10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEUROSURGICAL INSTURMENTS (VARIOUS)
FDA 510(k)
FDA Class 1
·Neurology
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809641073·OPAQUE MATERNITY 20-30 MM HG KNEE HIGH ZIG ZAG ...
EndoEssentials™ Gutta Percha Points Size 30 .06 Taper w MM Markings
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172014779·Polymer-based endodontic gutta percha
KINEMATIC ROTATING HINGE TOTAL KNEE PR.
FDA 510(k)
FDA Class 2
·Orthopedic
Provicol QM Plus
FDA 510(k)
FDA Class 1
·Dental
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·November 29, 2012
COMP CONV GLEN LINER E1
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·April 22, 2021
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