68 results · 24ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)
FDA Class 2 ·Microbiology

MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Clear Aligner

FDA 510(k)
FDA Class 2 ·Dental

COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

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

COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

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

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·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 PING METER

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

COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

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

COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

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

COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

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

COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

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

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

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

COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

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

COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

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

COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

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

COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

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