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TRAUMA IMPLANT

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MDM·March 28, 2019

NA

FDA UDI
NT-Trading GmbH & Co. KG·ENTTW11EFK0001·Screwdriver

TC PRIM FIXED FEM COMP TC PS RIGHT 8 CEM

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS AG·Product code JWH·September 4, 2020

Forceps, Articulation Paper

FDA classification
FDA Class 1 ·Forceps, Articulation Paper

REALLOY E.K.

FDA registration
REALLOY E.K.·1 product·🇩🇪 Germany

PANTRAK E.K.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EKF Life Sciences

FDA registration
EKF Life Sciences·3 products·🇺🇸 United States

EKF DIAGNOSTIC GMBH

FDA registration
EKF DIAGNOSTIC GMBH·4 products·🇩🇪 Germany

MeKo Manufacturing e.K.

FDA registration
MeKo Manufacturing e.K.·1 product·🇩🇪 Germany

PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J +6 mm TB; Right Size 1-2 CD +0 mm TB; Right Size CD +6 mm TB; Right Size EF +0 mm TB; Right Size EF +6 mm TB; Right Size GH +0 mm TB; Right Size GH +6 mm TB; Right Size J +0 mm TB; and Right Size J +6 mm TB.

FDA Recall
Terminated ·Zimmer, Inc.·Product code JWH·August 7, 2014

Add Pack Hemo Control DM

FDA UDI
EKF-diagnostic GmbH·04048534002189·For the quantitative determination of hemoglobi...

DiaSpect Tm

FDA UDI
EKF-diagnostic GmbH·04048534001946·For the quantitative determination of hemoglobi...

DiaSpect Tm

FDA UDI
EKF-diagnostic GmbH·04048534002165·For the quantitative determination of hemoglobi...

Hemo Control

FDA UDI
EKF-diagnostic GmbH·04048534002028·For the quantitative determination of hemoglobi...

Hemo Control Hemoglobin Microcuvette

FDA UDI
EKF-diagnostic GmbH·04048534000031·For the quantitative determination of hemoglobi...

DiaSpect Control HBT1

FDA UDI
EKF-diagnostic GmbH·14048534001974·For the verification of the precision and accur...

DiaSpect Tm Cuvettes

FDA UDI
EKF-diagnostic GmbH·14048534001967·For the quantitative determination of hemoglobi...

DiaSpect Control HBT4

FDA UDI
EKF-diagnostic GmbH·04048534002004·For the verification of the precision and accur...

Cleaner

FDA UDI
EKF-diagnostic GmbH·04048534000840·For Cleaning the optical unit of Hemo Control A...

DiaSpect Control HBT2

FDA UDI
EKF-diagnostic GmbH·14048534001981·For the verification of the precision and accur...