Organon Teknika Corp.
United StatesFDA applicant, unverified
- Devices
- 136
- FDA recalls
- 1
DeviceDevice · Authorizations Verified Status Regime Registry Class
Auraflex Hcg Ref K945331
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISimplastin Excel S Ref K882214
Active Regimes: 510(k) Registry: 510(k) ClassClass:IINephross I.Q. Allego Ref K882213
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMda Simplastin Ls Ref K952608
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDialyzer, Capillary, Hollow Fiber Ref K853591
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAuraflex B2-Microglobulin Ref K944846
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIHd-Secura Hemadialysis Machine Ref K854367
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMb/Bact Blood Culture Bottle Ref K982263
Active Regimes: 510(k) Registry: 510(k) ClassClass:INml Tsh Irma Ref K854087
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Mda Simplastin Htf Ref K974566
Active Regimes: 510(k) Registry: 510(k) ClassClass:IINephross Dialyzer Ref K802114
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIK1 Potassium Acetate Additive Ref K801385
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIFibrinostika Fbdp Microelisa System Ref K912876
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBact/Alert Mb Culture Bottle Ref K000378
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRubenostika Igg Microelisa System Ref K911393
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAuraflex Ck-Mb 200TEST Pack, Calibrator Pack Ref K951638
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBact/Alert Fan Culture Bottle Ref K944594
Active Regimes: 510(k) Registry: 510(k) ClassClass:IHemoperfusion Procedure W/Redy 2000 Ref K842513
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICoag-A-Mate(R) Xm Ref K881281
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBact/Alert Pedi-Bact Ref K920249
Active Regimes: 510(k) Registry: 510(k) ClassClass:INephross I.Q. Moderato Ref K882215
Active Regimes: 510(k) Registry: 510(k) ClassClass:IINorfloxacin 10 Mcg Susceptibility Disk Ref K864848
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIToxonostika Igm Microelisa System Ref K862196
Active Regimes: 510(k) Registry: 510(k) ClassClass:IINephross Allegro H.F. Ref K844748
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBact/Alert Fn Ref K992432
Active Regimes: 510(k) Registry: 510(k) ClassClass:INative Prothrombin Antigen Eia Ref K910617
Active Regimes: 510(k) Registry: 510(k) ClassClass:IReader Microelisa System Ref K831641
Active Regimes: 510(k) Registry: 510(k) ClassClass:IOrganon Teknida Chromostrae (Tm) Heparin Anti-Xa Ref K903841
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAuraflex Testosterone Calibrator Pack Ref K951685
Active Regimes: 510(k) Registry: 510(k) ClassClass:I9EPANOSTIKA(Tm) Anti-Hav Igm Ref P830017
Active Regimes: PMA Registry: PMA ClassClass:IIHepanostika(Tm) Anti-Hav Midroelisa System Ref P830018
Active Regimes: PMA Registry: PMA ClassClass:II- Active Regimes: PMA Registry: PMA ClassClass:II
Autobac Mic Test System Ref N50524
Active Regimes: PMA Registry: PMA ClassClass:IICuresis Plasma Separator Ref P830010
Active Regimes: PMA Registry: PMA ClassClass:—Amibacin Elution Disk For Autobac Ref N50485
Active Regimes: PMA Registry: PMA ClassClass:II
Rows 101-136 of 136
Showing 101-136 of 136
FDA recalls1
Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 11 Jan 2019 Z-0962-2019 Class II Terminated This notice has been initiated due to potential for compromised test card Top Seal Integrity which could: - yield false resistance for antibiotics on the AST panel - cause a false negative ESBL Test - result in a false positive urea (URE) reaction on ID cards Distribution: Worldwide distribution.