18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES (USA) DHS HELIX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERISTA IMAGING ISOCAM II GAMMA CAMERA
FDA 510(k)
FDA Class 1
·Radiology
Günther Tulip® Vena Cava Filter Retrieval Set
FDA 510(k)
FDA Class 2
·Cardiovascular
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·February 27, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
UNICEL® DXC 600 SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·February 8, 2011
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·March 17, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Injury
·COOK INC·Product code MMX·September 29, 2021
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·June 3, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·August 15, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·January 30, 2023
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Injury
·COOK INC·Product code MMX·February 6, 2023
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·July 27, 2021
AXIUM PRIME BRPL 3D
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·November 16, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·November 4, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·March 28, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Injury
·COOK INC·Product code MMX·August 18, 2022
Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma
FDA Recall
Terminated
·Abbott Laboratories Inc.·Product code CIX·March 10, 2010