12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 26, 2025
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·June 2, 2025
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052016074·Oval Burr 6,5
ARTHREX HUMERAL FRACTURE PLATES AND SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
VUSION(R) OS
FDA 510(k)
FDA Class 2
·Orthopedic
ZOLL IVTM COOL LINE CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·June 3, 2021
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 28, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024