8 results
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33ms
·
Sources: EU EUDAMED, US FDA
XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809643817·OPAQUE MATERNITY 20-30 MM HG WAIST HIGH ZIG ZAG...
ZIRCONIA IMPLANT
FDA 510(k)
FDA Class 2
·Dental
Bindex BI-2
FDA 510(k)
FDA Class 2
·Radiology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014
MAXTORQUE ZP
FDA Adverse Event
Injury
·ORTHOHELIX SURGICAL DESIGNS·Product code HWC·October 5, 2010
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 31, 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