12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
FDA 510(k)
FDA Class 2
·Radiology
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100332601·IN-OVATION® C Roncone 022 UL/3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100332101·IN-OVATION® C Base Rx 022 UL/3-3 CS HK
CLEARCANVAS RIS / PACS
FDA 510(k)
FDA Class 2
·Radiology
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 27, 2018
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 20, 2011
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 14, 2013
FERNO MODEL 35X PROFLEXX AMBULANCE STRETCHER
FDA Adverse Event
Malfunction
·FERNO-WASHINGTON, INC.·Product code FPO·September 12, 2008
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024