9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
FDA 510(k)
FDA Class 2
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471220263·SAGITTAL BLADE - DE SOUTTER STANDARD 29 x 60 x ...
Rapid DOA-13 Panel Test Cup
Device
EU IVDD
·
Eu Ivd General
·Xiamen Boson Biotech Co., Ltd.·On the market
HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4
FDA 510(k)
FDA Class 1
·Physical Medicine
Senhance Surgical System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT ULTRAMINI
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 4, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·January 31, 2014
ITRAK 3500
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·December 6, 2012
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