12 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ChestView US
FDA 510(k)
FDA Class 2
·Radiology
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981247539·No-Profile Interbody, 43mm x 30mm x 16mm, 20 Deg
QUATTRODE LEAD WIDE SPACED, 60 CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·March 19, 2023
QUATTRODE LEAD WIDE SPACED, 60 CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·March 19, 2023
NEURA WRAP NERVE PROTECTOR
FDA 510(k)
FDA Class 2
·Neurology
RS80A DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 28, 2025
PLUM A+ PUMP
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·November 19, 2008
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·September 2, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 2013
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
FDA Enforcement
Class I
·Terminated·Synthes, Inc.·August 27, 2014
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