16 results
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19ms
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Sources: EU EUDAMED, US FDA
THE POREX RETRACTOR TABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490519304·CASE 1860503 PREMIER SCREW TRAY MODULE
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78605031·Sprint II Bracket Roth .018" max. 4+5 right w. ...
LEONE SPA
FDA UDI
LEONE SPA·08033707032502·WEB 1ST MOLAR BANDS n.LR 3
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746049798·WIRE SS POSTED 018 X 025 26MM FORM I 10/PK
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78605030051·Sprint II Bracket Roth .018" max. 4+5 right w. ...
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78605031001·Sprint II Bracket Roth .018" max. 4+5 right w. ...
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78605030101·Sprint II Bracket Roth .018" max. 4+5 right w. ...
Vented Vial Adapter Transfer Device - 13mm
FDA 510(k)
FDA Class 2
·General Hospital
DIMENSION TACR CALIBRATOR, MODEL DC107
FDA 510(k)
FDA Class 2
·Clinical Toxicology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 15, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 7, 2010
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 6, 2012
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·October 17, 2012
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code KWQ·August 30, 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