19 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Customized Abutment and Screw
FDA 510(k)
FDA Class 2
·Dental
MEDICOMPASS CONNECT
FDA 510(k)
FDA Class 2
·Cardiovascular
Instru-Safe Instrument Protection System
FDA 510(k)
FDA Class 2
·General Hospital
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·December 29, 2020
BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·December 3, 2020
BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 30, 2020
BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 12, 2020
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·December 31, 2020
BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·November 11, 2020
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 12, 2020
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·November 3, 2020
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·February 9, 2021
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·January 20, 2021
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
UNIFY CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 10, 2011
EZ BREATH ATOMIZER & 10 ASTHMANEFRIN VIALS (STARTER KIT)
FDA Adverse Event
Malfunction
·NEPHRON PHARMACEUTICALS CORP·Product code CCQ·July 18, 2013
BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·November 25, 2020
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 20, 2020
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025