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OMEC MEDICAL NV INC

FDA registration
OMEC MEDICAL NV INC·1 product·🇺🇸 United States

OEC

FDA UDI
OEC MEDICAL SYSTEMS, INC.·00840682121729·MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC ELITE

OEC

FDA UDI
OEC MEDICAL SYSTEMS, INC.·00840682114349·

OEC

FDA UDI
OEC MEDICAL SYSTEMS, INC.·00195278096944·MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC 3D

OEC

FDA UDI
OEC MEDICAL SYSTEMS, INC.·00840682114301·

DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code LXH·January 6, 2017

GE OEC 6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL INC.·Product code JAA·May 15, 2009

GE OEC 9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL INC.·Product code JAA·September 18, 2007

GE Medical Systems SCS

Authorized representative
🇫🇷 France·27 Manufacturers·564 Devices

GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.

FDA Recall
Terminated ·OEC Medical Systems, Inc·Product code JAA·August 29, 2008

OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.

FDA Recall
Terminated ·OEC Medical Systems, Inc·Product code JAA·April 15, 2008

GE OEC 9800 Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy.

FDA Recall
Terminated ·OEC Medical Systems, Inc·Product code JAA·August 12, 2008

GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.

FDA Recall
Terminated ·OEC Medical Systems, Inc·Product code JAA·July 2, 2008

OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.

FDA Recall
Terminated ·OEC Medical Systems, Inc·Product code JAA·April 15, 2008

GE OEC 9900 Elite Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy.

FDA Recall
Terminated ·OEC Medical Systems, Inc·Product code JAA·August 12, 2008

InstaTrak 3500 Navigation and Visualization System

FDA Recall
Terminated ·OEC Medical Systems, Inc·Product code LLZ·December 13, 2004

GE Healthcare OEC 9900 mobile fluoroscopic x-ray system

FDA Recall
Terminated ·OEC Medical Systems, Inc·Product code JAA·December 14, 2007

FluroTrak 9800 Plus Navigation and Visualization System

FDA Recall
Terminated ·OEC Medical Systems, Inc·Product code JAA·December 13, 2004

ENTrak Plus Navigation and Visualization System

FDA Recall
Terminated ·OEC Medical Systems, Inc·Product code LLZ·December 13, 2004

InstaTrak 3000 Navigation and Visualization System

FDA Recall
Terminated ·OEC Medical Systems, Inc·Product code LLZ·December 13, 2004