11 results
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19ms
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Sources: EU EUDAMED, US FDA
Disposable Stone Retrieval Balloon Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ritter
FDA UDI
MIDMARK CORPORATION·00841709106323·The Ritter 253 LED Exam Light provides focusabl...
RUNTHROUGH
FDA UDI
TERUMO CORPORATION·04987350721006·RUNTHROUGH NS HYPERCOAT PTCA Guidewire
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
FDA 510(k)
FDA Class 2
·General Hospital
AGNES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITAGEL SURGICAL HEMOSTAT
FDA Adverse Event
Injury
·STRYKER ORTHOBIOLOGICS·Product code LMF·February 24, 2012
VITAGEL SURGICAL HEMOSTAT
FDA Adverse Event
Injury
·STRYKER ORTHOBIOLOGICS·Product code LMF·February 24, 2012
MAXPLUS EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·August 31, 2011
ENDOSCOPIC MULTIFEED STAPLER - 360 ROTATION 20 TITANIUM STAPLES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GCJ·December 9, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 29, 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