9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
EBI XFIX DFS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·December 22, 2010
TRIATHLON #4 PS INSERT 13MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 2, 2013
UNK DY
FDA Adverse Event
Malfunction
·ARGYLE (SHERIDAN)·Product code MPB·March 21, 2011
U0605 6464602 PCA II PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code MEA·April 16, 2008
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016