15 results
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18ms
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Sources: EU EUDAMED, US FDA
TRUSCULPT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NAVIGATOR APPLICATIONS SUITE
FDA 510(k)
FDA Class 2
·Anesthesiology
READI-LOAD SYSTEM, MODEL PSS 1820RL
FDA 510(k)
FDA Class 2
·Radiology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970515·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970522·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973127·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973554·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973011·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970539·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973417·
BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 1, 2020
ULTRA MATTRESS ASSY 4 X 26
FDA Adverse Event
Injury
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 21, 2013
LC BEAD M1
FDA Adverse Event
Injury
·/BIOCOMPATIBLES U.K. LIMITED·Product code HCG·September 18, 2014
ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·June 13, 2011
Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·January 24, 2018