8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EBI DFS JOINT FIXATOR, MODEL 02800
FDA 510(k)
FDA Class 2
·Orthopedic
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981483·anteriors; shade BL2; mould UM4
XTAG RESPIRATORY VIRAL PANEL
FDA 510(k)
FDA Class 2
·Microbiology
Tranquil Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JFY·February 27, 2013
8800
FDA Adverse Event
Malfunction
·GE MED SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·February 1, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·August 5, 2014
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025