8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER
FDA 510(k)
FDA Class 2
·Orthopedic
ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MIS Internal Hex Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2014
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 22, 2010
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·December 19, 2012
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. 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