

TPRLC 133 MP TYPE1 PPS HO 16.0 M T1

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·June 25, 2020

TPRLC 133 T1 PPS HO 15X150MM 0MM T1

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·June 25, 2020

TPRLC XR T1 PPS 14X148MM MM T1

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·June 25, 2020

TPRLC 133 T1 PPS HO 14X148MM 8MM T1

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·June 25, 2020

TPRLC 133 MP T1 PPS SO 5X95MM

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·June 25, 2020

SOMATOM Edge Plus-Computed tomography system Model 1026700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

FDA Enforcement
Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017