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