9 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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Vave Wireless Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
LCP
FDA UDI
Synthes GmbH·10886982165596·3.5MM LCP T-PLATE 3H HEAD/ 5H SHAFT/74MM-OBLIQU...
RAICHEM BUN RATE REAGENT (LIQUID)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARTMATE XVE LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·November 20, 2008
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 17, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 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
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020