8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
RADKOR, CST-18
FDA 510(k)
FDA Class 1
·Radiology
TRANSETTE SYSTEM/COLLECTION & TRANSP
FDA 510(k)
FDA Class 1
·Microbiology
SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
FDA 510(k)
FDA Class 2
·Cardiovascular
DRILL, TRI-FLAT T2 TIBIA Ø3,5X130 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HWE·June 19, 2014
ARCHITECT C16000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·October 26, 2010
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FMG·December 20, 2012
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020