10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604787·3" STANDARD ARMBOARD PAD
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450180280·
BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code LJS·October 29, 2007
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
FDA 510(k)
FDA Class 2
·Ophthalmic
VERTE-STACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TVL LEAD, RIGHT VENTRICULAR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
PENUMBRA COIL 400
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·April 7, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·July 21, 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