8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RenaNav Ureteroscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DOSE TRACKING SYSTEM MODEL XIDF-DTS801
FDA 510(k)
FDA Class 2
·Radiology
TRUEZONE PEAK FLOW METER
FDA 510(k)
FDA Class 2
·Anesthesiology
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·August 10, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 4, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2013
TARGET DEVICE GAMMA3®
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·August 18, 2015
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018