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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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