9 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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SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014607061·SKYTRON 3100 4" SOFTCARE
DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PORTABLE INTENSIVE CARE UNIT, MODEL PIC
FDA 510(k)
FDA Class 2
·Anesthesiology
PINN CAN BONE SCREW 6.5MMX20MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·April 26, 2013
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER.
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 6, 2011
CENTRIMAG
FDA Adverse Event
LEVITRONIX GMBH·Product code DWA·July 24, 2008
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
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