33 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Proton Positioing and Immobilization Devices
FDA 510(k)
FDA Class 2
·Radiology
BALANCE HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304268715·
ILO
FDA UDI
ILO electronic GmbH·04250369707348·300W xenon light source
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690110552·Threaded Steinman Pin
Jig
FDA UDI
I.T.S. GmbH·09120047297056·Jig, Right, Proximal Lateral Tibia Plate
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 30, 2024
8.0MHZ PENCIL PROBE 841-A
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787020847·
DASH HIP
FDA 510(k)
FDA Class 2
·Neurology
PHILIPS HERCEPTEST DIGITAL SCORE
FDA 510(k)
FDA Class 2
·Hematology
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of 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·November 11, 2020
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 27, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 20, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
GOODBABY·Product code IOR·October 17, 2014
SMALL SUPERIOR AUGMENT GLENOID PLATE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·June 27, 2024
OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025
OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025
Disposable Injection Needles
FDA UDI
Ningbo Xinwell Medical Technology Co., Ltd.·06942067959317·Disposable Injection Needles
Disposable Injection Needles
FDA UDI
Ningbo Xinwell Medical Technology Co., Ltd.·06942067960085·Disposable Injection Needles
Disposable Injection Needles
FDA UDI
Ningbo Xinwell Medical Technology Co., Ltd.·06942067959355·Disposable Injection Needles
Disposable Injection Needles
FDA UDI
Ningbo Xinwell Medical Technology Co., Ltd.·06942067959324·Disposable Injection Needles