15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TGS Universal Headrest with Mounting Arm
FDA 510(k)
FDA Class 2
·Neurology
Reveal
FDA UDI
Oticon A/S·05707131343178·G20, MINIRITE 312 2.4G C090 REVEAL
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180543986·Nerve Retractor, Medium
CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
FDA 510(k)
FDA Class 2
·Immunology
VARI-LASE ENDOVENOUS LASER CONSOLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 23, 2025
MONOJECT
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD·Product code PNR·April 14, 2024
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024
CARDINAL
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024
BD Microtainer SST- Amber Part/Catalog Number: 365978
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
GYNECARE MORCELLEX TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·October 8, 2008
ACHIEVE MAPPING CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC ABLATION FRONTIERS·Product code DRF·June 27, 2013
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·August 5, 2011
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.
FDA Enforcement
Class II
·Terminated·Thoratec Corp.·May 1, 2019