19 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SPLITSCREEN (ME-975)
FDA 510(k)
FDA Class 1
·Radiology
NA
FDA UDI
KEY SURGICAL, INC.·10849771049101·K-Wires, Single trocar, .062-inch (1.6mm) diame...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292763·
K-Wire w. trocar/round end 1.57mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM711530·K-Wire w. trocar/round end
1.57mm...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484306·K-Wire w. trocar/round end _x000D_...
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DYNA ZYME II GOT 340
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·April 29, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCO·Product code CBK·February 1, 2013
KINAIR MEDSURG PULSE
FDA Adverse Event
Death
·KCI-USA, INC·Product code IOQ·January 14, 2011
AIA-900
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·February 24, 2016
PLEURX DRAINAGE KIT 500ML 10/CS
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·July 25, 2025
TOSOH AIA-900
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·December 13, 2016
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
PLEURX DRAINAGE KIT 500ML 10/CS
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·December 24, 2024
PLEURX DRAINAGE KIT 500ML 10/CS
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·December 24, 2024
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017