10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHARLOTTE CLAW 3.5
FDA 510(k)
FDA Class 2
·Orthopedic
Aligned Medical Solutions
FDA UDI
Aligned Medical Solutions·B09800802950·Dialysis Dressing Change Tray-RX
LEONE SPA
FDA UDI
LEONE SPA·08033707001034·MICRO SECT SCREWS HIGH/U S/STEEL 13mm
QUICK COMBO PAD
FDA Adverse Event
Injury
·PHYSIO CONTROL CORP.·Product code MLN·January 17, 1997
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICROSTIM 100I TENS DEVICE
FDA 510(k)
FDA Class 2
·Neurology
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 26, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·March 31, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 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