22 results · 27ms · Sources: EU EUDAMED, US FDA

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Corin TriFit TS Hip

FDA 510(k)
FDA Class 2 ·Orthopedic

VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)

FDA 510(k)
FDA Class 1 ·General Hospital

HPR EMOLLIENT FOAM

FDA 510(k)
FDA Unclassified ·Unknown

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 8, 2014

SPRINT QUATTRO SECURE S

FDA Adverse Event
Injury ·MPRI·Product code LWS·June 8, 2013

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·July 8, 2011

GMK SPHERE TIBIAL INSERT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2017

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code KRD·November 6, 2020

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code KRD·November 6, 2020

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code KRD·November 6, 2020

NESTER PLATINUM EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·June 14, 2020

NESTER PLATINUM EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·February 19, 2020

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 15, 2023

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 9, 2023

Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

Artis zee biplane, Model Number 10094141

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

Artis zee biplane, Model Number 10094141

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

Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 1, 2015

The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014