20 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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XHIBIT CENTRAL STATION, MODEL 96102
FDA 510(k)
FDA Class 2
·Cardiovascular
Z Liquid HT A4-S 100ml
FDA UDI
ARGEN CORPORATION, THE·D818122146·Dental porcelain/ceramic restoration kit
BAHADIR STERILIZATION TRAYS
FDA 510(k)
FDA Class 2
·General Hospital
SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 4, 2023
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 29, 2023
SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·March 8, 2013
SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·December 12, 2012
SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·December 20, 2012
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK INC·Product code MIH·May 17, 2013
REPLY SR
FDA Adverse Event
Malfunction
·SORIN BIOMEDICA CRM S.R.L.·Product code DXY·June 13, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·August 14, 2008
SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·March 14, 2013
SUPRA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·December 20, 2012
SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·December 28, 2012
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
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
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020