11 results
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26ms
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Sources: EU EUDAMED, US FDA
MAX ADJUSTING INSTRUMENT
FDA 510(k)
FDA Unclassified
·Unknown
Malecot
FDA UDI
COOK INCORPORATED·00827002143326·Large Malecot Nephrostomy Accessory Set
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
FDA 510(k)
FDA Class 2
·Cardiovascular
NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE
FDA 510(k)
FDA Class 1
·General Hospital
2.0MM PARALLEL DRILL GUIDE AND DRILL SLEEVE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code FZX·April 29, 2013
UNIVERSAL DRIVER SHAFT
FDA Adverse Event
Malfunction
·STRYKER·Product code HXX·May 3, 2011
ACE INSTANT COLD COMPRESS
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code IMD·July 25, 2008
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·September 27, 2018
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·November 14, 2012
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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