11 results
·
17ms
·
Sources: EU EUDAMED, US FDA
LASER-LYSE
FDA 510(k)
FDA Class 1
·Hematology
n/a
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000280529·LID 1850097 GENERIC OUTER LID
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111573·Modular Stem 9mm x 75mm
GM60A-32S & GM60A-40S
FDA 510(k)
FDA Class 2
·Radiology
TECHNO-SCOPE VISUAL STETHOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2014
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 26, 2012
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·September 28, 2010
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Recall
Open, Classified
·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021