16 results
·
28ms
·
Sources: EU EUDAMED, US FDA
FAHL TRACHEOSTOMY TUBES (MULTIPLE)
FDA 510(k)
FDA Class 2
·Anesthesiology
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
FDA 510(k)
FDA Class 2
·Dental
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973295·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970690·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970676·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970645·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970621·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970638·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970683·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970652·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970669·
XCM BIOLOGIC TISSUE MATRIX
FDA Adverse Event
Malfunction
·KENSEY NASH CORP.·Product code FTM·May 13, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code OYC·September 26, 2014
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·June 14, 2011
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