9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
SWANSON TITANIUM CARPAL LUNATE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000
FDA 510(k)
FDA Class 2
·Cardiovascular
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 15, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2014
UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·January 20, 2011
FT3 - FREE TRIIODOTHYRONINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·October 10, 2014
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017