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NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EGS·October 24, 2016

RBI2 SUCTION RECTAL BIOPSY SYSTEM

FDA Adverse Event
Malfunction ·AUS SYSTEMS PTY LTD·Product code FCK·May 17, 2025

PROCEDURE PACK (CUTTER)

FDA Adverse Event
Malfunction ·AUS SYSTEMS PTY LTD·Product code FCK·January 26, 2024

RBI2 SUCTION RECTAL BIOPSY SYSTEM

FDA Adverse Event
Malfunction ·AUS SYSTEMS PTY. LIMITED.·Product code FCK·November 18, 2024

RBI2 SUCTION RECTAL BIOPSY SYSTEM

FDA Adverse Event
Malfunction ·AUS SYSTEMS PTY. LIMITED.·Product code FCK·November 12, 2024

RBI2 SUCTION RECTAL BIOPSY SYSTEM

FDA Adverse Event
Malfunction ·AUS SYSTEMS PTY. LIMITED.·Product code FCK·November 18, 2024

RBI2 SUCTION RECTAL BIOPSY SYSTEM

FDA Adverse Event
Malfunction ·AUS SYSTEMS PTY LTD·Product code FCK·December 14, 2024

RBI2 SUCTION RECTAL BIOPSY SYSTEM

FDA Adverse Event
Malfunction ·AUS SYSTEMS PTY LTD·Product code FCK·December 14, 2024

RBI2 SUCTION RECTAL BIOPSY SYSTEM

FDA Adverse Event
Malfunction ·AUS SYSTEMS PTY LTD·Product code FCK·December 13, 2024

RBI2

FDA Adverse Event
Injury ·Product code FCK·August 2, 2016

RBI2

FDA Adverse Event
Injury ·Product code FCK·July 19, 2017

SENORX ENCORE MRI TROCAR TIP PROBE

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR INC·Product code FCK·December 28, 2015

RBI2

FDA Adverse Event
Injury ·Product code FCK·November 16, 2015

RB12 SUCTION RECTAL BIOPSY MANOMETER

FDA Adverse Event
Injury ·AUS SYSTEMS PTY LTD.·Product code FCK·February 23, 2022

RBIZ SUCTION RECTAL BIOPSY MANOMETER

FDA Adverse Event
Injury ·AUS SYSTEMS PTY LTD.·Product code FCK·January 18, 2022

RBI2 SUCTION RECTAL BIOPSY SYSTEM

FDA Adverse Event
Injury ·AUS SYSTEMS PTY LTD·Product code FCK·March 2, 2022

The EnCor biopsy probe, designed for use with EnCor and EnCor Enspire Vacuum Assisted Biopsy (VAB) driver systems. The EnCor Biopsy Device is indicated for use in acquiring tissue for diagnosing breast abnormalities and is supplied sterile and intended for single use.

FDA Recall
Terminated ·Bard Peripheral Vascular Inc·Product code FCK·November 3, 2011

Instrument, Biopsy, Suction

FDA classification
FDA Class 2 ·Instrument, Biopsy, Suction

FCI SUD

FDA registration
FCI SUD·29 products·🇲🇺 Mauritius

FCI SAS

FDA registration
FCI SAS·30 products·🇫🇷 France