16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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