11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604879·BERCHTOLD B810, B710 5" SOFTCARE
NA
FDA UDI
STRYKER CORPORATION·07613327052374·Hasson Cannula, Automatic Valve, Stopcock
CALEX CONDITIONER
FDA 510(k)
FDA Class 2
·Dental
HDR MIAMI APPLICATOR
FDA 510(k)
FDA Class 2
·Radiology
LINEAR ST
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 12, 2024
NANOKNIFE SYSTEM
FDA Adverse Event
Injury
·ANGIODYNAMICS·Product code OAB·June 9, 2015
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 6, 2011
FREESTYLE
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 21, 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