11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCIN BIPOLAR HEAD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Cordera Hip System Femoral Stem Extractor Handle
FDA UDI
Conformis, Inc.·00810933031084·Femoral Stem Extractor Handle
UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015
DATEX-OHMEDA NETWORK AND CENTRAL
FDA 510(k)
FDA Class 2
·Cardiovascular
SIMPLICITY INFUSER INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 26, 2013
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·April 26, 2011
LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code MAF·July 22, 2008
COPELAND THN SHL COCR/HA HUMS3
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWS·August 28, 2025
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