13 results
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17ms
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Sources: EU EUDAMED, US FDA
KM-KAL L6
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780518686·CODMAN® HAKIM® Precision Micro
Lymphotype HLA-AB 72 AN
FDA UDI
Bio-Rad Medical Diagnostics GmbH·07611969952731·for 6 detections of human HLA-AB antigens in th...
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780534228·Precision Fixed Pressure Valve Micro Valve with...
CODMAN HAKIM RICKHAM
FDA UDI
Cerenovus, Inc.·10886704041122·CODMAN HAKIM Precision Fixed Pressure Valve Mic...
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506061059·MEDIASTINOSCOPY ASPIRATION NEEDLE 23G, 22CM ...
SURGERY REHEARSAL PLATFORM
FDA 510(k)
FDA Class 2
·Radiology
LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 5, 2014
SCREW
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·November 7, 2012
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·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
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018