11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Accu-Chek Guide Me Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704512533·
FIDUCIAL MARKERS
FDA 510(k)
FDA Class 2
·Radiology
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
FDA 510(k)
FDA Class 2
·Physical Medicine
EMBOLD¿ PACKING
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRD·May 30, 2025
BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 19, 2022
CATH 5F INFINITI TL 3DRC 100CM
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code DQO·June 21, 2013
ON-Q PAINBUSTER SOAKER 5" EXPANSION KIT
FDA Adverse Event
Injury
·I-FLOW CORPORATION·Product code BSO·July 22, 2011
LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code MAF·September 30, 2008
3.5MM LCP SUPERIOR CLAVICLE PLATE/8 HOLE/RIGHT/115MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·November 20, 2018
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021