12 results
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17ms
·
Sources: EU EUDAMED, US FDA
CW DOPPLER STATIC TRANSDUCERS
FDA 510(k)
FDA Class 2
·Radiology
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981285838·Trial 16x12x9mm, 7 Deg Lordosis, w/ Depth Stop
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861109000·Standard Band, Tooth 45-44/34-35, Size 9
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861109180·Standard Band, Tooth 44/34, Size 9/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861109220·Standard Band, Tooth 44/34, Size 9/Roth 22
TERRYCLOTH BIBS
FDA 510(k)
FDA Class 1
·General Hospital
iSR'obot MRI-US Fusion
FDA 510(k)
FDA Class 2
·Radiology
OPTIFLUX 180NRE DIALYZER FINISHED ASSY
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·April 14, 2014
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 4, 2010
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 4, 2012
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012