9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V-varnish Premium
FDA 510(k)
FDA Class 2
·Dental
Monza Cervical Plate System
FDA UDI
Altus Spine, LLC·B41711603771·77mm Cervical Plate, 3 Level
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221045270·Unitek(TM) Molar Band General Purpose Wide Regu...
DIAMONDBACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DR DISPOSABLE PROPHY ANGLE MODEL H310
FDA 510(k)
FDA Class 1
·Dental
SOVEREIGN SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·July 13, 2011
ATTAIN CS
FDA Adverse Event
Injury
·MPRI·Product code LWP·June 10, 2013
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·September 16, 2008
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021