26 results · 21ms · Sources: EU EUDAMED, US FDA

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HOSPIRA CATH LAB CONVENIENCE KITS

FDA 510(k)
FDA Class 2 ·Cardiovascular

Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SUPERSTITCH VASCULAR SUTURING DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026

PENUMBRA SYSTEM REPERFUSION CATHETER 054

FDA Adverse Event
Injury ·PENUMBRA, INC.·Product code NRY·April 11, 2013

ASR ACETABULAR IMP SZ 56

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 7, 2011

PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 27, 2008

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021

BD PHOENIX SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·May 6, 2021

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 22, 2021

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 8, 2024