20 results
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19ms
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Sources: EU EUDAMED, US FDA
TETRACHROME REAGENTS AND TETRACXP SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1214450·12mm H x 14mm W x 45mm L x 0 degrees XLIF
Lasik Sweep
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896103023·Cornell Lasik Sweep Single End Semi Sharp Tip T...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741214450·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X12144580·12mm H x 14mm W x 45mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X121445120·12mm H x 14mm W x 45mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L121445120·12mm H x 14mm W x 45mm L XLIF Trial 12 degree L...
SafeGuide®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734021132·Esophageal Dilator, 45 French
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674121445060·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970386·
MaxFuse VBR, 10 (D) x 12 (W) x 55 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055653·10 (D) x 12 (W) x 55 (H)
ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
FDA 510(k)
FDA Class 2
·Microbiology
VITAL SIGNS MONITOR-VSM 6000 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 29, 2014
BIVONA CUSTOM TTS HYPERFLEX TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·May 6, 2011
Artis Q (material 10848280, 10848281, 10848282) - Product Usage: 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 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 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·May 22, 2019
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 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.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020
Artis Q biplane, Model Number 10848282
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
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