16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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