17 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ShurFit Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
LuxaGlaze®
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2120750·Light-curing high-gloss varnish for temporaries...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112601·BARRON CORNEAL PUNCH 7.25MM
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929002834·Cervical PEEK, 6°, 12mm W x 12mm D x 7.5mm H
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929002841·Cervical PEEK, 0°, 12mm W x 12mm D x 7.5mm H
VITEK 2 STRPTOCOCCUS AMPICILLIN
FDA 510(k)
FDA Class 2
·Microbiology
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6
FDA 510(k)
FDA Class 2
·Microbiology
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLOW TREATMENT
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·October 23, 2008
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·July 8, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 8, 2013
BD NEXIVA SINGLE PORT
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 5, 2024
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 22, 2022
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023
CEFALY
FDA Adverse Event
Injury
·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026
CEFALY
FDA Adverse Event
Injury
·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2022
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021