10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Riptide Aspiration System
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113752·GIANNETTI POST CAPS CANNULA
TAPERLOC COMPLETE RASP/PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304632387·
FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
FDA 510(k)
FDA Class 2
·Microbiology
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
FDA 510(k)
FDA Class 2
·Hematology
TRIAGE CARDIO PANEL
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code MMI·November 21, 2008
UNIFY CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 11, 2011
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·July 23, 2013
VANGUARD COMPLETE KNEE FEMUR RIGHT 60MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·February 27, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025