Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list OriGen Biomedical with 19 device recalls and 4 510(k) clearances. The most recent is a device recall dated Dec 19, 2023: Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 19, 2023 | Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cClass II · Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the s | Device recalls |
| Jan 28, 2021 | Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or laClass III · It was identified that tissue culture bags were incorrectly labeled as free of phthalates. | Device recalls |
| Jun 24, 2019 | 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx OnlyClass II · The firm has become aware that they have distributed product that was expired. | Device recalls |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28FClass I · Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear | Device recalls |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19FClass I · Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear | Device recalls |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13FClass I · Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear | Device recalls |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23FClass I · Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear | Device recalls |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32FClass I · Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear | Device recalls |
| Jul 26, 2012 | ORIGEN REINFORCED DUAL LUMEN CATHETERK113869 · DWF | 510(k) clearances |
| Aug 6, 2002 | CRYOBAG, MODEL CBK021702 · LPZ | 510(k) clearances |
| Jun 8, 2001 | ORIGEN DUAL LUMEN CATHETERK003288 · DQO | 510(k) clearances |
| Apr 20, 2001 | ORIGEN BLADDER HOLDERK003145 · DWC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
