14 results · 21ms · Sources: EU EUDAMED, US FDA

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EDS Universal Cement

FDA 510(k)
FDA Class 2 ·Dental

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100615·KATENA DOUBLE-X SPECULUM K-WIRE

BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES

FDA 510(k)
FDA Class 2 ·Cardiovascular

APOLLO GENERATOR

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code GWG·June 11, 2015

SYRINGE 30ML LL BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·January 27, 2025

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 8, 2014

SPRINT QUATTRO SECURE S

FDA Adverse Event
Injury ·MPRI·Product code LWS·June 7, 2013

STENOSCOP

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011

BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·March 13, 2018

BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 3, 2018

BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·May 22, 2018

ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

FDA Enforcement
Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019