27 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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