23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAGNETOM Sola
FDA 510(k)
FDA Class 2
·Radiology
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414659061·Automatic Disposable Biopsy Needle
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414659252·Automatic Disposable Biopsy Needle
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414659191·Automatic Disposable Biopsy Needle
CoRoent
FDA UDI
Nuvasive, Inc.·00887517638885·CoRoent Ant TLIF PEEK, 8x11x32mm 12°
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL
FDA 510(k)
FDA Class 2
·Radiology
JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001
FDA 510(k)
FDA Class 2
·General Hospital
OSSURE LOEP KIT
FDA Adverse Event
Death
·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018
OSSURE LOEP KIT
FDA Adverse Event
Death
·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
PERIGEE
FDA Adverse Event
Injury
·AMERICAN MEDICLA SYSTEMS, INC.·Product code FTL·July 21, 2011
ASSY, HEADBAND ULTRALITE 2 BIF
FDA Adverse Event
Injury
·INTEGRA BURLINGTON, MA, INC.·Product code FCW·June 14, 2013
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·November 20, 2017
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·December 19, 2017
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 8, 2019
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 22, 2019
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 29, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·January 26, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·February 12, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 29, 2018