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Phoenix Key Tie

FDA UDI
PHOENIX ORTHODONTICS INC·05060772893847·KEY TIE LIGHT BLUE PK1000

DJO SURGICAL

FDA Adverse Event
Injury ·ENCORE MEDICAL L.P.·Product code KWS·April 15, 2025

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·June 17, 2020

ADVIA CHEMISTRY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code KLB·April 17, 2024

TOBR2 TOBRAMYCIN

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code KLB·April 14, 2017

Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190. (Note: Not distributed within the United States.)

FDA Recall
Terminated ·Roche Diagnostics Corp.·Product code KLB·April 5, 2007

Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog No. 04642511190. (Note: Not distributed within the United States)

FDA Recall
Terminated ·Roche Diagnostics Corp.·Product code KLB·April 5, 2007

Radioimmunoassay, Tobramycin

FDA classification
FDA Class 2 ·Radioimmunoassay, Tobramycin

KBL GmbH

FDA registration
KBL GmbH·2 products·🇩🇪 Germany

Alconox

FDA UDI
ALCONOX INC·00660483111114·Cleaner for ultrasonic cleaning of medical devices

ORTHO. MALLET 2 LB/ 1 LB

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code HXL·June 21, 2021

ORTHO. MALLET 2 LB/ 1 LB

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code HXL·June 21, 2021

ORTHO. MALLET 2 LB/ 1 LB

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code HXL·December 29, 2020

ORTHO. MALLET 2 LB/ 1 LB

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code HXL·December 11, 2020

ORTHO. MALLET 3 LB / 2 LB

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code HXL·August 19, 2020

ORTHO. MALLET 2 LB/ 1 LB

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code HXL·October 4, 2021

ORTHO. MALLET 2 LB/ 1 LB

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code HXL·August 19, 2021

ORTHO. MALLET 2 LB/ 1 LB

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code HXL·August 11, 2021

ORTHO. MALLET 2 LB/ 1 LB

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code HXL·January 22, 2020

ORTHO. MALLET 2 LB/ 1 LB

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code HXL·January 6, 2020