14 results · 30ms · Sources: EU EUDAMED, US FDA

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CancelleX Porous Titanium Lumbar Interbody Device

FDA 510(k)
FDA Class 2 ·Orthopedic

FUKUSHIMA SUCTION TUBE

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896009660·FUKUSHIMA SUCTION TUBE

FUKUSHIMA SUCTION TUBE

FDA UDI
SONTEC INSTRUMENTS, INC.·B0991803730·FUKUSHIMA SUCTION TUBE

TACAHE PC1350 POWER WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

TYCHE PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

FOLFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 17, 2014

SURFLO I.V. CATHETER

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code FOZ·June 20, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 27, 2011

EVOLUT FX DCS

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 18, 2025

Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022

Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600

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

Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022