29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERTEX THERMOSENS RIGID
FDA 510(k)
FDA Class 2
·Dental
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180515242·Zodiac Pedicle Marker, Cylinder
VOYAGER PERITONEAL DIALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VARISOURCE BREAST TEMPLATE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EMERGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 27, 2024
EMERGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 29, 2025
EMERGE?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·May 19, 2026
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 4, 2021
EMERGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 8, 2026
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 30, 2026
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·January 30, 2026
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 3, 2021
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·October 28, 2025
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 26, 2026
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 21, 2026
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTL·August 4, 2008
M2A MAGNUM MODULAR HEAD 46MM HEAD DIAMETER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 29, 2016
EMERGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 4, 2026