12 results · 20ms · Sources: EU EUDAMED, US FDA

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CX30N (CX30PQX)

FDA 510(k)
FDA Class 2 ·Radiology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517566867·CoRoent Ant TLIF PEEK, 16x10x34mm 8°

BINAX NOW COVID-19 AG CARD

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 24, 2021

UNIVERSAL CLAMP SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 13, 2011

CARELINK

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code DXY·June 10, 2013

COLLEAGUE VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: 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·January 21, 2015

Artis zee/ zeego systems; 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·August 26, 2015

The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

Siemens Artis zee 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