22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
FDA 510(k)
FDA Class 2
·Neurology
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 8, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 29, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 29, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 29, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 29, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 29, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 8, 2022
BELMONT UNIT, MODEL 2000 SERIES
FDA 510(k)
FDA Class 1
·Dental
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DIO·March 27, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 13, 2025
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DIO·May 23, 2017
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DIO·May 8, 2017
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code DIO·October 4, 2019
5.0 CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 5, 2013
QUANTIUM TTC BILIARY BALLOON DILATOR
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNQ·March 10, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQL·June 12, 2008
DISPOSABLE DUAL CON LEAD SET
FDA Adverse Event
Malfunction
·COVIDIEN·Product code IKD·November 25, 2020
Contour¿ next GEN Blood Glucose Monitoring System
FDA Enforcement
Class II
·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023