5,158 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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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