12 results
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28ms
·
Sources: EU EUDAMED, US FDA
RayStation (2024A SP3)
FDA 510(k)
FDA Class 2
·Radiology
COR
FDA UDI
Medos International Sàrl·10886705012374·COR Disposable Kit, 8mm
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112786·BARRON VACUUM PUNCH 8.25MM
TMS SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036083885·
HD-Camera HDC1000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES)
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Exactech, Inc.·10885862523969·TRIAL, TIBIAL INSERT, SPACER, SIZE 1, SIZE 1.5,...
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011
DELTAPAQ - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MICRUS ENDOVASCULAR, LLC·Product code HCG·July 29, 2013
COR Disposable Kit, 8 mm. Cartilage Transplant System.
FDA Enforcement
Class II
·Ongoing·DePuy Mitek, Inc., a Johnson & Johnson Co.·March 19, 2025
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
FDA Enforcement
Class II
·Ongoing·DePuy Mitek, Inc., a Johnson & Johnson Co.·March 19, 2025