11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SR-IVOTRAY SPECIAL
FDA 510(k)
FDA Class 1
·Dental
NA
FDA UDI
LANCER ORTHODONTICS, INC.·00817573023028·PASTE-FORMULA 3 .35g TIP 40/PK
EEG-Now
FDA 510(k)
FDA Class 2
·Neurology
Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GALAXY G3 MINI 2MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·March 16, 2021
WALKMED® 150 ML RESERVOIR BAG
FDA Adverse Event
Malfunction
·WALKMED TECHNOLOGIES, LLC·Product code FRN·September 5, 2025
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 31, 2012
MONOSYN VIOLET 4/0 (1.5) 8X45CM HR22TO (M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GAM·April 16, 2014
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·August 20, 2010
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
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026