9 results · 18ms · Sources: EU EUDAMED, US FDA

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GREINER VACUETTE BLOOD COLLECTION TUBE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PEEK Corpectomy

FDA UDI
Nuvasive, Inc.·00887517623102·PEEK Corp Core, Ø12x20mm

Bioseal Inc.

FDA UDI
BIOSEAL·00630094197128·Silicone Tubing

T3 RIA TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

COLUMBUS TOTAL KNEE SYSTEM AS

FDA 510(k)
FDA Class 2 ·Orthopedic

PELVICOL ACELLULAR COLLAGEN MATRIX 4 X 7 CM

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·February 6, 2013

MEDISENSE OPTIUM

FDA Adverse Event
Malfunction ·Product code NBW·January 26, 2011

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 31, 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