7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
JACKSON ESOPHAGEAL DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MINIME PEDIATRIC MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
EZER, Portable X-ray System
FDA 510(k)
FDA Class 2
·Dental
OT VITA ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 6, 2013
OPEN-END FLEXI-TIP URETERAL CATHETER
FDA Adverse Event
Injury
·COOK UROLOGICAL INC·Product code GBL·February 10, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021