27 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
FDA 510(k)
FDA Class 2
·Hematology
Oticon
FDA UDI
Oticon A/S·05707131165381·K140, ITC/ITE AP BE
ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
M2376A DEVICELINK SYSTEM, MODEL M2376A
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 1, 2024
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·May 5, 2023
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·December 6, 2023
FOLEY CATHETER
FDA Adverse Event
Malfunction
·PRODUCTOS PARA EL CUIDADO DE LA SALUD·Product code EZL·May 3, 2013
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·August 26, 2014
6600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 11, 2011
M2A-MAGNUM 42-50MM TPR INSRT-3
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2013
M2A-MAGNUM MOD HD SZ 50MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2013
M2A-MAGNUM PF CUP 56ODX50ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2013
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·September 22, 2025
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·September 22, 2025
IMMULITE® 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·December 11, 2024
IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT (SPE)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·October 1, 2022
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016