510(k) Clearances in 2020 — Page 13

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 13 of 59)
510(k) clearancesDetails
K202044 — Powerpress Recovery UnitHanuri Distribution, Inc. Oct 21, 2020
K201155 — PleurX Peritoneal Catheter SystemCare Fusion Oct 21, 2020
K201415 — Vial2Bag Advanced 20mm Admixture DeviceWest Pharmaceutical Services Az, Inc. Oct 21, 2020
K201427 — Trivergent Spinal Fixation SystemBenvenue Medical, Inc. Oct 21, 2020
K202799 — EVA15Palliare , Ltd. Oct 21, 2020
K192771 — C4 Fiducial MarkerC4 Imaging, LLC Oct 21, 2020
K202472 — ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. Oct 21, 2020
K202030 — OASIS MRI SystemHitachi Healthcare Americas Oct 21, 2020
K202760 — Iridex 810 LaserIridex Corporation Oct 21, 2020
K193552 — InnovaMatrixTriad Life Sciences, Inc. Oct 21, 2020
K201724 — Pentacam AXL WaveOculus Optikgerate GmbH Oct 21, 2020
K201670 — YSIO X.preeSiemens Medical Solutions USA, Inc. Oct 21, 2020
K201884 — ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cmMicroline Surgical, Inc. Oct 21, 2020
K200507 — PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc Oct 21, 2020
K201268 — Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)Plexus Optix, Inc. Oct 21, 2020
K201610 — IonicRF GeneratorABBOTT MEDICAL Oct 21, 2020
K202393 — SpineJack Expansion KitStryker Corporation Oct 20, 2020
K202756 — Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)CooperVision, Inc. Oct 20, 2020
K201139 — WEGO-PDO Barbed SutureFoosin Medical Supplies Inc., Ltd. Oct 20, 2020
K181477 — MS Lide Implant SystemsHangzhou Minsheng Lide Medical Science & Technology Co., Ltd. Oct 20, 2020
K193000 — Hexanium® ACIFSpinevision, S.A.S. Oct 20, 2020
K200794 — AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. Oct 20, 2020
K202771 — CD Horizon Spinal SystemMedtronic Oct 19, 2020
K200821 — anti-bacterial bandagePlanet (Suzhou) Medical Products Co., Ltd. Oct 19, 2020
K201771 — Single Use Rotatable and Repositionable HemoclipAnrei Medical (Hangzhou) Co., Ltd. Oct 19, 2020
K201572 — TAPESTRY Biointegrative ImplantEmbody, Inc. Oct 19, 2020
K202374 — 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+Shenzhen Beacon Display Technology Co., Ltd. Oct 19, 2020
K202100 — Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)Neocis, Inc. Oct 19, 2020
K200084 — Zavation IBF SystemZavation Medical Products, LLC Oct 19, 2020
K200237 — Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd. Oct 19, 2020
K201535 — Cerament Bone Void FillerBonesupport AB Oct 16, 2020
K201803 — OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOSSIO , Ltd. Oct 16, 2020
K202193 — PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament ReconstructionS.B.M. Sas (Science & Bio Materials) Oct 16, 2020
K202016 — Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics Oct 16, 2020
K200045 — MUTARS Cemented Femoral StemsImplantcast GmbH Oct 16, 2020
K201396 — Finetest Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co. , Ltd. Oct 16, 2020
K202010 — Disposable Vinyl GloveBetter Health Medical Products Co., Ltd. Oct 16, 2020
K202733 — Quantum Ventilation ModuleSpectrum Medical , Ltd. Oct 16, 2020
K201710 — A View LCSCoreline Soft Co., Ltd. Oct 16, 2020
K202737 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound SystemCanon Medical Systems Corporation Oct 16, 2020
K200595 — CellaVision DC-1, CellaVision DC-1 PPACellaVision AB Oct 16, 2020
K201816 — ARTHROTAPAccuro Technologies, Inc. Oct 16, 2020
K201129 — Medline Smoke Evacuation PencilMedline Industires, Inc. Oct 16, 2020
K193474 — Selectra 3D Outer Guiding CathetersBiotronik, Inc. Oct 16, 2020
K200408 — VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer MediumShenzhen Vitavitro Biotech Co., Ltd. Oct 16, 2020
K200906 — MINICONE ImplantMedentika GmbH Oct 16, 2020
K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. Oct 15, 2020
K200764 — STATSTIXCentrix Incorporated Oct 15, 2020
K201587 — icotec Anterior Cervical Plate SystemIcotec AG Oct 15, 2020
K202349 — Cartesion Prime, PCD-1000A, V10.7Canon Medical Systems Corporation Oct 15, 2020
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