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

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Bard Mission Disposable Core Biopsy Instrument

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

RTX3370

FDA 510(k)
FDA Class 2 ·Cardiovascular

SMDIA-1000

FDA 510(k)
FDA Class 2 ·Anesthesiology

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 7, 2013

ALBUMIN (HUMAN) 25%, USP PLASBUMIN-25

FDA Adverse Event
Malfunction ·TALECRIS BIOTHERAPEUTICS, INC.·Product code KPE·July 18, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 19, 2008

FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System

FDA Recall
Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·February 13, 2023

CAPTURA HOT BIOPSY FORCEPS

FDA Adverse Event
Injury ·WILSON-COOK MEDICAL INC·Product code KGE·December 2, 2024

FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System

FDA Enforcement
Class I ·Ongoing·Abbott Diabetes Care, Inc.·April 12, 2023

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·July 15, 2024

CONQUEST PRO 12 ST

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·July 16, 2025

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·June 29, 2020

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·June 14, 2024

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·August 19, 2021

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·May 15, 2023

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·February 14, 2023

ASTATO XS 9-12

FDA Adverse Event
Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·June 24, 2025

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 7, 2023

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·January 27, 2022

Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021