7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CUFFCHECK
FDA 510(k)
FDA Class 2
·Anesthesiology
OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
S-mini active Fixture
FDA 510(k)
FDA Class 2
·Dental
CURRENT RF VR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
TRIDENT HEMISPHERICAL SOLID BK 52MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·October 20, 2010
HELIX-T ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code KWQ·November 15, 2012
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·October 19, 2016