7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
IONODENT (TOOTHBRUSH)
FDA 510(k)
FDA Class 1
·Dental
ROTAVIRUS BIO-ENZABEAD SCREEN KIT
FDA 510(k)
FDA Class 1
·Microbiology
O'NEIL URINARY CATHETER INTRODUCER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 16, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·October 12, 2010
UNK-HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·December 14, 2012
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024