12 results
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28ms
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Sources: EU EUDAMED, US FDA
HANAROSTENT Esophagus Upper (CCC)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197181945·Dittel-Bougies, slightly curved,
35.5 c...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197181938·Dittel Dilating Bougies
Charr....
VERTACONNECT TLIF Cage
FDA 510(k)
FDA Class 2
·Orthopedic
OXICOM CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
COBAS 6000 C (501) MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 3, 2018
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 7, 2014
FINELINE II
FDA Adverse Event
Death
·CPI - DEL CARIBE·Product code NVN·September 19, 2011
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 29, 2013
1823260-2017-02642
FDA Adverse Event
Malfunction
·November 17, 2017
MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·August 10, 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