11 results
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24ms
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Sources: EU EUDAMED, US FDA
MEDGRAPHIX INTL VR 1000 SERIES
FDA 510(k)
FDA Class 2
·Radiology
Liofilchem MIC Test Strip (MTS)
FDA UDI
LIOFILCHEM SRL·08055182870196·MIC Test Strip is a quantitative assay for dete...
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VIEWFLEX XTRA ICE CATHETER
FDA 510(k)
FDA Class 2
·Radiology
E1 RINGLOC BIPOLAR 28X51MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·June 17, 2019
BIOMEX SHELL PC DIA48MM LN 22
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 2, 2015
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·January 17, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 6, 2014
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 21, 2015
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 21, 2015