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Available for immediate download.
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FDA 510(k) K160403, SmartStart Air/Water and Suction Valves, by Endochoice, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160417, Rezum System, by Nxthera, Inc.
Regular price $611.11 USDRegular priceUnit price / perSale price $611.11 USD -
FDA 510(k) K160420, SpeqT, by Signostics Limited
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160429, BC-5390 Auto Hematology Analyzer, by Mindray Bio-Medical Electronics Co., Ltd.
Regular price $1,456.31 USDRegular priceUnit price / perSale price $1,456.31 USD -
FDA 510(k) K160433, V-PRO® 1 Plus and V-PRO® maX Low Temperature, by STERIS Corporation
Regular price $709.34 USDRegular priceUnit price / perSale price $709.34 USD -
FDA 510(k) K160434, ClearPoint System, by Mri Interventions, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160449, Penumbra System, Penumbra Pump MAX, by Penumbra, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160501, Noxilizer Surgical Ruler, by Noxilizer, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160526, Masimo O3 Regional Oximeter System, by Masimo Corporation
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160629, InPen, by Companion Medical, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160707, CustomizedBone Service, by Fin-Ceramica Faenza S.P.A.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160729, Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5, by Roche Diagnostics
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160743, Philips Ingenuity CT, by Philips Medical Systems (Cleveland), Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160749, CRIT-LINE III Blood Chamber II, by Fresenius Medical Care Renal Therapies Group, LLC
Regular price $567.46 USDRegular priceUnit price / perSale price $567.46 USD -
FDA 510(k) K160752, HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length, by Ethicon Endo-Suregery, LLC
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160783, Procellera, by Vomaris Innovations, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160811, CRW STEREOTACTIC SYSTEM, by Integra LifeSciences Corporation
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160845, Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device, by Boston Scientific Corporation
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160887, Cook Intraosseous Infusion Needles, by Cook Incorporated
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160907, DePuy Actis DuoFix Hip Prosthesis, by Depuy(Ireland)
Regular price $478.43 USDRegular priceUnit price / perSale price $478.43 USD -
FDA 510(k) K160925, VPS Rhythm Device with TipTracker Technology, by Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K160959, Xsert Lumbar Expandable Interbody System, by X-Spine Systems, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K161090, Cranial PSI, by Ossdsign AB
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K161112, KARL STORZ Flexible Video-Neuro-Endoscope System, by KARL STORZ Endoscopy-America, Inc.
Regular price $415.84 USDRegular priceUnit price / perSale price $415.84 USD -
FDA 510(k) K161126, ASAHI Corsair Pro, by Asahi Intecc Co., Ltd.
Regular price $210.53 USDRegular priceUnit price / perSale price $210.53 USD -
FDA 510(k) K161201, ClearRead CT, by Riverain Technologies, LLC
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K161210, Rialto SI Fusion System with IPC Powerease and StealthStation Instruments, by Medtronic Sofamor Danek
Regular price $116.94 USDRegular priceUnit price / perSale price $116.94 USD -
FDA 510(k) K161266, Athena Breast Pump, by Exploramed Nc7, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K161298, ShenDa Sinuscope, by Shenyang Shenda Endoscope Co., Ltd.
Regular price $1,029.27 USDRegular priceUnit price / perSale price $1,029.27 USD -
FDA 510(k) K161307, NICO Myriad, by Nico Corporation
Regular price $1,593.02 USDRegular priceUnit price / perSale price $1,593.02 USD -
FDA 510(k) K161315, Vein Clamps, Artery Clamps, by Aros Surgical Instruments Corporation
Regular price $262.53 USDRegular priceUnit price / perSale price $262.53 USD -
FDA 510(k) K161328, Cantab Mobile, by Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K161330, Pour Acrylic, by Dentsply Sirona
Regular price $439.49 USDRegular priceUnit price / perSale price $439.49 USD -
FDA 510(k) K161354, MELODY, Remote Control System for Ultrasound Probe, by Adecho Tech
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K161355, invendoscopy E200 System, by Invendo Medical GmbH
Regular price $302.83 USDRegular priceUnit price / perSale price $302.83 USD -
FDA 510(k) K161382, LVivo Software Application, by Diacardio, Ltd.
Regular price $392.19 USDRegular priceUnit price / perSale price $392.19 USD