9 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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GALENICA'S DISPOSABLE ANOSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UltraClip® II Breast Tissue Marker
FDA UDI
Bard Peripheral Vascular, Inc.·00801741000331·ULTRACLIP® II breast tissue marker 17g x 10cm ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694025348·EnCompass 17mm Drill Guide
True HD 3MOS Camera System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EASYSPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 7, 2010
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYTEMS INC·Product code LZG·December 3, 2012
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