33 results · 21ms · Sources: EU EUDAMED, 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