9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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iNSitu Total Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
Sentinel
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522125805·SENTINEL 11 RDT TEST SYSTEM
SENTINEL
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129414·SENTINEL 11 RDT TEST SYSTEM
AEI DR. TERAUCHI ULTRASONIC TIPS
FDA 510(k)
FDA Class 2
·Dental
VENUS PEARL PLT REFILL A1
FDA 510(k)
FDA Class 2
·Dental
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 17, 2013
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·June 24, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 19, 2008
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021