7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AccuCath Intravascular Catheter
FDA 510(k)
FDA Class 2
·General Hospital
ALPHASPHERE ORBITAL IMPLANT
FDA 510(k)
FDA Class 2
·Ophthalmic
ACAM 5 AUDIOMETER SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
REVO MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWP·June 8, 2013
MEMBRAGEL
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code NPK·June 30, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·September 8, 2008
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023