13 results
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32ms
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Sources: EU EUDAMED, US FDA
PARAMAX AMMONIA REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DESS dental smart solutions
FDA UDI
TERRATS MEDICAL SL.·08435457233411·Tri-lobe
ULTRASONIC DIAGNOSTIC TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
Uroview FD II
FDA 510(k)
FDA Class 2
·Radiology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2024
ELLIPSE VR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 25, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code IOR·December 19, 2012
OXFORD UNI FEMORAL MD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·March 4, 2025
OXF UNI TIB TRAY SZ C RM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·March 4, 2025
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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