20 results · 22ms · Sources: EU EUDAMED, US FDA

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8plant Implant System

FDA 510(k)
FDA Class 2 ·Dental

MEDLINE BIOPSY VALVE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MyCRO Band

FDA 510(k)
FDA Class 2 ·Neurology

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FPA·September 1, 2011

ADVANCE MALE SLING SYSTEM

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·July 15, 2013

TRUENESS

FDA Adverse Event
Malfunction ·SINOCARE INC·Product code NBW·November 3, 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

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

TRUENESS

FDA Adverse Event
Malfunction ·SINOCARE INC·Product code NBW·April 28, 2026

TRUENESS

FDA Adverse Event
Malfunction ·SINOCARE INC·Product code NBW·February 9, 2026

TRUENESS

FDA Adverse Event
Malfunction ·SINOCARE INC·Product code NBW·February 25, 2026

Revogene, Catalog no. 610210. IVD test instrument

FDA Enforcement
Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022