17 results · 22ms · Sources: EU EUDAMED, US FDA

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Surefire Infusion System

FDA 510(k)
FDA Class 2 ·Cardiovascular

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017866·K-Wire, Double Ended, Trocar Point, Diameter Si...

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017873·K-Wire, Double Ended, Trocar Point, Diameter 0....

FEMVUE CORNUAL BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ADAPTIVE WEDGE

FDA 510(k)
FDA Class 2 ·Orthopedic

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 22, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 16, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 29, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·October 10, 2014

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013

TPS CONSOLE

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HWE·June 30, 2011

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FDA Adverse Event
Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 22, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 27, 2020

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 9, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 2, 2021

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024