8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMALL VAGINAL/RECTAL ELECTRODE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FITC anti-human CD64
FDA UDI
BIOLEGEND, INC.·00810034701152·URL: https://www.biolegend.com/en-us/products/f...
LOUSEBUSTER
FDA 510(k)
FDA Class 1
·General Hospital
Dexcom G6 Continuous Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALARIS PUMP MODULE ADMIN SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·June 27, 2014
PDC IMPLANT
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·February 28, 2013
ENDURON NEUT 56 OR 68ODX28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 31, 2011
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 5, 2024