10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
FDA 510(k)
FDA Class 2
·Physical Medicine
Oticon
FDA UDI
Sbo Hearing A/S·05714464058822·OTICON MORE 1 MINIRITE T C063 DEMO
LEONE SPA
FDA UDI
LEONE SPA·08033707040354·ANDREWS DB BRACKETS 22 BH KIT
MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0
FDA 510(k)
FDA Class 2
·General Hospital
A&I SCOOTER, SC-402
FDA 510(k)
FDA Class 2
·Physical Medicine
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 9, 2011
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 22, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014