9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES
FDA 510(k)
FDA Class 1
·Microbiology
CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
FDA 510(k)
FDA Class 2
·Orthopedic
Elevo® Kit Snoring Intervention Device
FDA 510(k)
FDA Class 2
·Dental
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 18, 2014
IAB: 8 FR - 30 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·October 1, 2010
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 16, 2012
MEDTRONIC CRT-D
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NIK·August 21, 2024
MEDTRONIC CRT-D
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code NIK·August 22, 2024
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026