8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PANORAMIC X-RAY MODEL PC-1000
FDA 510(k)
FDA Class 2
·Dental
SBI LATERAL RADIO CAPITELLUM
FDA 510(k)
FDA Class 2
·Orthopedic
Dental Low-speed Turbine Handpiece
FDA 510(k)
FDA Class 1
·Dental
VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·June 12, 2014
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 11, 2010
SCREW
FDA Adverse Event
Injury
·Product code HWC·December 12, 2012
B125P Patient Monitor (with E-module slot option), REF 6160000-002
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024