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

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TriALTIS™ Spine System

FDA 510(k)
FDA Class 2 ·Orthopedic

ULTRABLOX

FDA 510(k)
FDA Class 2 ·Radiology

Neurosign V4 Intraoperative Nerve Monitor

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DTK·July 29, 2025

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FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·November 12, 2024

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013

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FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·May 20, 2026

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FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·April 20, 2026

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FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·March 20, 2026

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FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·April 22, 2026

UNKNOWN

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DTK·January 9, 2025

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FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DTK·March 20, 2026

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FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·May 12, 2026

UNKNOWN

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DTK·September 12, 2024

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FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DTK·December 8, 2025

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FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·August 12, 2025

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FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DTK·September 11, 2025

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FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·October 25, 2024