16 results · 22ms · Sources: EU EUDAMED, US FDA

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Arthrex FastThread Interference Screw

FDA 510(k)
FDA Class 2 ·Orthopedic

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197537100·Titanium Eufrat Pasque Needleholder diamon...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197537117·Titanium Eufrat Pasque Needleholder diamon...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197537124·Titanium Eufrat Pasque Needleholder diamon...

FEMVUE CORNUAL BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

COVIDIEN

FDA Adverse Event
Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

COVIDIEN

FDA Adverse Event
Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·January 28, 2026

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·April 26, 2022

ENDOVIVE? STANDARD PEG KIT

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·October 17, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 20, 2013

SOFTHEAT

FDA Adverse Event
Other ·KAZ, INC.·Product code IRT·July 21, 2011

HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·February 25, 2019

HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

FDA Adverse Event
Death ·HEARTWARE, INC.·Product code DSQ·February 25, 2019

Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020