7 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Prestige Coil System
FDA 510(k)
FDA Class 2
·Cardiovascular
TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 3, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·August 23, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·July 8, 2013
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026