10 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TAPERSET HIP SMALL STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
Kerrison
FDA UDI
ELLIQUENCE, LLC·00846338004781·
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
TI-BASE ABUTMENT, 1 CONNECT ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
TITAN RES ECLD 75CC
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·October 30, 2018
GENESYS HTA PROCERVA®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·May 21, 2013
TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
FDA Adverse Event
Other
·CARIDIANBCT·Product code LKN·June 1, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 13, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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