10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DS Core Detect
FDA 510(k)
FDA Class 2
·Radiology
ARx SAI
FDA UDI
Life Spine, Inc.·00190837196417·
ARx SAI
FDA UDI
Life Spine, Inc.·00190837175931·
ULTRA Telescopes
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC·Product code GDW·December 3, 2008
UNKNOWN DEPUY SZ 4 PS RT FEMORAL COMPONENT
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code KWY·September 19, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 29, 2013
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·February 4, 2015
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