10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LCP
FDA UDI
Synthes GmbH·10886982165961·3.5MM LCP T-PLATE 3H HEAD/ 4H SHAFT/57MM-RIGHT ...
RANDOX CANNABINOIDS ASSSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MAMMAPRINT FFPE
FDA 510(k)
FDA Class 2
·Immunology
CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HWE·May 18, 2026
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FRN·November 10, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 9, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 22, 2013
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·January 12, 2026
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