13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACUITY UNIVERSAL CUTTER
FDA 510(k)
FDA Class 2
·Cardiovascular
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604701·Knee Crutch Pads
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014603612·Knee Crutch Pads (Pair)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450382998·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450047514·
NA
FDA UDI
STRYKER CORPORATION·07613327052305·Trocar, Pyramidal Tip
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VT-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CUSTOM CONVENIENCE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code BYX·June 29, 2005
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 6, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 17, 2008
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