Collection: Industry
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Approval Routing Summary for ANDA # 213719 (Zydus)
Regular price $168.94 USDRegular priceUnit price / per -
FDA PMA P130022/S038
Regular price $927.73 USDRegular priceUnit price / per -
FDA P960031 — Periogard Periodontal Tissue Monitor
Regular price $1,137.77 USDRegular priceUnit price / per -
FDA NDA 019084 – Nizoral (Ketoconazole) Cream 2% Labeling and Package Insert
Regular price $104.95 USDRegular priceUnit price / per -
FDA BLA 125057, Supplement S-400, Humira, Approved on October 17, 2016
Regular price $184.95 USDRegular priceUnit price / per -
FDA Food Contact Notification (FCN) 1933 – Isononanoic Acid Esters with Dipentaerythritol
Regular price $250.00 USDRegular priceUnit price / per -
FDA 510(k) K162393, The ViewRay (MRIdian) Linac System, by Viewray, Incorporated
Regular price $177.37 USDRegular priceUnit price / per -
FDA 510(k) K180513, CustomizedBone Service, by Fin-Ceramica Faenza S.P.A.
Regular price $857.04 USDRegular priceUnit price / per -
FDA 510(k) K201867, Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System, by Baxter Healthcare Corporation
Regular price $177.37 USDRegular priceUnit price / per -
FDA 510(k) K071545, Z-800 VOLUMETRIC INFUSION PUMP, by Zyno Medical, LLC
Regular price $3,473.65 USDRegular priceUnit price / per -
FDA 510(k) K100705, ZYNO Z-800 INFUSION SYSTEM MODEL Z-800, by Zyno Medical, LLC
Regular price $1,614.72 USDRegular priceUnit price / per -
FDA 510(k) K120685, ZYNO MEDICAL ADMINISTRATION SET, by Zyno Medical, LLC
Regular price $2,571.31 USDRegular priceUnit price / per -
FDA 510(k) K130690, Z-800 INFUSION SYSTEM, by Zyno Medical, LLC
Regular price $2,502.60 USDRegular priceUnit price / per -
FDA 510(k) K202839, Overlapped Compression Therapy, by Jkh Health Co., Ltd.
Regular price $477.30 USDRegular priceUnit price / per -
FDA 510(k) K220075, Spartan Center Wire, by Spartan Micro, Inc.
Regular price $772.05 USDRegular priceUnit price / per -
FDA 510(k) K000471, FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT, by Future Diagnostics B.V.
Regular price $175.00 USDRegular priceUnit price / per -
FDA 510(k) K032716, PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE), by Portex , Ltd.
Regular price $341.30 USDRegular priceUnit price / per -
FDA 510(k) K032958, PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000, by United Medical Systems, Inc.
Regular price $1,106.59 USDRegular priceUnit price / per -
FDA 510(k) K131817, EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, by Osmunda Medical Device Consulting Co., Ltd.
Regular price $1,162.65 USDRegular priceUnit price / per -
FDA 510(k) K143094, QuantaFlo, by Semler Scientific, Inc.
Regular price $1,495.37 USDRegular priceUnit price / per -
FDA 510(k) K152055, Ceramax Skin Barrier Cream, by Oculus Innovative Sciences
Regular price $175.00 USDRegular priceUnit price / per -
FDA 510(k) K192579, X-Guide Surgical Navigation System, by X-Nav Technologies, LLC
Regular price $1,800.98 USDRegular priceUnit price / per -
FDA 510(k) K200662, X-Guide® Surgical Navigation System, by X-Nav Technologies, LLC
Regular price $800.99 USDRegular priceUnit price / per -
FDA 510(k) K210365, Second Opinion, by Pearl, Inc.
Regular price $3,500.00 USDRegular priceUnit price / per -
FDA 510(k) K210971, EnteraLoc Flow, by Vonco Products
Regular price $867.89 USDRegular priceUnit price / per -
FDA 510(k) K771228, LIFECARE EMPTY CONTAINER, by Abbott Laboratories
Regular price $175.00 USDRegular priceUnit price / per -
FDA 510(k) K791774, LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN, by Abbott Laboratories
Regular price $175.00 USDRegular priceUnit price / per -
FDA 510(k) K844077, NUTRIMIX EMPTY CONTAINER, by Abbott Laboratories
Regular price $175.00 USDRegular priceUnit price / per -
FDA 510(k) K875076, FLORIDA PROBE, by Florida Probe Corp.
Regular price $199.34 USDRegular priceUnit price / per -
FDA 510(k) K903058, BACT-HME (TM), by Pharma Systems, Inc.
Regular price $177.37 USDRegular priceUnit price / per -
FDA 510(k) K920501, SILCLAMPS DEGANIA SILICONE, by Puritas Health Care, Inc.
Regular price $314.26 USDRegular priceUnit price / per -
FDA 510(k) K991972, INFANT FLOW SYSTEM, by Sensor Medics Corp.
Regular price $273.70 USDRegular priceUnit price / per -
FDA 510(k) K100341, SPERMCHECK FERTILITY, by Princeton BioMeditech Corp.
Regular price $341.30 USDRegular priceUnit price / per -
FDA 510(k), K223609, RevCore™ Thrombectomy Catheter.
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K223299, Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220195, iFuse Bedrock Granite™ Implant System
Regular price $1,667.74 USDRegular priceUnit price / per