8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLEXPOSURE RETRACTOR
FDA 510(k)
FDA Class 2
·Orthopedic
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983144·posteriors; shade BL3; size XL; upper jaw
ACUMED CLAVICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
uMC 560i
FDA 510(k)
FDA Class 2
·Radiology
OMEGA¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·February 28, 2013
ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL)
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code GMS·January 17, 2011
PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024