11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Penumbra Smart Coil
FDA 510(k)
FDA Class 2
·Neurology
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·December 11, 2015
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837088965·
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
KOKO LEGEND
FDA 510(k)
FDA Class 2
·Anesthesiology
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
RESERVOIR 1.8 ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·June 28, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
IMMULITE® 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·December 11, 2024
IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT (SPE)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·October 1, 2022
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014