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