20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONTOUR NEXT BLOOD GLUCOSE METER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·April 29, 2014
CONTOUR
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 5, 2019
Aequalis™ Adjustable Reversed
FDA UDI
TORNIER, INC.·00846832059843·
CHS
FDA UDI
Smith & Nephew, Inc.·03596010062628·COMPRESSION HIP SCREW SUPER LAG SCREW 105MM
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776296889·Fomon Retractor Double Ball 6.5" 9mm wide
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197162661·Micro Hook
90°, b...
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
FDA 510(k)
FDA Class 2
·Hematology
LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·August 30, 2013
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 20, 2013
UNKNOWN DEPUY ASR HEAD
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KXA·June 1, 2011
ACCESS ACCUTNI REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·September 15, 2016
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 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 floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 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
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023