27 results
·
29ms
·
Sources: EU EUDAMED, US FDA
MY01 Inc.
Manufacturer
🇨🇦 Canada·2 Basic UDI-DIs·4 Devices·1 Importer·GMED SAS
MY01, INC.
FDA registration
MY01, INC.·1 product·🇨🇦 Canada
MY01 Mobile Application
FDA UDI
MY01 Inc·07540162030093·
MY01 Continuous Compartmental Pressure Monitor
FDA UDI
MY01 Inc·07540162030017·
MY01 Mobile Application
Device
EU MDR
·
Eu Md Class 2a
·MY01 Inc.·On the market·2 countries
MY01 Continuous Compartmental Pressure Monitor
Device
EU MDD
·
Eu Md Class 2a
·MY01 Inc.·On the market·1 country
MY01 Continuous Compartmental Pressure Monitor
Device
EU MDR
·
Eu Md Class 2a
·MY01 Inc.·No longer on the market·1 country
MY01 Mobile Application
Device
EU MDR
·
Eu Md Class 2a
·MY01 Inc.·On the market·2 countries
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
FDA Recall
Terminated
·Product code LXC·June 28, 2021
MY01 CONTINUOUS COMPARTMENTAL PRESSURE MONITOR
FDA Adverse Event
Injury
·MY01 INC.·Product code LXC·October 27, 2021
EASYPUMP 2
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code MEB·February 15, 2024
EASYPUMP 2
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code MEB·January 3, 2024
EASYPUMP 2
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code MEB·November 17, 2023
EASYPUMP 2
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code MEB·December 19, 2023
MY01 Continuous Compartmental Pressure Monitor
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·MY01 Inc.·1 device
MY01 Continuous Compartmental Pressure Monitor
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·MY01 Inc.·3 devices
EASYPUMP® II
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code MEB·October 19, 2016
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·October 18, 2023
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·August 29, 2023
EASYPUMP
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code MEB·August 14, 2023