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BX53 FRAME

FDA Adverse Event
Malfunction ·EVIDENT CORPORATION·Product code IBJ·July 22, 2022

BX53 FRAME

FDA Adverse Event
Malfunction ·OLYMPUS CORPORATION·Product code IBJ·February 20, 2020

BX53 FRAME

FDA Adverse Event
Malfunction ·EVIDENT CORPORATION·Product code IBJ·October 24, 2022

BX53 FRAME

FDA Adverse Event
Malfunction ·OLYMPUS CORPORATION·Product code IBJ·February 20, 2020

Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.

FDA Recall
Terminated ·Zeiss, Carl Inc·Product code IBJ·December 20, 2013

Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.

FDA Recall
Terminated ·Zeiss, Carl Inc·Product code IBJ·May 28, 2013

Light, Microscope

FDA classification
FDA Class 1 ·Light, Microscope

IBA Dosimetry GmbH

FDA registration
IBA Dosimetry GmbH·6 products·🇩🇪 Germany

IBA Dosimetry America

FDA registration
IBA Dosimetry America·1 product·🇺🇸 United States

IBE ELECTRONICS CO., LTD

FDA registration
IBE ELECTRONICS CO., LTD·2 products·🇨🇳 China

CD38-APC (Clone IB6)

FDA UDI
Miltenyi Biotec B.V. & Co. KG·04049934134210·IB6 recognizes the human CD38 antigen, a single...

OLYMPUS WINTER & IBE GMBH

FDA registration
OLYMPUS WINTER & IBE GMBH·93 products·🇩🇪 Germany

Olympus Winter & Ibe GmbH

FDA registration
Olympus Winter & Ibe GmbH·8 products·🇩🇪 Germany

IBD Medical Trading Pty Ltd.

FDA registration
IBD Medical Trading Pty Ltd.·5 products·🇦🇺 Australia

eCarbon IBDs

FDA 510(k)
FDA Class 2 ·Orthopedic

IBD-SCAN

FDA 510(k)
FDA Class 1 ·Immunology

IBD-CHEK

FDA 510(k)
FDA Class 1 ·Immunology

Influenza B IgG Control

FDA UDI
Bion Enterprises, Ltd.·B110IBG21200·

Peng’s Multifunctional Operative Dissector(PMOD)

FDA UDI
Zhejiang Shuyou Surgical Instrument Co.,Ltd.·06924274910046·

Peng’s Multifunctional Operative Dissector(PMOD)

FDA UDI
Zhejiang Shuyou Surgical Instrument Co.,Ltd.·06924274958086·