13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761975972·Trumpf Medical/Medizin Pad TTS Carbon 600 G
Pads
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761968912·Pad TTS Carbon 600 G
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 31, 2022
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
FDA 510(k)
FDA Class 1
·Microbiology
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
LINEAR 3-4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 29, 2024
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·April 24, 2013
DA VINCI SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·May 6, 2011
DISPOSABLE HANDSW PENCIL
FDA Adverse Event
Injury
·COVIDIEN LP (VALLEYLAB)·Product code GEI·July 21, 2008
RUNTHROUGH NS
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 24, 2018
RUNTHROUGH NS
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 30, 2018
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014