8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BURETTE INTRAVENOUS ADMIN. SETS.
FDA 510(k)
FDA Class 2
·General Hospital
Daytona® Small Stature
FDA UDI
Seaspine Orthopedics Corporation·10889981185114·Precontoured Ti Rod, 4.5 x 130mm
ELEOS Bipolar Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
OCCLUFAST CAD
FDA 510(k)
FDA Class 2
·Dental
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 10, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 7, 2014
COAGUCHEK XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·September 21, 2007
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025