10 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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E.W.L. P-TENS/H-WAVE
FDA 510(k)
FDA Class 2
·Physical Medicine
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862121180·Standard Band, Tooth 45/35, Size 21/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862121220·Standard Band, Tooth 45/35, Size 21/Roth 22
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Siconus SI Joint Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 8, 2010
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 7, 2012
Hand Tray, part number PSS2365(F Hand Tray, part number PSS2365(G
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012