11 results
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17ms
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Sources: EU EUDAMED, US FDA
MONOCLONAL ANTIBODY T4 RADIO-KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780519430·CODMAN® HAKIM® Precision Fixed Pressure Valve R...
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780534686·Precision Fixed Pressure Valve Right Angle Valv...
CODMAN HAKIM SIPHONGUARD
FDA UDI
Cerenovus, Inc.·10886704041658·CODMAN HAKIM Precision Fixed Pressure Valve Rig...
RMGI LOW VISCOSITY
FDA 510(k)
FDA Class 2
·Dental
CryoX Vitrification Freeze Kit / Thaw Kit
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·February 19, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 7, 2012
PD1200 DEFIBRILLATOR/PACEMAKER
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 27, 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
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