15 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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LITECURE THERAPY SYSTEM MODEL LTS-1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193100227·EVOS Straight HA PEEK 14mm x 9mm x 26mm Biconve...
Spine Innovation Interbody System
FDA UDI
SPINE INNOVATION, LLC·00817722020366·Expandable Implant 5° x 12mm W x 14mm H x 30mm L
UniTip Catheter
FDA UDI
Unisensor AG·07640172973547·
MIRADRY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIANOX DELIVERY SYSTEM, MODEL I
FDA 510(k)
FDA Class 2
·Anesthesiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 21, 2013
SUR-FIT NATURA 2 PC DURAHESIVE MODABLE WAFER
FDA Adverse Event
Injury
·CONVATEC INC.·Product code EXE·September 3, 2014
DEPUY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·June 7, 2011
ARTIS Q, Interventional Fluroscopic x-ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 29, 2017
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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-zee/zeego and 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 zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017
Artis Q/ Q zen systems; Artis Q/ Q zen systems are 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·April 22, 2015
Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 21, 2020
Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 26, 2018
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is 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 Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018