26 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
FDA 510(k)
FDA Class 2
·Radiology
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380077357·1.1mm Non-Threaded Guide Wire 150mm
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089448890·
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122223·KWire .045x6" (1.1x150mm)
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033412·Coupling Treatment Tube for 4F Flexibles (8)
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122216·KWire .045x6" (1.1x150mm) Threaded
CM TITAMAX EX IMPLANT 3.75X15
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·November 8, 2017
MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235
FDA 510(k)
FDA Class 2
·Radiology
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 13, 2026
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 29, 2025
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018
CD HORIZON
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·March 15, 2017
IMMULITE 2000 XPI
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJQ·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
Artis Q.zen ceiling, Model Number 10848354
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Angiography systems developed for single and biplane diagnostic imaging
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 8, 2021
Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012