9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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G Surgical Marksman MIS System
FDA 510(k)
FDA Class 2
·Orthopedic
HUMIDAIR STANDARD TUBE
FDA Adverse Event
Malfunction
·RESMED CORP.·Product code BZD·October 9, 2025
SPY Portable Handheld Imaging (SPY-PHI) System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STRAUMANN CARES SCREW RETAINED BARS/BRIDGE
FDA 510(k)
FDA Class 2
·Dental
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 10, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·July 22, 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