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Available for immediate download.
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FDA 510(k) K153057, FitRite™ Total Hip Arthroplasty System, by Excera Orthopedics, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K153064, Blue Sky Bio Zygomatic Implant System, by Blue Sky Bio, LLC
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K153203, Navigation Instruments, by Globus Medical, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K153229, Superbium, by Bios S.R.L.
Regular price $1,039.01 USDRegular priceUnit price / perSale price $1,039.01 USD -
FDA 510(k) K153249, Pulpdent Solo Flowable Composite with MCP, by Pulpdent Corporation
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K153283, VivoSight Dx Topical OCT System, by Michelson Diagnostics, Ltd.
Regular price $367.15 USDRegular priceUnit price / perSale price $367.15 USD -
FDA 510(k) K153302, coflex-IF, by Paradigm Spine, LLC
Regular price $654.79 USDRegular priceUnit price / perSale price $654.79 USD -
FDA 510(k) K153309, BD Vacutainer UltraTouch Push Button Blood Collection Set, by Becton, Dickinson and Company
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K153459, TACVAC, by Athena Gtx
Regular price $299.00 USDRegular priceUnit price / perSale price $299.00 USD -
FDA 510(k) K153473, Braemar Telemetry Patch System, by Braemar Manufacturing, LLC
Regular price $983.37 USDRegular priceUnit price / perSale price $983.37 USD -
FDA 510(k) K153479, NvisionVLE Imaging Console, Marking Probes (14/17/20mm) and Inflation System, by Ninepoint Medical, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K153548, VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM, by Visionsense, Ltd.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K153549, OSSIX VOLUMAX, by Datum Dental, Ltd.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K153618, Capillus202, by Capillus, LLC
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K153642, DAILIES AquaComfort Plus, Toric and Multifocal, by Alcon Laboratories, Inc.
Regular price $485.39 USDRegular priceUnit price / perSale price $485.39 USD -
FDA 510(k) K153645, VITA ENAMIC Implant Solutions (IS), by Vita Zahnfabrik H.Rauter GmbH Co.
Regular price $680.13 USDRegular priceUnit price / perSale price $680.13 USD -
FDA 510(k) K153745, Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider, by Surgical Instrument Service and Savings Inc.(Dba Medline Ren
Regular price $1,036.07 USDRegular priceUnit price / perSale price $1,036.07 USD -
FDA 510(k) K153753, TelioCAD Multi, by Ivoclar Vivadent, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K153754, MicroMatrix, by Acell, Inc.
Regular price $279.44 USDRegular priceUnit price / perSale price $279.44 USD -
FDA 510(k) K153756, Microlyte Ag, by Imbed Biosciences, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K153778, Nester Embolization Coils, Tornado Embolization Coils, by Cook Incorporated
Regular price $191.03 USDRegular priceUnit price / perSale price $191.03 USD -
FDA 510(k) K160016, Steth IO, by Stratoscientific, Inc.
Regular price $64.94 USDRegular priceUnit price / perSale price $64.94 USD -
FDA 510(k) K160044, Image1 SPIES System, by Karl Storz Endoscopy America, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160062, AUTION ELEVEN Semi-Automated Urinalysis System, by Arkray, Inc.
Regular price $3,035.09 USDRegular priceUnit price / perSale price $3,035.09 USD -
FDA 510(k) K160064, MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System, by Infobionic, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160068, FilmArray Respiratory Panel (RP) for use with FilmArray Torch, by Biofire Diagnostics, LLC
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160127, iCodeConnect, by 3B Medical, Inc.
Regular price $733.44 USDRegular priceUnit price / perSale price $733.44 USD -
FDA 510(k) K160147, CT TrueView, by Philips Medical Systems Nederland B.V.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160172, Laparoscope Lens Shield Device, by Medeon Biodesign, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160237, Cefaly, by Cefaly Technology
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160252, OmniPod Insulin Management System, by Insulet Corporation
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160254, GORE DrySeal Flex Introducer Sheath, by W. L. Gore & Associates, Inc.
Regular price $299.00 USDRegular priceUnit price / perSale price $299.00 USD -
FDA 510(k) K160327, ALADDIN HW3.0, by Visia Imaging S.R.L.
Regular price $1,317.21 USDRegular priceUnit price / perSale price $1,317.21 USD -
FDA 510(k) K160339, Cardinal Health Isolation Gown, by Cardinal Health200, LLC
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160360, Barrx FLEX RFA Energy Generator, by Covidien, LLC
Regular price $700.99 USDRegular priceUnit price / perSale price $700.99 USD -
FDA 510(k) K160364, VersaWrap Tendon Protector, by Alafair Biosciences, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD