27 results · 22ms · Sources: EU EUDAMED, 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