20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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