Terumo BCT, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
1
Inspections
12
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0075-2018Class IIHARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph DeliverOctober 20, 2017
Z-0103-2018Class IIHARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, ROctober 20, 2017
Z-0104-2018Class IIHARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EOOctober 20, 2017
Z-0674-2017Class IIAdiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.November 3, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC CoSeptember 11, 2015