10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vertex Hip Fracture Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Spoon
FDA UDI
KATENA PRODUCTS, INC.·00841668103425·LOOP FOR NUCLEUS DIVIDER PACK OF 3
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981041922·39x30mm Trial Rasp 10mm 8 deg
OLYMPUS URINE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NORDICBRAINEX
FDA 510(k)
FDA Class 2
·Radiology
ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·November 19, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 6, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
PN 31X5 EUROPE BD BRAND
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·September 29, 2020
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025