9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NANNOLIGHT INTENSE PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS
FDA 510(k)
FDA Class 2
·General Hospital
MULTIFUNCTION ENDOSCOPIC INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012
ASR UNI FEMORAL IMPL SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 26, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 21, 2008
TI END CAP FOR TFNA 0MM EXTN - STERILE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HSB·November 17, 2023
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