10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAFE VENT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Masimo Root Monitoring System and Accesories
FDA 510(k)
FDA Class 2
·Cardiovascular
DIAGNODENT PERIO TIP (ACCESSORY)
FDA 510(k)
FDA Class 2
·Dental
RADIUS-7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 2, 2015
TRIO MOBILE SURGY PLTFRM 2/08
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·February 4, 2013
ISOLINE
FDA Adverse Event
Malfunction
·SORIN BIOMEDICA CRM S.R.L.·Product code MRM·December 30, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026