12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THYROXINE ANALYSIS PRODUCTS/RADIO-FREE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780519423·CODMAN® HAKIM® Precision Fixed Pressure Valve R...
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780534679·Precision Fixed Pressure Valve Right Angle Valv...
CODMAN HAKIM SIPHONGUARD
FDA UDI
Cerenovus, Inc.·10886704041641·CODMAN HAKIM Precision Fixed Pressure Valve Rig...
MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
FDA 510(k)
FDA Class 2
·General Hospital
DK-PTCA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
AUTOPLEX SYSTEM W/ VERTAPLEX W/O NEEDLES
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-PUERTO RICO·Product code LOD·May 21, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 7, 2012
1600 SEMI AUTOMATIC DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 27, 2010
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 31, 2022
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018