26 results · 27ms · Sources: EU EUDAMED, US FDA

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TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001

FDA 510(k)
FDA Class 2 ·Radiology

CARDINAL HEALTH

FDA UDI
Cardinal Health 200, LLC·10885380077357·1.1mm Non-Threaded Guide Wire 150mm

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089448890·

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122223·KWire .045x6" (1.1x150mm)

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213033412·Coupling Treatment Tube for 4F Flexibles (8)

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122216·KWire .045x6" (1.1x150mm) Threaded

CM TITAMAX EX IMPLANT 3.75X15

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·November 8, 2017

MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235

FDA 510(k)
FDA Class 2 ·Radiology

CD HORIZON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 13, 2026

LINEAR? ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 29, 2025

SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018

CD HORIZON

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·March 15, 2017

IMMULITE 2000 XPI

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJQ·May 14, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

UNKNOWN DEPUY ASR HIP

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011

Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

Artis Q.zen ceiling, Model Number 10848354

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

Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Angiography systems developed for single and biplane diagnostic imaging

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 8, 2021

Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012