11 results
·
36ms
·
Sources: EU EUDAMED, US FDA
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205004253·Luna Opal R Mini .022 UR3 (0°T +11°A)
NA
FDA UDI
Synthes GmbH·10886982156303·1.3MM STRAIGHT PLATE 6 HOLES
VECTORVISION CT-FREE KNEE
FDA 510(k)
FDA Class 2
·Neurology
SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HAMILTON-C3
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 9, 2024
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
7200
FDA Adverse Event
Malfunction
·COVIDIEN PURITAN-BENNETT·Product code CBK·August 16, 2011
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NKM·April 1, 2024
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025