16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK
FDA 510(k)
FDA Class 2
·Dental
ITOTAL IDENTITY FEMORAL CUT GUIDE LARGE
FDA UDI
Conformis, Inc.·00810933030513·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450180488·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450180815·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450180471·
NPAC MULTI-USE THERMOMETER, MODEL TD400
FDA 510(k)
FDA Class 2
·General Hospital
FLUROPERM 60-OK, PARAGON HDS-OK
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
COBAS® HIV-1
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code MZF·August 28, 2025
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 26, 2013
VASOVIEW HEMOPRO 2 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·April 7, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Death
·CORDIS LLC (PR)·Product code NIQ·July 21, 2008
ADVIA CENTAUR TOXOPLASMA M (TOXO M)
FDA Adverse Event
Injury
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·October 22, 2012
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014