10 results
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20ms
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Sources: EU EUDAMED, US FDA
mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197450317·Sinuscopy Punch, double action
Ø2mm, ...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252605200·ceraMotion® Me 3D Dentin CC21, 20 g / dental ce...
Impulse Angiographic Catheter, Expo Angiographic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
EXTERNAL FIXATION
FDA 510(k)
FDA Class 2
·Orthopedic
RETAINING 2.5MM HEX DRIVE R LONG
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code NDP·January 25, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 18, 2011
ESTEEM
FDA Adverse Event
Other
·ENVOY MEDICAL·Product code OAF·July 19, 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