9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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P.F.C. SIGMA INSET PATELLA
FDA 510(k)
FDA Class 2
·Orthopedic
HEMOCUE WBC SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
Fresenius Liberty Select Cycler
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INVISION-PLUS
FDA Adverse Event
Malfunction
·RYMED TECHNOLOGIES, LLC·Product code FPA·July 7, 2022
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTO·February 21, 2013
CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - TAMPA·Product code FKX·January 27, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 31, 2014
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
FDA Recall
Terminated
·TEM Systems Inc·Product code JPA·October 23, 2014
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