27 results · 23ms · Sources: EU EUDAMED, 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