27 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TriALTIS Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506
FDA 510(k)
FDA Class 2
·Cardiovascular
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
DUAL EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·November 3, 2025
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 11, 2025
TRUENESS
FDA Adverse Event
Injury
·SINOCARE INC·Product code NBW·October 15, 2025
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC.·Product code NBW·November 28, 2025
TRUENESS
FDA Adverse Event
Injury
·SINOCARE INC ADDRESS LINE 1 NO.265 GUYUAN·Product code NBW·October 20, 2025
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·May 29, 2026
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 13, 2025
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·March 11, 2026
TRUENESS AIR
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·February 26, 2026
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·October 20, 2025
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·November 19, 2025
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC.·Product code NBW·October 10, 2025