10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESICEM
FDA 510(k)
FDA Class 2
·Dental
PerforMax
FDA UDI
Respironics, Inc.·00606959007727·PerforMax Mask with Standard Elbow, Single Use,...
iTotal STEM DRILL 10MM W/ HUDSON ADAPTOR
FDA UDI
Conformis, Inc.·00810933030254·
Clamp, Hysterectomy, model Z 24cm strongly curved shanks angled
FDA UDI
Geister Medizintechnik GmbH·04057034373187·Clamp, Hysterectomy, model Z
24cm s...
LIFE SCOPE EC, MODEL BSM-1102
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVANTA SST GRAFT (<6MM)
FDA 510(k)
FDA Class 2
·Cardiovascular
BRILLANCE BIGBORE ONCOLOGY
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·April 24, 2013
SINGLE EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 22, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·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