13 results · 21ms · Sources: EU EUDAMED, US FDA

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BIMETRIC TOTAL HIP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BI-METRIC HIP LATERALISED FEMORAL STEM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·March 2, 2017

De Soutter Medical

FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123106·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 100mm

GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ENDOCERVICAL BLOCK NEEDLE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

IOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021

SPRINT

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code LWS·December 13, 2010

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 17, 2013

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
UNKNOWN·Product code ITJ·July 9, 2014

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