10 results
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27ms
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Sources: EU EUDAMED, US FDA
iCEM Universal Plus
FDA 510(k)
FDA Class 2
·Dental
Mirror Suction - Handle (Gray)
FDA UDI
HAGER WORLDWIDE, INC.·D2482540630·mouth mirror evacuation tip handle only
Mirror Suction - Handle (Gray)
FDA UDI
HAGER WORLDWIDE, INC.·00014081540638·mouth mirror evacuation tip handle only
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T2Candida 1.1 Panel
FDA 510(k)
FDA Class 2
·Microbiology
TRIDENT 0° X3 INSERT 32MM ID
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·September 4, 2013
COGNIS HE IS-1/DF-1/IS-1
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 19, 2011
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·July 30, 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