11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LINK Instruments - Rasps, compressors and broaches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575286591·Orthopaedic prosthesis instrument, reusable - G...
LINK Instruments - Rasps, compressors and broaches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575286355·Orthopaedic prosthesis instrument, reusable - G...
HYPO CLENZ WOUND WASH MODEL 100 PPM
FDA 510(k)
FDA Unclassified
·Unknown
VMATE MODEL VMM1000
FDA 510(k)
FDA Class 2
·Ophthalmic
OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 13MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·September 29, 2025
RADIOLUCENT HOHMANN RETRACTOR W/35 L275
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code GAD·May 24, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 30, 2014
CONTOUR¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FAD·June 16, 2011
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
FDA Enforcement
Class I
·Ongoing·Edwards Lifesciences, LLC·July 16, 2025
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020