12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·April 23, 2024
MELIDE FIBEROPTIC LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADVANIX DOUBLE PIGTAIL BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WAVEWRITER ALPHA PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 14, 2025
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 7, 2013
CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
C-QUR MOSAIC
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code FTL·October 9, 2015
ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012