12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
FDA 510(k)
FDA Class 2
·Radiology
Spud
FDA UDI
KATENA PRODUCTS, INC.·00841668101216·FRANCIS FOREIGN BODY SPUD
Bioplate®
FDA UDI
Bioplate, Inc.·M384K248500·Maxfax Set Basic
Apelo® / Apelo® MIS
FDA UDI
ATLAS SPINE, INC.·M68169102408500·8.5mm Cannulated Screw Kit
TSY SHOULDER PLATE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
GENESIS REUSABLE RIGID CONTAINER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
MY3D PERSONALIZED SOLUTIONS
FDA Adverse Event
Injury
·ONKOS SURGICAL·Product code KRO·December 8, 2025
WARM PACK, INSTANT, GEL, 6"X6"
FDA Adverse Event
Other
·MEDLINE INDUSTRIES, INC.·Product code IMD·November 12, 2008
HOYER HML 400
FDA Adverse Event
Malfunction
·APEX HEALTHCARE MFG INC·Product code FNG·August 8, 2011
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·July 16, 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