28 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ACCU-CHEK ® GUIDE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·November 15, 2023
ACCU-CHEK GUIDE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·May 3, 2021
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MINIMED PARADIGM INSULIN PUMP, MODEL 511
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 1, 2024
Widex
FDA UDI
Widex A/S·05706069721638·Widex UNIQUE U-FS BTE (Winter silver S-440 ) Te...
Widex
FDA UDI
Widex A/S·05706069721140·Widex BEYOND B-F2 (Winter silver S-440 ) Teleco...
Widex
FDA UDI
Widex A/S·05706069722635·Widex CLEAR440 C4-FS BTE (Winter silver S-440 )...
Widex
FDA UDI
Widex A/S·05706069722376·Widex D-PA BTE (Winter silver S-440 ) RC coil
Widex
FDA UDI
Widex A/S·05706069721959·Widex D-FS BTE (Winter silver S-440 ) Telecoil,...
Widex
FDA UDI
Widex A/S·05706069720860·Widex UNIQUE U-PA BTE (Winter silver S-440 ) RC...
Widex
FDA UDI
Widex A/S·05706069720150·Widex D-9 BTE (Winter silver S-440 ) Telecoil, ...
MAGNUM DISPOSABLE CORE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FCG·May 1, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 10, 2011
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC SWISS MANUFACTURING FACILITY·Product code LGW·August 7, 2008
THROMBUSTER II
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code MMY·March 17, 2014
THROMBUSTER II
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code DXE·October 23, 2012
THROMBUSTER II
FDA Adverse Event
Malfunction
·KANEKA CORP.·Product code DXE·December 21, 2012
THROMBUSTER II
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code DXE·January 16, 2019