21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ICS Impulse
FDA 510(k)
FDA Class 2
·Neurology
DRIVEMEDICAL
FDA UDI
Drive Devilbiss Healthcare·00822383528533·Pressure PreventionSeat and Back Cushions Produ...
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837088361·
BD MAX¿ CDIFF
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OZN·March 14, 2023
SPYSCOPE ACCESS AND DELIVERY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TI-CORE FLOW
FDA 510(k)
FDA Class 2
·Dental
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code MPB·December 19, 2016
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 7, 2013
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·June 24, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·August 1, 2018
COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET
FDA Adverse Event
Injury
·COOK INC·Product code MPB·June 13, 2017
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·January 14, 2020
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·January 14, 2020
COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET
FDA Adverse Event
Injury
·COOK INC·Product code MPB·March 19, 2018
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·June 7, 2018
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·July 11, 2019
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013