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1002FDAA2405: FDA Approval BLA 125062/674

USD 56.0

Adverse Events: Elevidys (Delandistrogene Moxeparvovec)

USD 77.94

Adverse Events: Syfovre

USD 413.06

ANDA -- 219115 -- Bioequivalence Review (Dexlansoprazole Del

USD 376.89

ANDA -- 219115 -- Chemistry, Manufacturing, and Controls (CM

USD 146.84

ANDA 211287: Approval Letter, Routing Sheet, CRL

USD 170.95

Approval Routing Summary for ANDA # 213719 (Zydus)

USD 168.94

CAP - 4C0326 - FDA Phytolon Color Petition Submission Docume

USD 1550.0

CAP - 4C0326 - Phytolon Color Petition Submission Document -

USD 1550.0
FDA 510(k) K000080, ASNIS III CANNULATED SCREW SYSTEM, by Howmedica Osteonics Corp.

FDA 510(k) K000080, ASNIS III CANNULATED SCREW SYSTEM, by Ho

USD 89.0
FDA 510(k) K000281, WALLSTENT ENTERNAL PROSTHESIS, by Boston Scientific Corp

FDA 510(k) K000281, WALLSTENT ENTERNAL PROSTHESIS, by Boston

USD 89.0
FDA 510(k) K000365, ACCU-CHEK ADVANTAGE METER, by Roche Diagnostics Corp.

FDA 510(k) K000365, ACCU-CHEK ADVANTAGE METER, by Roche Diag

USD 89.0
FDA 510(k) K000471, FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT, by Future Diagnostics B.V.

FDA 510(k) K000471, FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERAT

USD 175.0
FDA 510(k) K000609, CARDTEL, MODEL NT-100, by Cardiac Telecommunications

FDA 510(k) K000609, CARDTEL, MODEL NT-100, by Cardiac Teleco

USD 89.0
FDA 510(k) K000655, PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE, by Ahava Stein

FDA 510(k) K000655, PPCID- PNEUMATIC PERIPHERAL CIRCULATION

USD 419.04
FDA 510(k) K000669, MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY, by Medivision Endoscopy

FDA 510(k) K000669, MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY

USD 89.0
FDA 510(k) K000795, RIGID GAS PERMEABLE CONTACT LENS, by Polymer Technology

FDA 510(k) K000795, RIGID GAS PERMEABLE CONTACT LENS, by Pol

USD 89.0
FDA 510(k) K000881, PERFADEX SOLUTION FOR ORGAN PRESERVATION, by Vitrolife Sweden AB

FDA 510(k) K000881, PERFADEX SOLUTION FOR ORGAN PRESERVATION

USD 89.0
FDA 510(k) K001086, FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900, by Diagnostic Systems Laboratories, Inc.

FDA 510(k) K001086, FREE TESTOSTERONE ENZYME IMMUNOASSAY, MO

USD 89.0
FDA 510(k) K001122, PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH, by ETHICON, Inc.

FDA 510(k) K001122, PROLENE SOFT (POLYPROPYLENE), NONABSORBA

USD 89.0
FDA 510(k) K001149, Augustine Medical Bair Hugger Model 750 Temperature Management System, by Augustine Medical, Inc.

FDA 510(k) K001149, Augustine Medical Bair Hugger Model 750

USD 89.0
FDA 510(k) K001217, INSIDE VIEW, by Monadnock Optics, Inc.

FDA 510(k) K001217, INSIDE VIEW, by Monadnock Optics, Inc.

USD 89.0
FDA 510(k) K001275, RETCAM II, by Massie Research Laboratories, Inc.

FDA 510(k) K001275, RETCAM II, by Massie Research Laboratori

USD 89.0
FDA 510(k) K001337, DANIELS SHARPSMART REUSABLE SHARPS CONTAINER, by The Daniels Corp.

FDA 510(k) K001337, DANIELS SHARPSMART REUSABLE SHARPS CONTA

USD 210.54