10 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRIMUS Healthcare Sterilizer (Model PSS11-HC)
FDA 510(k)
FDA Class 2
·General Hospital
BD CONNECTA¿ STOPCOCK WITH EXTENSION SET
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·September 8, 2023
BD CONNECTA¿ STOPCOCK WITH EXTENSION SET
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·September 8, 2023
Kleiner KG2 System
FDA 510(k)
FDA Class 2
·Orthopedic
DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GLIDEWELL HT IMPLANT Ø7.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 1, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 3, 2014
EXPORTAP
FDA Adverse Event
Malfunction
·MEDTRONIC INC.·Product code DXE·August 17, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 3, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024