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OriGen Biomedical, Inc.

12 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: recall (Z-1068-2024)OriGen Biomedical, Inc.2024-02-09
Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethy recall (Z-1409-2021)OriGen Biomedical, Inc.2021-04-10
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F recall (Z-1227-2019)OriGen Biomedical, Inc.2019-06-04
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F recall (Z-1228-2019)OriGen Biomedical, Inc.2019-06-04
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F recall (Z-1229-2019)OriGen Biomedical, Inc.2019-06-04
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F recall (Z-1230-2019)OriGen Biomedical, Inc.2019-06-04
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F recall (Z-1231-2019)OriGen Biomedical, Inc.2019-06-04
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F recall (Z-1232-2019)OriGen Biomedical, Inc.2019-06-04
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0 recall (Z-0269-2019)OriGen Biomedical, Inc.2018-11-07
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire rein recall (Z-0021-2018)OriGen Biomedical, Inc.2017-10-20
OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE M recall (Z-1456-2015)OriGen Biomedical, Inc.2015-04-23
Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. recall (Z-0055-06)Origen Biomedical, Inc2005-10-15

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