15 results · 22ms · Sources: EU EUDAMED, 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