510(k) Clearances in 2017 — Page 30

3,200 510(k) clearances total

Browse FDA 510(k) clearances granted in 2017. RegDataLab tracks 3,200 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2017 (page 30 of 64)
510(k) clearancesDetails
K171003 — 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader3M Company Jul 21, 2017
K161527 — Teco Creatinine Enzymatic Reagent KitTeco Diagnostics, Inc. Jul 21, 2017
K171597 — Vantage Elan 1.5T, V4.0Toshibamedical Systems Corporation Jul 21, 2017
K171753 — BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16Leica Biosystems Newcastle, Limited Jul 21, 2017
K163232 — Vitrea ViewVital Images, Inc. Jul 21, 2017
K152257 — Fujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc. Jul 21, 2017
K171855 — External Moisturizing GelCombe Incorporated Jul 21, 2017
K171441 — ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension KitLuminex Corporation Jul 21, 2017
K170223 — ProgreatAshitaka Factory Of Terumo Corporation Jul 21, 2017
K170532 — True Form Reshapable Guide WireMerit Medical Systems, Inc. Jul 21, 2017
K170832 — Ultimax-i, DREX-UI80 V1.60Toshibamedical Systems Corporation Jul 21, 2017
K163589 — SIGN IM NailSign Fracture Care International Jul 20, 2017
K162219 — CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. Jul 20, 2017
K171616 — Xingyu Powder Free Nitrile Patient Examination Gloves, Blue colorShandong Xingyu Gloves Co., Ltd. Jul 20, 2017
K170219 — Microlife Digital Infrared Ear ThermometerMicrolife Intellectual Property GmbH Jul 20, 2017
K171439 — EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate SystemMedos International SARL Jul 20, 2017
K171701 — GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp. Jul 20, 2017
K170326 — dynaMX Intramedullary ImplantArthrex, Inc. Jul 20, 2017
K163025 — DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. Jul 20, 2017
K171425 — CONCORDE LIFTMedos International SARL Jul 20, 2017
K170675 — Graftgun Universal Graft Delivery SystemSurGenTec, LLC Jul 19, 2017
K170978 — Embrace Neonatal MRI SystemAspect Imaging, Ltd. Jul 19, 2017
K170379 — Disposable Standard ClampStandard Bariatrics Jul 19, 2017
K171093 — STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREESanrea Healthcare Products Pvt, Ltd. Jul 19, 2017
K171812 — Nio Color 2MP (MDNC-2123)Barco N.V. Jul 19, 2017
K163687 — OLINDA EXMHermes Medical Solutions AB Jul 19, 2017
K163159 — Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. Jul 19, 2017
K163388 — XPress BCD Breast Compression DeviceXpress Bcd, LLC Jul 19, 2017
K170775 — Mini Stick ENVI Non-Vascular Introducer KitAngioDynamics, Inc. Jul 19, 2017
K171957 — MaxZero Extension Sets with Needless ConnectorCarefusion 303, Inc. Jul 19, 2017
K170852 — POD Packing CoilPenumbra, Inc. Jul 19, 2017
K171838 — TiLock2 Spinal SystemGenesys Spine Jul 19, 2017
K171290 — Vela RX PTA Balloon Dilatation CatheterCuratia Medical Jul 19, 2017
K170182 — CARDIOVIT FT-1Schiller AG Jul 19, 2017
DEN170022 — QuantXQuantitative Insights, Inc. Jul 19, 2017
K170100 — CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. Jul 18, 2017
K162510 — Non-Sterile, Powder-Free, Nitrile Examination Gloves, BlueUg Global Resources Sdn. Bhd. Jul 18, 2017
K162856 — Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)Bonart Co., Ltd. Jul 18, 2017
K170729 — Examion X-AQSExamion GmbH Jul 18, 2017
K171149 — Altrix Temperature Management WrapsStryker Medical Jul 18, 2017
K171544 — Arterys ViewerArterys, Inc. Jul 18, 2017
K171021 — JO Agapé Personal LubricantUnited Consortium Jul 18, 2017
K171807 — ES2 Neuromonitoring Accessory InstrumentsStryker Corporation Jul 18, 2017
K163064 — Demi UltraKerr Corporation Jul 18, 2017
K163714 — OSSIX BONEDatum Dental, Ltd. Jul 18, 2017
K171333 — 20G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.) Jul 18, 2017
K171824 — Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. Jul 18, 2017
K170786 — Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC Jul 18, 2017
K171844 — Inspire ICE aka Inspire ICE Clear BracketsOrmco Corporation Jul 18, 2017
K170613 — Genius Total Knee SystemSignature Orthopaedics Pty, Ltd. Jul 17, 2017
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