12 results · 22ms · Sources: EU EUDAMED, 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