14 results
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26ms
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Sources: EU EUDAMED, US FDA
MR5 Activ Pro
FDA 510(k)
FDA Class 2
·Physical Medicine
Pelotte Plus Evacuation Tip
FDA UDI
HAGER WORLDWIDE, INC.·00014081540249·4" plastic dental aspirator tip (green)
Pelotte Plus Evacuation Tip
FDA UDI
HAGER WORLDWIDE, INC.·D2482540241·4" plastic dental aspirator tip (green)
ALTIVO™ Anterior Cervical Fixation System
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030FCP12540240·Drill, 3mm, 24mm
Phantom
FDA UDI
Innovative Med·00851314007038·Surgical Aspirator:1/3 hp. 0-3.6 scfm / 0-27.5 ...
HWJECT Auto-disable syringe
FDA 510(k)
FDA Class 2
·General Hospital
SOFIA 88 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
FINELINE II
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·November 11, 2008
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·August 11, 2011
REPLY
FDA Adverse Event
Injury
·SORIN GROUP ITALIA S.R.L.·Product code NVZ·July 26, 2013
ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·March 2, 2017
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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