19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLOWERS NASAL IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRU® Prosthetic Screw NP .050" Hex, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549112867·TRU Prosthetic Screw NP .048" Hex. The TRU Pro...
MODEL 9200 RESPIRATION/HEART RATE MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.
FDA 510(k)
FDA Class 2
·Neurology
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 23, 2014
COTTON TIP APPLICATOR IN CUSTOM PACK
FDA Adverse Event
Other
·MEDLINE INDUSTRIES, INC.·Product code MPN·January 3, 2013
FREEDOM CONSTRAINED ACETABULAR CUP ALL POLY STANDARD FACE LINER 50MM X 36MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWZ·November 22, 2010
AXIOM Artis BA, Model Number 5904656
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
AXIOM Artis BA, Model Number 5904656
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 7, 2018
AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755 Angiographic X-ray System
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·September 9, 2010
Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 6, 2017
Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 7, 2018
Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 7, 2018
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 17, 2016
ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 17, 2016
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 17, 2016
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015