12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SUNCO Mechanical Wheelchair, model SKW-9003
FDA 510(k)
FDA Class 1
·Physical Medicine
CoRoent
FDA UDI
Nuvasive, Inc.·00887517577771·CoRoent Ant TLIF PEEK, 15x13x32mm 8°
AGC KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304222007·
BIOSPLINT SPLINTING RIBBON
FDA 510(k)
FDA Class 2
·Dental
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
FDA 510(k)
FDA Class 1
·General Hospital
N/A
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·June 8, 2013
ESCAPE NITINOL STONE RETRIEVAL BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FFL·August 21, 2008
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD.·Product code HQL·September 5, 2008
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
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