8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CADD® Infusion Disposables Portfolio with NRFit connectors
FDA 510(k)
FDA Class 2
·General Hospital
REACH(R) FEMORAL PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304307070·
PRODRIVE SYSTEMS REPLACEMENT TURBINE
FDA 510(k)
FDA Class 1
·Dental
SOCORRO SMI TUNNEL RELEASE DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·July 7, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 11, 2013
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·September 16, 2008
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024