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FDA PMA medical devices

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1,751 devices

  • Atellica IM free PSA II (fPSAII) Ref P250026

    Siemens Healthcare Diagnostics,United States
    Active Regimes: PMA Registry: PMA Class:III
  • Signatera™ CDx Ref P260004

    Natera, Inc.,United States
    Active Regimes: PMA Registry: PMA Class:III
  • LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus Ref P250039

    Diasorin Inc.,United States
    Active Regimes: PMA Registry: PMA Class:III
  • Dacron Surgical Sutures Ref P880094

    Alcon Laboratories, Inc.,United States
    Active Regimes: PMA Registry: PMA Class:II
  • Breast Companion Software System Ref P100007

    Almen Laboratories, Inc.,FDA registration: United States
    Withdrawn Regimes: PMA, withdrawn Registry: PMA Class:II
  • Cds Ii (Sodium Chondroitin Sulfate) Ref P820079

    Alcon Laboratories, Inc.,United States
    Withdrawn Regimes: PMA, withdrawn Registry: PMA Class:III
  • Guardian(R) Atp Ii Implantable Cardioverter/Difib. Ref P940024

    Telectronics Pacing Systems, Inc.,United States(FDA applicant)
    Active Regimes: PMA Registry: PMA Class:III
  • Modified J&C Loop Post. Chamber Intraocular Lens Ref P900037

    Medical Development Research, Inc.,FDA registration: United States
    Active Regimes: PMA Registry: PMA Class:III
  • 9EPANOSTIKA(Tm) Anti-Hav Igm Ref P830017

    Organon Teknika Corp.,United States(FDA applicant)
    Active Regimes: PMA Registry: PMA Class:II
  • Spinal Epidural Electrode For P.E.N.S. Model E-355 Ref P810033

    Avery Biomedical Devices, Inc.,FDA registration: United States
    Withdrawn Regimes: PMA, withdrawn Registry: PMA Class:III
  • Corab-M Ref P830014

    Abbott Laboratories,United States
    Active Regimes: PMA Registry: PMA Class:II
  • Percutaneus Transluminal Coronary Angioplasty Cath Ref P940009

    Scimed Life Systems, Inc.,United States(FDA applicant)
    Active Regimes: PMA Registry: PMA Class:II
  • ClearVisc Ophthalmic Viscosurgical Device (OVD) Ref P200025

    Bausch Health,FDA registration: United States
    Active Regimes: PMA Registry: PMA Class:III
  • Sandimmune(R) Radioimmunoassay Kit Ref P850086

    Sandoz Pharmaceuticals Corp.,FDA registration: United States
    Active Regimes: PMA Registry: PMA Class:II
  • Therascreen Kras Rgq Pcr Kit Ref P110030

    QIAGEN Manchester, Ltd.,FDA registration: United Kingdom
    Withdrawn Regimes: PMA, withdrawn Registry: PMA Class:III
  • Streptomycin Suefate Diagnostic Susceptibility Pow Ref N50036

    Pfizer Inc.,United States
    Active Regimes: PMA Registry: PMA Class:II
  • Yagmaster Nd:yag Op Laser Ref P850091

    Bausch & Lomb, Inc.,United States(FDA applicant)
    Withdrawn Regimes: PMA, withdrawn Registry: PMA Class:III
  • Softics (Deltafilcon A) Lens Ref P790015

    Advanced Soft Optics, Inc.,FDA registration: United States
    Active Regimes: PMA Registry: PMA Class:II
  • Womed Leaf Resorbable Adhesion Barrier Ref P240015

    Womed Sas,FDA registration: France
    Active Regimes: CE MDR PMA Registry: PMA Class:III
  • Therapeutic Apheresis System Ref P850092

    Millipore Corp.,United States(FDA applicant)
    Withdrawn Regimes: PMA, withdrawn Registry: PMA Class:—