10 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VARIAX DISTAL RADIUS TORX SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Cordera Hip System
FDA UDI
Conformis, Inc.·00810933031350·Cordera Cup Acetate -120% Magnification Template
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
VERCISE GEVIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·June 24, 2024
M2A-MAGNUM 42-50 TPR INSRT STD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 26, 2013
COULTER® ACT DIFF2 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·May 6, 2011
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·July 22, 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