11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 12, 2018
EDS COMBO-RINSE
FDA 510(k)
FDA Unclassified
·Unknown
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
FDA 510(k)
FDA Class 2
·Microbiology
CERTAIN¿ BELLATEK¿ ENCODE¿ HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H)
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·June 15, 2023
BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code JKA·April 7, 2024
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008
T-LINK DATA MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DWA·August 16, 2011
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 16, 2013
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025