11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RELIEVE LAMINOPLASTY FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Cordera Hip System
FDA UDI
Conformis, Inc.·00810933031329·Cordera Stem Acetate 120% Magnification Template
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450182222·
ADARA
FDA UDI
HNM TOTAL RECON LLC·00841742102924·ADARA ø4.5mm Cortical Screw, Full Thread, SS - ...
COPELAND RESURFACING HUMERAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
PINN CAN BONE SCREW 6.5MMX35MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·April 26, 2013
MALLORY/HEAD OBLONG TROCHANTER BOLT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·May 6, 2011
ANALYTICAL P MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 22, 2008
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
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