GKT

AMICUS Separator System

Advisory panel: Hematology
Total cleared: 10

Adverse events under product code GKT

product code GKT

Death: 167
Injury: 301
Malfunction: 2,086
Total: 2,554

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code GKT

K200530 — AMICUS Separator System Fresenius Kabi AG · 2020-09-11
K162462 — AMICUS Separator System, AMICUS Separator System; Refurbished Fresenius Kabi USA,Llc · 2016-11-23
K822521 — AUTOMATED BLOOD CELL SEPARATOR Cryosan, Inc. · 1982-09-30
K820396 — AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR Pheragen Technology Corp. · 1982-04-27
K801233 — CELLTRIFUGE II Travenol Laboratories, S.A. · 1980-10-31
K791106 — STERILE, DISPOSABLE CENTRIFUGE BOWL Travenol Laboratories, S.A. · 1979-08-10
K790105 — TERUMO IMUGARD Terumo America, Inc. · 1979-05-24
K781803 — FILTER, EYRPUR DISPOSABLE LEUKOCITE Metrix Teknika, Inc. · 1979-01-17
K771258 — BLOOD CELL SEPARATOR 2997 Intl. Business Machines · 1977-09-06
K760856 — BLOOD CELL PROCESSOR MODEL 2 IBM 2991 Intl. Business Machines · 1977-01-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.