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

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Abutment for Bridges

FDA 510(k)
FDA Class 2 ·Dental

Bernafon

FDA UDI
Bernafon AG·05711584055175·MI5 CPx, VC PS BE MIRUM 5

CONELOG IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

CP RELIEF WAND

FDA 510(k)
FDA Class 2 ·Neurology

OCTRODE LEAD KIT, 60CM LENGTH

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code LGW·September 23, 2024

PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

CAPSUREFIX NOVUS

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

COLLEAGUE PRE 1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 8, 2011

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

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

Artis zee biplane, Model Number 10094141

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

ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; 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 ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

Artis zee/ zeego systems; 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·August 26, 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

Siemens Artis zee systems; 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·August 12, 2015