15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fusion Quattro Extraction Balloon
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FUSION QUATTRO EXTRACTION BALLOON
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code GCA·December 10, 2024
FUSION QUATTRO EXTRACTION BALLOON
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code GCA·June 7, 2024
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777587·LUMBAMED BASIC DORSAL STAY WM SILVER I
Instrument Tray
FDA UDI
Treace Medical Concepts, Inc.·00810111223423·Instrument Tray
PROFYLE
FDA UDI
Stryker GmbH·07613153160052·Insertion Drill Guide
COLORADO 2 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
FDA 510(k)
FDA Class 2
·Ophthalmic
GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC.·Product code PZE·December 2, 2021
TANDEM T:SLIM DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·October 22, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
ROTALINK? PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code MCX·July 1, 2013
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·July 20, 2016
AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
FDA Enforcement
Class II
·Terminated·Vision Rt Inc·January 14, 2015
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021