14 results · 22ms · Sources: EU EUDAMED, US FDA

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Microcyn Plus Skin and Wound Hydrogel

FDA 510(k)
FDA Unclassified ·Unknown

CS 2100

FDA UDI
CARESTREAM HEALTH, INC.·60889975153643·CS 2100 110V/170CM SHORT WALL MTD

COLLAGEN POWDER

FDA 510(k)
FDA Unclassified ·Unknown

PIONEER TC8080, COMPANION III

FDA 510(k)
FDA Class 2 ·Radiology

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MPRI·Product code LWS·June 8, 2013

SELUTE PICOTIP

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·July 7, 2011

2600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 11, 2008

iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

Artis zee biplane, Model Number 10094141

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

Artis zee biplane, Model Number 10094141

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

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

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

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