17 results
·
29ms
·
Sources: EU EUDAMED, US FDA
ML DISPOSABLE ALK TUBING
FDA 510(k)
FDA Class 1
·Ophthalmic
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292879·
RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
FDA 510(k)
FDA Class 2
·Neurology
OrthoPediatrics Titanium PediPlates® System
FDA 510(k)
FDA Class 2
·Orthopedic
BD ALARIS¿ SMARTSITE¿ GRAVITY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·February 9, 2023
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCO·Product code CBK·February 1, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 26, 2011
BIODESIGN TENSION-FREE URETHRAL SLING
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code PAG·July 8, 2014
AIA-900
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·February 24, 2016
TOSOH AIA-900
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·December 13, 2016
BD GEM V/NV 20D 0.2 FLTR
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·July 28, 2022
A1A-600II
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·October 28, 2016
TOSOH AIA-1800
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·November 11, 2016
AIA-360
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·March 3, 2016
GEM V/NV NTG 20DP 20PK
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 10, 2020
BD ALARIS¿ SMARTSITE¿ GRAVITY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·January 20, 2023
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020