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

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Laser Helmet LH40-EVO

FDA 510(k)
FDA Class 2 ·Physical Medicine

OsteoMed

FDA UDI
OSTEOMED LLC·00845694036191·Cannulated Depth Gauge, Double-Sided, Fusion

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523104000·T³ Acetabular Hemispherical Shell, Cluster Hole...

STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001

FDA 510(k)
FDA Class 2 ·Cardiovascular

ELECTRONIC GAS BLENDER

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·November 19, 2025

STOCKERT S3 GAS BLENDER

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 22, 2014

ENRHYTHM DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·October 10, 2014

OT VERIO IQ METER

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

UNICEL DXC 600I SYNCHRON SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JGS·June 17, 2011

S3 GAS BLENDER SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017

S3 GAS BLENDER SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017

S3 ELECTRONIC GAS BLENDER

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·December 19, 2024

SORIN S3 GAS BLENDER

FDA Adverse Event
Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTX·February 25, 2015

Artis zeego, Model Number 10280959

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020