10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
KELLER CEPHALOMETRIC DEVICE
FDA 510(k)
FDA Class 1
·Radiology
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690122678·Modular Stem 19mm x 75mm
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209100255·KIT, RESUPPLY w' COMBAT GAUZE
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Estremo Fibular Nail
FDA 510(k)
FDA Class 2
·Orthopedic
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 5, 2014
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·November 21, 2012
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·September 22, 2010
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Recall
Open, Classified
·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025