28 results · 31ms · Sources: EU EUDAMED, 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