37 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TERASON USMART3200T ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Oticon
FDA UDI
Oticon A/S·05707131255914·SENSEI, RITE 312 WL TC
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925018921·SHEA OVAL CUP,FINE,CVD UP
Trivicta
FDA UDI
Ortho Development Corporation·00822409123872·Collar EXT Size 9
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776318758·Wullstein Cup Forceps, Delicate
GE 1.5T 8 CHANNEL TORSO COIL
FDA 510(k)
FDA Class 2
·Radiology
INTEGRATED INNOVA - S5I SYSTEM OPTION
FDA 510(k)
FDA Class 2
·Radiology
COOK® CERVICAL RIPENING BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code PFJ·July 18, 2016
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 29, 2025
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 23, 2013
3 SERIES WRIST BLOOD PRESSURE MONITOR
FDA Adverse Event
Injury
·OMRON (DALIAN) CO., LTD (PLANT 1)·Product code DXN·September 9, 2014
PACEART SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DPS·June 16, 2011
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·February 19, 2026
COOK® CERVICAL RIPENING BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code PFJ·July 19, 2016
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·February 3, 2017
HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 10, 2019
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·March 10, 2017
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 10, 2017
INSPIRE 6F HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·August 3, 2022
INSPIRE 6 HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·February 25, 2022