20 results · 26ms · 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.

AmplifEYE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

IMC SURGICAL FACE MASK

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

THERAPEUTIC MASSAGE COMPANION

FDA 510(k)
FDA Class 2 ·Neurology

COMFORT TOUCH INSUIN PEN NEEDLES

FDA Adverse Event
Malfunction ·JIANGSU CAINA TECHNOLOGY CO., LTD.·Product code FMI·May 21, 2021

ARTERIAL PRESSURE MONITORING TRAY

FDA Adverse Event
Malfunction ·COOK INC·Product code DQO·December 3, 2024

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

RHEUMATOID FACTOR TEST SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code DHR·July 13, 2011

VIVA QUAD XT

FDA Adverse Event
Malfunction ·IPG MFG SWITZERLAND·Product code NIK·October 10, 2014

DENALI JUGULAR SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 27, 2023

DENALI JUGULAR SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 21, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 10, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023

DENALI JUGULAR SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 26, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 6, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 11, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 7, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 20, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 9, 2023

Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020