21 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PALACOS MV
FDA 510(k)
FDA Class 2
·Orthopedic
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741822600·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674182260060·
PROPELLER HEAD SCREW SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304269811·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1822600·18mm H x 22mm W x 60mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L1822600·18mm H x 22mm W x 60mm L Lateral Implant Trial ...
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100974·DESMARRES LID RETRACTOR #2
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L182260120·18mm H x 22mm W x 60mm L XLIF Trial 12 degree L...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X18226080·18mm H x 22mm W x 60mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X182260120·18mm H x 22mm W x 60mm L x 12 degrees XLIF
BD MAX¿ STAPHSR
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code NQX·February 16, 2023
FDI GLUCOSE CONTROL SOLUTIONS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES
FDA 510(k)
FDA Class 2
·Orthopedic
RADIESSE VOICE
FDA Adverse Event
Injury
·BIOFORM MEDICAL·Product code LMH·January 30, 2009
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 21, 2013
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2011
LEAD MODEL UNKNOWN
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·October 17, 2014
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 27, 2019
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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