17 results · 19ms · 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.

SPECTACLE FRAME

FDA 510(k)
FDA Class 1 ·Ophthalmic

3M™ ESPE™

FDA UDI
3M COMPANY·30605861030695·3M™ ESPE™ Gold Anodized Crown Refills, First Mo...

N/A

FDA UDI
Tyber Medical, LLC·M695M9403260·

AUTOQUANT PLUS

FDA 510(k)
FDA Class 2 ·Radiology

XGEO GF50

FDA 510(k)
FDA Class 2 ·Radiology

LIBERTY CYCLER

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·June 19, 2014

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code BTI·February 2, 2013

ADVANTAGE SERIES 26

FDA Adverse Event
Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 9, 2010

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020

TVT EXACT RETROPUBIC SYSTEM

FDA Adverse Event
Malfunction ·ETHICON INC.·Product code OTN·April 1, 2022

BD TRUCOUNT¿ TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025

Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

FDA Enforcement
Class II ·Terminated·Cook Inc.·May 16, 2018

Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

FDA Enforcement
Class II ·Terminated·Capintec Inc·April 1, 2020