18 results
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39ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ROCC Console
FDA 510(k)
FDA Class 2
·Radiology
LCP
FDA UDI
Synthes GmbH·10886982168719·2.4MM LCP® DISTAL RADIUS L-PLATE/-20 DEG 3H HD/...
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071152758·24F x 2.5cm MiniSPC Low Profile Suprapubic Cath...
EXT SET 15CM LUER-LOK POWER INJECTABLE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·February 8, 2019
BD EXT SET 15CM LUER-LOK¿ POWER INJECTABLE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·February 8, 2019
EXT SET 15CM LUER-LOK POWER INJECTABLE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·February 13, 2019
BD EXT SET 15CM LUER-LOK¿ POWER INJECTABLE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·February 8, 2019
EXT SET 15CM LUER-LOK POWER INJECTABLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·February 13, 2019
Personalized Physiology Analytics Engine software
FDA 510(k)
FDA Class 2
·Cardiovascular
VECTORVISION ACL
FDA 510(k)
FDA Class 2
·Neurology
EXT SET 15CM LUER-LOK POWER INJECTABLE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·February 13, 2019
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
ALARIS INFUSION SYSTEM
FDA Adverse Event
Other
·CARDINAL HEALTH ALARIS RPODUCTS·Product code FRN·November 21, 2008
FLEXCATH STEERABLE SHEATH
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code DRA·July 23, 2013
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
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
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