10 results
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29ms
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Sources: EU EUDAMED, US FDA
BOSS
FDA 510(k)
FDA Class 2
·Dental
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331180118·beebee (crown & collar) wire cutting scissors, ...
Portex
FDA UDI
ICU MEDICAL, INC.·10351688403285·
ACTICOAT Surgical Dressing
FDA 510(k)
FDA Unclassified
·Unknown
Branchor Balloon Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
COGNIS HE IS-1/DF-1/IS-1
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008
ASR ACETABULAR IMPLANT 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 19, 2011
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS, INC.·Product code LZG·July 30, 2013
BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·March 16, 2016
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