10 results
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26ms
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Sources: EU EUDAMED, US FDA
Navigated Instruments
FDA 510(k)
FDA Class 2
·Neurology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197534826·Zlider TAKAHASHI Nasal Forceps B 2.5 mm
120 mm...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197534819·Zlider TAKAHASHI Nasal Forceps BL 2.5 x
10 mm ...
HEPASPHERE MICROSPHERES
FDA 510(k)
FDA Class 2
·Cardiovascular
Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
FDA 510(k)
FDA Class 2
·Radiology
ETHILON NYLON SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·December 7, 2018
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 29, 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