8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
TOM CAT F.L., TOM CAT S.L.
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
artegral
FDA UDI
Merz Dental GmbH·D7091972245·posteriors; shade D3 light; size M; lower jaw
HAPTOGLOBIN NEPHELOMETRIC ASSAY
FDA 510(k)
FDA Class 2
·Immunology
EMULATE ADVANCED
FDA 510(k)
FDA Class 2
·Dental
ASR ACETABULAR IMPLANT 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·January 21, 2011
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
FDA Recall
Terminated
·B Braun Medical, Inc.·Product code FRN·November 14, 2012