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Organon Teknika Corp.

United StatesFDA applicant, unverified

Devices
136
FDA recalls
1

Catalogue136

Newest first, rows 51-100 of 136

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  • Mb/Bact Blood Culture Bottle Ref K983772

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Pregnospia Ii Ref K881435

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Washer 500 Microelisa System Ref K884695

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Fluid Warmer Ref K842302

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bact/Alert Sv Ref K994343

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ciprofloxacin 5 Mcg Susceptibility Disk Ref K873707

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Auraflex Prolactin 200 Test Pack, Calibrator Pack, Dilvent 1 Ref K944698

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Bact/Alert (Tm) Ref K903505

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Mda D-Dimer Ref K000492

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pipette 12 Channel Ref K831644

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Packets For The Prep Of Dialysates & Ref K842154

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bact/Alert Pf Ref K992401

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Vironostika(Tm) Anti-Cmv Igm Microelisa System Ref K890610

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tof-Watch Ref K972698

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ampicillin/Sulbactam 10/10 Mcg Susceptibility Disk Ref K874256

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Asn Monitor Single Needle Monitor Ref K843531

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cefixime 5 Mcg Susceptibility Disk Ref K900344

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bact/Alert 120 Ref K934593

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Bact/Alert Blood Collection Adapter Cap And Insert Ref K933939

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Auraflex Tg-Ab And Tpo-Ab Ref K951320

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Aura Flex FT4 200 Test Pack, FT4 Calibrator Pack Ref K944697

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Coag-A-Mate Xc/Xc Plus Version D.00 Software Ref K885076

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bact/Alert Fan Culture Bottles Ref K973325

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • D-3260 Sorbent Cartridge Ref K812869

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tof-Watch Sx Ref K992598

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bsm 2000 Dialysis Machine - Modified Ref K850569

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Redy 2000 Ref K882428

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cefotetan 30 Mcg Antimicrobial Susceptibility Disk Ref K860895

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Asa Blood Tubing Lines Ref K854271

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Four Liter Bag For Use W/Redy 2000/Dialert Systems Ref K874607

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Sorb Ii Ref K813574

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Auratek Fdp Ref K943787

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Microplate Processor 3000 Ref K945135

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Bact/Alert Sn Ref K993421

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Auraflex(R) Estradiol Ref K946199

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Nephross Presto Ref K832666

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hcg-Nostick Ref K880328

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sorb System Urs Ref K792137

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Coag-A-Mate - RA4 Ref K900895

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Aztreonam 30 Mcg Susceptibility Disk Ref K870870

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Rubenostika(Tm) Igm Microelisa System Ref K882999

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Platelin(R) Excel L Ref K881999

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bact/Alert Csr Ref K003104

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Mda Heparin Anti-X Assay Ref K965076

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gen Diagnostics' Imipenem 10 Mcg Susceptibity Disk Ref K860031

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tof-Watch S Ref K992596

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Stripreader Microelisa System Ref K831643

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Multi-Channel Discrete Analyzer (Mda-180) Ref K924453

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Fast Formalert Ref K853555

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bact/Alert Fan Aerobic Culture Bottle Ref K935711

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 51-100 of 136

Showing 51-100 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.