16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tubing Pack
FDA 510(k)
FDA Class 2
·Cardiovascular
INTEGRAL X-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304650374·
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383552431·Gutta Percha Points is used to root canal filin...
InFill Anatomic ACF
FDA UDI
PINNACLE SPINE GROUP, LLC·00814729025691·
InFill Lordotic ACF
FDA UDI
PINNACLE SPINE GROUP, LLC·00814729025578·
BD LOGIC BLOOD GLUCOSE MONITOR
FDA Adverse Event
Other
·BECTON DICKINSON·Product code NBW·March 15, 2005
ZYTO HAND CRADLE
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
M2A-MAGNUM TAPER INSERT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 10, 2017
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 14, 2014
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·July 15, 2011
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·September 22, 2008
KIT BD MAX EXT ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·June 21, 2022
ESOPHYX Z
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 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