11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450179857·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450179802·
REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
KIMAX, MODEL 1024
FDA 510(k)
FDA Class 2
·Radiology
RIATA PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 6, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·July 21, 2008
145-DEG PE 38MM CONST HUM LINER +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·November 5, 2024
RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·November 6, 2024
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014