40 results · 31ms · Sources: EU EUDAMED, US FDA

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PSS SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BIOMET EXTERNAL WRIST PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

ST AIA-PACK CA 19-9

FDA 510(k)
FDA Class 2 ·Immunology

UNKNOWN

FDA Adverse Event
Malfunction ·COOK, INC.·Product code DTK·August 21, 2014

UNK

FDA Adverse Event
Injury ·COOK, INC.·Product code DTK·August 20, 2014

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code DTK·August 20, 2014

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 23, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 9, 2014

TENDRIL ST

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008

GUNTHER TULIP VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·April 3, 2026

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DTK·September 12, 2017

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·November 11, 2021

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·December 5, 2017

GUNTHER TULIP VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·November 4, 2025

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·June 4, 2019

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DTK·May 21, 2019

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DTK·March 3, 2017

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DTK·February 22, 2018

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DTK·September 22, 2017

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DTK·September 6, 2017