19 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Ultrasonic Endo Activation Device (Model:Actor I pro)
FDA 510(k)
FDA Class 2
·Dental
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 4, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 4, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 4, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 4, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 4, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 4, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 4, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 4, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 4, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 4, 2022
Navident
FDA 510(k)
FDA Class 2
·Dental
ARCHITECT IVANCOMYCIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ARCHITECT IVANCOMYCIN
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LEH·May 20, 2026
LCS MENIS BEARING STD/10MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·October 27, 2008
MITEK VAPR III GENERATOR
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code GEI·August 17, 2011
HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·July 9, 2013
AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·March 7, 2018
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019