8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
HANDLER CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515199613·Bone Hook, 11mm h x 22mm depth, medium, 9"
CHIN IMPLANTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EZ PLUS IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 18, 2014
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 25, 2007
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·October 3, 2012
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017