18 results · 21ms · Sources: EU EUDAMED, 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