15 results
·
26ms
·
Sources: EU EUDAMED, US FDA
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983071·posteriors; shade B4; size S; lower jaw
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018
VLIFT-s Vertebral Body Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
VERTEX RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ARCHITECT CREATINE KINASE
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018
ARCHITECT CREATINE KINASE
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018
ARCHITECT CREATINE KINASE
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 22, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 14, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 5, 2018
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·HEARTWARE, INC·Product code DSQ·February 28, 2013
ITREL 3
FDA Adverse Event
Injury
·MEDTRONIC EUROPE SARL·Product code LGW·February 4, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 6, 2014
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024