26 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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K133801
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2024
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
FDA 510(k)
FDA Class 2
·General Hospital
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 26, 2021
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 27, 2020
Portex
FDA UDI
ICU MEDICAL, INC.·15019517085051·
ADVIA Centaur® Cuvettes
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414221588·Laboratory analyser cuvette, IVD
HYPOTHERMX INTRAVENOUS FLUID WARMER
FDA 510(k)
FDA Class 2
·General Hospital
KYPHX HV-R, MODEL C01A
FDA 510(k)
FDA Class 2
·Orthopedic
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Injury
·KYPHON, INC.·Product code NDN·June 23, 2006
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Injury
·KYPHON, INC.·Product code NDN·June 20, 2006
TOTAL ASR ACET IMP SIZE 56
FDA Adverse Event
Death
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 1, 2014
AEQUALIS
FDA Adverse Event
Injury
·TORNIER SAS·Product code KWS·May 23, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·May 12, 2011
ADVIA CENTAUR INTACT PTH (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 24, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·January 7, 2015
ADVIA CENTAUR INTACT PTH (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·December 19, 2014
ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·November 1, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 29, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·June 15, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·August 30, 2016