14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aesculap Caiman 12 Seal and Cut Technology System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLEXCERA BASE
FDA Adverse Event
Malfunction
·ENVISIONTEC GMBH·Product code EBI·November 10, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·October 8, 2020
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
COLGATE DESENSITIZING DENTAL CREAM
FDA 510(k)
FDA Class 2
·Dental
TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·October 17, 2008
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code INM·July 2, 2013
CE-2000 OPTHALMIC CRYO SYSTEM DIG
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HQA·September 30, 2019
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·November 20, 2013
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025