7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT
FDA 510(k)
FDA Class 2
·Dental
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
FDA 510(k)
FDA Class 2
·Medical Genetics
HD15 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 18, 2014
ENDOPATH** XCEL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·October 25, 2010
R3
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·December 20, 2012
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024