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

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AirLife Adult Heated Wire Circuit

FDA 510(k)
FDA Class 2 ·Anesthesiology

SBH

FDA UDI
SBH Surgical·00850068304011·1/1, Sterilization Container Perforated Lid, Bl...

I-STAT EC8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 9, 2017

LINK Instruments - Trial implants and size gauges

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575363971·Knee femur prosthesis trial - Endo Model Knee S...

LINK Instruments - Trial implants and size gauges

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575363995·Knee femur prosthesis trial - Endo Model Knee S...

LINK Instruments - Trial implants and size gauges

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575364008·Knee femur prosthesis trial - Endo Model Knee S...

LINK Instruments - Trial implants and size gauges

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575363964·Knee femur prosthesis trial - Endo Model Knee S...

LINK Instruments - Trial implants and size gauges

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575364015·Knee femur prosthesis trial - Endo Model Knee S...

LINK Instruments - Trial implants and size gauges

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575363988·Knee femur prosthesis trial - Endo Model Knee S...

GC AADVA BO AC ABUTMENTS

FDA 510(k)
FDA Class 2 ·Dental

PM-9000 EXPRESS PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

SPRINT QUATTRO

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

ENDURANT STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·June 23, 2011

ACCU-CHEK MULTICLIX

FDA Adverse Event
Injury ·ROCHE DIAGNOSTICS·Product code FMK·September 4, 2008

M.U.S.T. PEDICLE SCREW 7X45

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MNI·January 20, 2017

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

Allura Xper FD20/15; Catalog numbers: 722058

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Artis zee biplane, Model Number 10094141

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

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 9, 2014