-
ANDA 211287: Approval Letter, Routing Sheet, CRL
Regular price $170.95 USDRegular priceUnit price per -
FDA 510(k) K000080, ASNIS III CANNULATED SCREW SYSTEM, by Howmedica Osteonics Corp.
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K000281, WALLSTENT ENTERNAL PROSTHESIS, by Boston Scientific Corp
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K000365, ACCU-CHEK ADVANTAGE METER, by Roche Diagnostics Corp.
Regular price $89.00 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) K000609, CARDTEL, MODEL NT-100, by Cardiac Telecommunications
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K000655, PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE, by Ahava Stein
Regular price $419.04 USDRegular priceUnit price per -
FDA 510(k) K000669, MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY, by Medivision Endoscopy
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K000795, RIGID GAS PERMEABLE CONTACT LENS, by Polymer Technology
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K000881, PERFADEX SOLUTION FOR ORGAN PRESERVATION, by Vitrolife Sweden AB
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K001086, FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900, by Diagnostic Systems Laboratories, Inc.
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K001122, PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH, by ETHICON, Inc.
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K001149, Augustine Medical Bair Hugger Model 750 Temperature Management System, by Augustine Medical, Inc.
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K001217, INSIDE VIEW, by Monadnock Optics, Inc.
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K001275, RETCAM II, by Massie Research Laboratories, Inc.
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K001337, DANIELS SHARPSMART REUSABLE SHARPS CONTAINER, by The Daniels Corp.
Regular price $210.54 USDRegular priceUnit price per -
FDA 510(k) K001338, MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER, by Boston Scientific Corp
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K001401, AMT THERAPEUTIC TABLE, MODEL 748AMT, by Amt Mfg., Inc.
Regular price $302.83 USDRegular priceUnit price per -
FDA 510(k) K001520, ALPHA OMEGA DUAL COOLER-HEATER, by Alpha Omega, Inc.
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K001781, CURRY MULTIMODAL NEUROIMAGING SOFTWARE, by Neurosoft, Inc.
Regular price $149.00 USDRegular priceUnit price per -
FDA 510(k) K001852, PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE, by Itamar Medical (C.M.) 1997 , Ltd.
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K001960, RIGID GAS PERMEABLE CONTACT LENS, by Polymer Technology
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K001989, COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES, by Zimmer, Inc.
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K002028, BRAVO PH MONITORING SYSTEM, by Endonetics, Inc.
Regular price $685.26 USDRegular priceUnit price per -
FDA 510(k) K002095, SNAP MODEL 6, by Snap Laboratories, LLC
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K002138, PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380, by Maersk Medical A/S
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K002255, LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC), by Wolfe Tory Medical, Inc.
Regular price $89.00 USDRegular priceUnit price per -
FDA 510(k) K002321, PAIN CARE 2000L, by Breg, Inc.
Regular price $89.00 USDRegular priceUnit price per
