27 results · 32ms · Sources: EU EUDAMED, US FDA

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DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE

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

DUO-VENT CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 29, 2022

AUTOPULSE RESUSCITATION SYSTEM MODEL 100

FDA Adverse Event
Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·June 3, 2013

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·October 31, 2022

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 1, 2022

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FPA·October 3, 2016

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 26, 2025

ST. JOSEPH HSP BALTIMORE MD1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DWF·October 1, 2010

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 16, 2020

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 16, 2020

AUTOPULSE LI-ION BATTERY

FDA Adverse Event
Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 17, 2014

SPACEMAKER EXTRA VIEW BALLOON - OVAL

FDA Adverse Event
Malfunction ·USSC PUERTO RICO·Product code GCJ·May 25, 2011

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 14, 2020

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·December 23, 2020

CHILDRENS MERCY KS CITY MO1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010

SMART, PERFUSION PACKS, CONNECTORS, TUBING

FDA Adverse Event
Malfunction ·LIVANOVA USA·Product code DWE·August 1, 2023