9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ABC-1000 SMALL JOINT REAMERS
FDA 510(k)
FDA Class 1
·Orthopedic
SYNTHES ORACLE SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
MUMPS S & V ANTIGENS & CONTROLS
FDA 510(k)
FDA Class 1
·Microbiology
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 9, 2010
EXCEL 210 SE
FDA Adverse Event
Malfunction
·DATEX-OHMEDA·Product code BSZ·February 20, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·December 10, 2012
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025