8 results
·
29ms
·
Sources: EU EUDAMED, US FDA
AUDIOMETERS (VARIOUS MODELS)
FDA 510(k)
FDA Class 2
·Neurology
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788221770·Tranquil-L Implant Remover
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
FENESTRATED BIPOLAR FORCEPSINSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 20, 2014
CONVEEN OPTIMA 25
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code EXJ·April 26, 2012
ENDOPATH** XCEL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 1, 2010
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024