18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ECLIPSE TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
GMK REVISION HYBRID LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
PROCERA BRIDGE ZIRCONIA
FDA 510(k)
FDA Class 2
·Dental
PROPHECY INFINITY
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HSN·March 29, 2021
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013
PINNACLE SECTOR II CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 22, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 8, 2024
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 19, 2023
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·May 28, 2024
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·July 15, 2025
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·December 2, 2022
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 22, 2024
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 11, 2024
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·May 2, 2025
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·April 29, 2025
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·December 18, 2023
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018