26 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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