8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOTRAK SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122833·K-WIRE - DOUBLE TROCAR 0.8mm DIA x 75mm
4.5F IMAGECATH ANGIOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY
FDA 510(k)
FDA Class 2
·Hematology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 22, 2013
SIGMA 200 DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·December 14, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024