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UNKNOWN UNCEMENTED PRESS-FIT RHEAD STEM

FDA Adverse Event
Injury ·STRYKER GMBH·Product code JBD·October 16, 2019

12.5MM ENTRY REAMER

FDA Adverse Event
Malfunction ·SMITH & NEPHEW, INC.·Product code JBD·December 2, 2019

SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems

FDA Recall
Open, Classified ·Helena Laboratories, Corp.·Product code JBD·February 27, 2018

RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.

FDA Recall
Terminated ·PerkinElmer LAS Inc·Product code JBD·June 29, 2004

HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France

FDA Recall
Terminated ·Sebia, Inc.·Product code JBD·August 29, 2006

System, Analysis, Electrophoretic Hemoglobin

FDA classification
FDA Class 2 ·System, Analysis, Electrophoretic Hemoglobin

(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·February 19, 2025

JBC CORP

FDA registration
JBC CORP·5 products·🇺🇸 United States

JBC AND COMPANY

FDA registration
JBC AND COMPANY·1 product·🇺🇸 United States

JBC TECHNOLOGIES, INC.

FDA registration
JBC TECHNOLOGIES, INC.·1 product·🇺🇸 United States

JBC TECHNOLOGIES, INC.

FDA registration
JBC TECHNOLOGIES, INC.·1 product·🇺🇸 United States

(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338

FDA Recall
Open, Classified ·CareFusion 303, Inc.·Product code BRY·January 8, 2025

CBD DENTAL LAB, INC

FDA registration
CBD DENTAL LAB, INC·11 products·🇨🇳 China

I3SYSTEM-ABD

FDA 510(k)
FDA Class 2 ·Radiology

IBD Medical Trading Pty Ltd.

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

Glucology

FDA UDI
IBD MEDICAL·09352945004423·Adhesive Sensor Patch

Glucology

FDA UDI
IBD MEDICAL·09352945004270·Adhesive Sensor Patch

Glucology

FDA UDI
IBD MEDICAL·09352945004355·Adhesive Sensor Patch

Glucology

FDA UDI
IBD MEDICAL·09352945004393·Adhesive Sensor Patch

Glucology

FDA UDI
IBD MEDICAL·09352945004331·Adhesive Sensor Patch