11 results
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26ms
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Sources: EU EUDAMED, US FDA
FORMALDEHYDE SOLUTION, 37%
FDA 510(k)
FDA Class 1
·Pathology
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746162947·SUPPLIES - ORTHO WAX BITES 28/PKG
Ortho Wax Bites
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746035081·SUPPLIES - ORTHO WAX BITES 28/PKG
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746162978·SUPPLIES - ORTHO WAX BITES 28/PKG
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746034909·SUPPLIES - ORTHO WAX BITES 28/PKG
ClearRead CT
FDA 510(k)
FDA Class 2
·Radiology
DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·October 4, 2010
CUSTOMER CURVED QUICK-CONNECT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·November 2, 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