20 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID
FDA 510(k)
FDA Class 2
·Dental
Globe Scientific
FDA UDI
GLOBE SCIENTIFIC INC.·00840095620253·Pipette tip, 1-200uL, natural for Oxford Slimline
AGC TRADITION KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304241268·
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575304394·Orthopaedic implant inserter/extractor, reusabl...
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575304387·Orthopaedic implant inserter/extractor, reusabl...
Trulink
FDA UDI
Statcorp Medical·10841522123399·BP CUFF,TL VINYL,1T,ADULT,26-35CM,5/BG
Statcorp Medical
FDA UDI
Statcorp Medical·10841522104473·BP CUFF,TL VINYL,1T,ADULT,26-35CM,EA
HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34
FDA 510(k)
FDA Class 2
·Physical Medicine
ANGIODYNAMICS TUMESCENT INFUSION DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
ANTI-HUMAN GLOBULIN ANTI-IGG,-C3D POLYSPECIFIC (RABBIT) MTS¿ ANTI-IGG,-C3D CARD
FDA Adverse Event
Malfunction
·MICROTYPING SYSTEMS·Product code KSZ·August 12, 2019
COBAS 8000 COBAS ISE MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·October 2, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 13, 2016
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
PASSIVE PLUS DX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·June 21, 2011
ANTI-HUMAN GLOBULIN ANTI-IGG,-C3D POLYSPECIFIC (RABBIT) MTS¿ ANTI-IGG,-C3D CARD
FDA Adverse Event
Malfunction
·MICROTYPING SYSTEMS·Product code KSZ·August 12, 2019
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016
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