7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
BAXANO ULTRA LOW PROFILE RONGEUR
FDA 510(k)
FDA Class 2
·Neurology
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
FDA 510(k)
FDA Class 2
·Hematology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·April 26, 2013
GASTROINTESTINAL ANCHOR SET WITH HEMOSTAT
FDA Adverse Event
Injury
·KIMBERLY-CLARK HEALTH CARE·Product code KNT·May 6, 2011
EEA 31MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·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