10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Gamma4 System
FDA 510(k)
FDA Class 2
·Orthopedic
Sonic
FDA UDI
Sonic Innovations, Inc.·05714464010899·SONIC RADIANT 60 MNR T R DG
HEALIX ADVANCE ORTHOCORD
FDA UDI
Medos International Sàrl·10886705021444·HEALIX ADVANCE PEEK ANCHOR w/ORTHOCORD PEEK Anc...
STRYKER POWERED WHEELED STRETCHER
FDA 510(k)
FDA Class 2
·Physical Medicine
Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
PRECISION SPECTRA®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 4, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 12, 2013
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025