13 results
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18ms
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Sources: EU EUDAMED, US FDA
#50002 QUAD DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
CODMAN® ACCU-FLO®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780517498·CODMAN® ACCU-FLO® Distal Slit Valve Barium Cath...
CODMAN® ACCU-FLO®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780536819·CODMAN® ACCU-FLO® Distal Slit Valve Barium Cath...
CODMAN ACCU-FLO
FDA UDI
Cerenovus, Inc.·10886704040309·CODMAN ACCU-FLO Distal Slit Valve Barium Cathet...
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268213011·CUSTOM SURGICAL KIT VEIN
VBR™ vertebral body replacement
FDA UDI
Ulrich GmbH & Co. KG·04052536076116·VBR center piece, size S, Ø 28 mm, height 82-13...
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
XPRESSWAY RX CATHETER (6F LD-VERISON)
FDA 510(k)
FDA Class 2
·Cardiovascular
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014
PUMP MMT-722CAS PRDGM INS V2.2 SK EN PR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code CGA·October 21, 2010
BASIC CONFIGURATION MODEL 6100 BASE
FDA Adverse Event
Malfunction
·STRYKER CORP. MEDICAL DIVISION·Product code FPO·August 26, 2010
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012