8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
I.M.A. RETRACTOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575304516·Femoral Cutting Block, CCK, Distal Cut
LZI Fentanyl Enzyme Immunoassay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
TERUMO CDI 101 MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTY·October 1, 2010
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 16, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020