10,000 results
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49ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Smart Caregiver
FDA UDI
Smart Caregiver Corporation·00812293013939·Cordless Pressure-Sensing Fall Mattress
ViperWire
FDA UDI
Cardiovascular Systems, Inc.·10852528005701·Guidewire, Viperwire Advance Coronary Flex Tip ...
ViperWire
FDA UDI
Cardiovascular Systems, Inc.·10852528005183·Guidewire, Viperwire Adavnce Coronary Floppy, ....
DIAMONDBACK CORONARY
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC.·Product code MCX·March 26, 2019
DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
FDA Adverse Event
Malfunction
·CARDIOVASCULAR SYSTEMS, INC.·Product code MCW·October 26, 2020
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
FDA Enforcement
Class II
·Ongoing·Noah Medical·May 8, 2024
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
FDA Adverse Event
Malfunction
·CARDIOVASCULAR SYSTEMS, INC.·Product code MCX·July 24, 2020
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC·Product code MCX·May 1, 2024
DIAMONDBACK CORONARY
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC.·Product code MCX·September 18, 2024
DIAMONDBACK CORONARY
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC. (ABBOTT)·Product code MCX·August 29, 2024
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC. (ABBOTT)·Product code MCX·June 7, 2024
DIAMONDBACK CORONARY
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC.·Product code MCX·October 25, 2024
EVOLUT FX VALVE
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·October 25, 2024
DIAMONDBACK CORONARY (VIPERWIRE, ADVANCE)
FDA Adverse Event
Death
·CARDIOVASCULAR SYSTEMS, INC. (ABBOTT)·Product code MCX·July 24, 2024
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC.·Product code MCX·July 15, 2024
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC.·Product code MCX·July 10, 2024
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC.·Product code MCX·April 16, 2024
DIAMONDBACK CORONARY
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC.·Product code MCX·October 10, 2024
DIAMONDBACK CORONARY
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC. (ABBOTT)·Product code MCX·October 25, 2024
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 10, 2023