9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Caliber Intramedullary Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Visible Patient Suite
FDA 510(k)
FDA Class 2
·Radiology
SMITH & NEPHEW HYBRID KNEE FEMORAL
FDA 510(k)
FDA Class 2
·Orthopedic
VERSATAP SUTURE ANCHOR
FDA Adverse Event
Malfunction
·ORTHO-DESIGN·Product code MBI·September 15, 2025
HYDRATOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 19, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
LCS COMP RP INSERT STD+ 10MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC·Product code NJL·July 23, 2013
PIPELINE VANTAGE WITH SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 28, 2024
Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·February 22, 2017