8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT
FDA 510(k)
FDA Class 1
·Microbiology
Sasmar Strawberry
FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008242·PERSONAL LUBRICANT
BIO-CONSOLE 560
FDA 510(k)
FDA Class 2
·Cardiovascular
VaPro 2 Intermittent Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 29, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
*
FDA Adverse Event
Malfunction
·NXSTAGE MEDICAL, INC.·Product code KDI·November 14, 2012
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025