39 results · 23ms · Sources: EU EUDAMED, US FDA

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VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Genius Total Knee System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021917·

MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM

FDA 510(k)
FDA Class 1 ·Microbiology

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

LCP WRIST FUSION STRAIGHT PLATE

FDA Adverse Event
Injury ·SYNTHES ELMIRA·Product code HRS·April 23, 2013

VICTORY XL DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·September 9, 2014

VIRTUOSO DR

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code LWS·April 28, 2011

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