9 results
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27ms
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Sources: EU EUDAMED, US FDA
CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.
FDA 510(k)
FDA Unclassified
·Unknown
JOBST Travel Sock
FDA UDI
BSN MEDICAL, INC.·04042809259902·TRAVEL SOCKS 15-20 MM HG KNEE HIGH CLOSED TOE S...
THE PROTECTOR
FDA 510(k)
FDA Class 1
·Anesthesiology
PRESERV PVA FIXATIVE 15ML-FORMALIN PK
FDA 510(k)
FDA Class 1
·Pathology
SP2 TIBIAL RADEL IMPACTOR
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LXH·June 19, 2014
AQUACEL AG
FDA Adverse Event
Injury
·CONVATEC·Product code FRO·October 25, 2010
NON-POWERED TRACTION APPARATUS AND ACCESSORIES
FDA Adverse Event
HL CORP. (SHENZHEN)·Product code FNL·December 22, 2012
WATER BATH HEATER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JTQ·January 24, 2019
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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