510(k) Clearances in 2020 — Page 9

2,923 510(k) clearances total

Browse FDA 510(k) clearances granted in 2020. RegDataLab tracks 2,923 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2020 (page 9 of 59)
510(k) clearancesDetails
K202344 — TiUltra Implants and Xeal AbutmentsNobel Biocare AB Nov 16, 2020
K200706 — Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc. Nov 16, 2020
K200461 — Freeprint dentureDetax GmbH & Co. KG Nov 16, 2020
K201918 — EVOS Large Fragment Plating SystemSmith & Nephew, Inc. Nov 16, 2020
K202758 — Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd. Nov 16, 2020
K201060 — Cordiana Dx16Cordiana Medical Informatics AG Nov 16, 2020
K202370 — Ion Endoluminal SystemIntuitive Surgical, Inc. Nov 16, 2020
K202490 — Avid CT2Vision Quest Industries Inc./Dba VQ Orthocare Nov 16, 2020
K193193 — Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG Nov 16, 2020
K202762 — Circular Fixation with Balanced Cable TransportSmith & Nephew, Inc. Nov 16, 2020
K203149 — M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. Nov 16, 2020
K202343 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc. Nov 16, 2020
K200401 — ApogeeIncoba Ltd D/B/A Dynaris Nov 14, 2020
K202132 — VenueGE Medical Systems Ultrasound And Primary Care Diagnostics Nov 13, 2020
K202373 — APEX 3D Total Ankle Replacement SystemParagon 28, Inc. Nov 13, 2020
K201937 — Ceramir Restore QuikCapDoxa Dental AB Nov 13, 2020
K202178 — VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd. Nov 13, 2020
K200081 — NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. Nov 13, 2020
K192612 — Kerecis Gingiva GraftKerecis Limited Nov 13, 2020
K203011 — Monster Screw SystemParagon 28, Inc. Nov 13, 2020
K203040 — TSolution One Total Knee ApplicationTHINK Surgical, Inc. Nov 13, 2020
K202317 — Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806Everyway Medical Instruments Co.,Ltd Nov 13, 2020
K202620 — FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP Nov 13, 2020
K202355 — Stryker Omega PEEK Knotless Anchor SystemStryker Nov 13, 2020
DEN190029 — Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences Nov 13, 2020
K202966 — SIGNA ArchitectGe Healthcare (Ge Medical Systems, LLC) Nov 13, 2020
K201881 — CoroFlow Cardiovascular SystemCoroventis Research AB Nov 13, 2020
K200820 — SpeediCath Compact SetColoplast Nov 13, 2020
K201666 — SINGLE USE MANOMETERFlexicare Medical Limited. Nov 13, 2020
K200239 — Astroglide Organix GelBiofilm, Inc. Nov 13, 2020
K193411 — O2asis Personal Oxygen HumidifierPerma Pure, LLC Nov 12, 2020
K203173 — ExacTrac DynamicBrainlab AG Nov 12, 2020
K202571 — da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. Nov 12, 2020
K191433 — AGILON® XO Shoulder Replacement SystemImplantcast GmbH Nov 12, 2020
K201523 — Sharps containerZhejiang Gongdong Medical Technology Co., Ltd. Nov 12, 2020
K201568 — Calvary Spine Pedicle Screw SystemCalvary Spine, LLC Nov 12, 2020
K200335 — Sterisheet Sterilization WrapAndersen Sterilizers, Inc. Nov 12, 2020
K193385 — TP Orthodontics Clear Aligner SystemTp Orthodontics, Inc. Nov 12, 2020
K200336 — Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc. Nov 12, 2020
K193289 — FastStroke, CT Perfusion 4DGE Medical Systems SCS Nov 12, 2020
K203085 — NOVA Patient Warming SystemEncompass Group, LLC Nov 12, 2020
K192978 — EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc. Nov 12, 2020
K203082 — Insight Infrared Video GogglesVestibular First Nov 12, 2020
K201985 — KardiaAIAliveCor, Inc. Nov 12, 2020
K192980 — EOGas 4 Endo-SteriTestAndersen Sterilizers, Inc. Nov 12, 2020
K200334 — AN1036 DosimeterAndersen Sterilizers, Inc. Nov 12, 2020
K202074 — Apache Ultrasound System (Model C62)Compal Electronics, Inc. Nov 12, 2020
K203043 — Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. Nov 11, 2020
K203106 — Nio Fusion 12MP (MDNC-12130)Barco N.V. Nov 10, 2020
K183044 — JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd. Nov 10, 2020
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