9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ziehm Vision FD
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668101193·FUKASAKU 'HOCKEY' KNIFE
Cascadia™ Interbody System
FDA UDI
VB Spine LLC·10888857369740·Trial, Size 12x14x8 mm, 15°
Brainsway Deep TMS System
FDA 510(k)
FDA Class 2
·Neurology
Digital Automatic Blood Pressure Monitor MD2300
FDA 510(k)
FDA Class 2
·Cardiovascular
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·July 29, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 11, 2014
RESTORATION ADM X3 INS 28/52
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025