510(k) Clearances in 2020 — Page 19

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 19 of 59)
510(k) clearancesDetails
K193340 — GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring SystemMicrotech Medical, Inc. Sep 11, 2020
K201959 — DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate SystemDePuy Synthes Sep 11, 2020
K201859 — Porcine Mineral Collagen Composite MoldableCollagen Matrix, Inc. Sep 11, 2020
K201909 — RxSight Contact LensRxsight, Inc. Sep 10, 2020
K200845 — Navigation Module of the Momentum SystemUlrich Medical USA Sep 10, 2020
K201450 — Straight T Clear Dental AlignerStraight T, Inc. Sep 10, 2020
K202008 — Disposable Vinyl GloveBest Care Trading Co., Ltd. Sep 10, 2020
K193212 — DSM Biomedical Dental Bone Graft PlusDsm Biomedical Sep 10, 2020
K202156 — DIAMOND-5A/6A/8ADRGEM Corporation Sep 10, 2020
K201330 — Tigereye CTO-Crossing CatheterAvinger, Inc. Sep 10, 2020
K202242 — HS FiberRiverpoint Medical, LLC Sep 10, 2020
K201944 — DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)Synthes (USA) Products, LLC Sep 10, 2020
K201731 — Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd. Sep 10, 2020
K201407 — CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. Sep 10, 2020
K201145 — X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc. Sep 10, 2020
K201738 — SubNovii Advanced Plasma TechnologyCartessa Aesthetics Sep 10, 2020
K200135 — RGK Daily Range WheelchairsRgk Wheelchairs, Ltd. Sep 10, 2020
K193462 — ClotTriever Thrombectomy SystemInari Medical Sep 9, 2020
K200851 — Vivid T8, Vivid T9GE Medical Systems Ultrasound And Primary Care Diagnostics Sep 9, 2020
K201551 — KetoSens BT Blood B-Ketone Monitoring SystemI-Sens, Inc. Sep 9, 2020
K200708 — Vivid iqGe Medical Systems Ultrasound And Sep 9, 2020
K192653 — PerseusOrthokey Italia S.R.L. Sep 9, 2020
K192730 — CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UVBiosystems S.A. Sep 9, 2020
K202153 — Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC Sep 9, 2020
K193409 — Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products Sep 9, 2020
K202256 — 3Shape Implant Studio3Shape Medical A/S Sep 9, 2020
K201948 — AcroDTI VisualizerAcroviz, Inc. Sep 9, 2020
K201578 — DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC Sep 9, 2020
K201252 — Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH Sep 9, 2020
K193664 — SubQKath Catheter and Needle SetHk Surgical Sep 9, 2020
K201539 — Keeogo Dermoskeleton SystemB-Temia, Inc. Sep 9, 2020
K200027 — Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample AdapterJiangsu Caina Medical Co.,Ltd Sep 9, 2020
K201090 — Structur CADVoco GmbH Sep 9, 2020
K201829 — SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)Medline Industries, Inc. Sep 9, 2020
K192822 — Benesta HysteroscopeCaldera Medical, Inc. Sep 9, 2020
K192423 — MINT Product FamilyHans Biomed Corporation Sep 9, 2020
K202252 — ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N),Asahi Intecc Co., Ltd. Sep 8, 2020
K201470 — Disposable Medical Face MaskJkh USA, LLC Sep 8, 2020
K201194 — Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. Sep 8, 2020
K202014 — Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fitSiemens Medical Solutions USA, Inc. Sep 8, 2020
K202354 — Surgical Mask-Model Number CW01Hunan Heng Chang Pharmaceutical Co., Ltd. Sep 8, 2020
K202328 — CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. Sep 8, 2020
K201841 — EyeBOXOculogica, Inc. Sep 6, 2020
K202335 — Ambra ProViewerDicom Grid Inc Dba Ambra Health Sep 4, 2020
K192524 — Lumipulse G CA15-3Fujirebio Diagnostics,Inc. Sep 4, 2020
K193341 — iCTmotor (WL-1)Dentium Co., Ltd. Sep 4, 2020
K201721 — TruLift Expandable Spacer SystemLife Spine, Inc. Sep 4, 2020
K201225 — Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A. Sep 4, 2020
K192538 — BD Syringe NRFit Lok and BD Syringe NRFit SlipBecton, Dickinson And Company Sep 4, 2020
K190561 — NICU V'02Cosmed Nordic Aps Sep 4, 2020
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