10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LUCAS 3 Chest Compression System
FDA 510(k)
FDA Class 2
·Cardiovascular
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
MP-1 MICROPERIMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
MIE SCINTRON GAMMA CAMERA SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·August 5, 2017
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·July 8, 2011
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·June 6, 2013
HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICE.
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INC.·Product code FMJ·July 24, 2014
Philips Zenition 50, Model Number: 718096
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024