11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Oticon A/S·05707131284242·H110V2 TI, BTE 13 WL 85 SIL HHM
AGC TRADITION KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304240773·
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523103973·T³ Acetabular Hemispherical Shell, No Hole, 64mm
BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P
FDA 510(k)
FDA Class 2
·Dental
ZIEHM QUANTUM
FDA 510(k)
FDA Class 2
·Radiology
TOTAL ASR FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 6, 2013
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
Biograph mMR. Model Number: 10433372.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016