15 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Polaris Valve Electronic Reading Instrument
FDA 510(k)
FDA Class 2
·Neurology
HEALIX ADVANCE
FDA UDI
Medos International Sàrl·10886705030576·HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR TCP/PLLA ...
Ambassador Cervical Plate System
FDA UDI
Choice Spine, LP·00840996160940·AMBASSADOR,DRILL,2.4X22
PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Arietta 65
FDA 510(k)
FDA Class 2
·Radiology
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 11, 2019
TRAUMA TRANSTAR
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·July 14, 2011
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 5, 2008
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 12, 2013
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 3, 2026
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 22, 2022
PERITX DRAINAGE BAG KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·December 18, 2025
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 11, 2026
4.9MM HEALX ADV SP BIOC ANCHOR
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code MAI·October 20, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025