12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604718·Toboggan Arm & Leg Guard Pad, Small
n/a
FDA UDI
Ortho Development Corporation·00822409075256·Distal Reamer 15.5mm
NA
FDA UDI
STRYKER CORPORATION·07613327052312·Trocar, Pyramidal Tip
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
DYNA-LOK CLASSIC SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 14, 2025
FORTIFY ASSURA DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·April 26, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 6, 2011
UNKNOWN DEPUY FEMUR
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSA·July 18, 2008
ULTRA 2 CUTTING BALLOON
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 4, 2010
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