510(k) Clearances in 2020 — Page 23

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 23 of 59)
510(k) clearancesDetails
K201352 — 3D Auto LAAPhilips Health Care Aug 17, 2020
K193240 — Universal Cylinder Applicator FamilyVarian Medical Systems, Inc. Aug 17, 2020
K200648 — EKOS PE Endovascular Device with Control System 4.0 (CS4.0)Ekos Corporation Aug 17, 2020
K192597 — Cytrans GranulesGC America, Inc. Aug 17, 2020
K193492 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc. Aug 17, 2020
K192845 — Sperm Freeze, Sperm FridgeKitazato Corporation Aug 17, 2020
K201399 — HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera HeadKarl Storz-Endoscopy-America, Inc. Aug 17, 2020
K193408 — Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona Aug 16, 2020
K200848 — Stimulator, Stimulator Kit, External Transmitter, External Transmitter KitMicron Medical Corporation Aug 14, 2020
K202068 — The AIO Solution 3.0Orfit Industries NV Aug 14, 2020
K201010 — Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeNobio , Ltd. Aug 14, 2020
K200064 — OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC Aug 14, 2020
K202276 — BracePaste Band and Build LCAmerican Orthodontics Aug 14, 2020
K200775 — LOOP LED Curing Light SystemGarrison Dental Solutions, LLC Aug 14, 2020
K191708 — Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd. Aug 14, 2020
K192682 — Orthocem, Ortho BiteDentscare Ltda Aug 14, 2020
K201518 — Route 92 Medical 088 Access SystemRoute 92 Medical Aug 14, 2020
K201632 — TOMTEC-ARENATomtec Imaging Systems GmbH Aug 14, 2020
K201232 — Limbus ContourLimbus Ai, Inc. Aug 13, 2020
K201916 — Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenatorSorin Group Italia S.R.L. Aug 13, 2020
K200133 — hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamSafecare Biotech (Hangzhou) Co., Ltd. Aug 13, 2020
K200822 — BraidBraid.Health Aug 13, 2020
K192947 — AncestryDNA Saliva Collection KitAncestry Genomics, Inc. Aug 13, 2020
K181645 — StimaWELL 120MTRSPierenkemper GmbH Aug 13, 2020
K201961 — IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc. Aug 13, 2020
K192611 — CuffixBiovo Technologies , Ltd. Aug 13, 2020
K193429 — Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. Aug 13, 2020
K201444 — Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. Aug 13, 2020
K192944 — AncestryDNA Factor V Leiden Genetic Health Risk TestAncestry Genomics, Inc. Aug 13, 2020
K193046 — Straumann® Retentive System – Novaloc TiN AbutmentsInstitut Straumann AG Aug 13, 2020
K201960 — SpaceFlex Knee - 80mm SizeG21, S.R.L. Aug 13, 2020
K200895 — Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc. Aug 13, 2020
K201174 — TruDi CuretteAcclarent, Inc. Aug 12, 2020
K200763 — Osteo-site Vertebral BalloonIzi Medical Aug 12, 2020
K201871 — Surgical MaskC & S Paper Yunfu Co., Ltd. Aug 12, 2020
K193312 — UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc. Aug 12, 2020
K201637 — Aurora Evacuator +CoagRebound Therapeutics Aug 12, 2020
K201099 — BD PhaSeal Optima Closed System Drug Transfer DeviceBecton, Dickinson And Company Aug 12, 2020
K192620 — SNA-001 Silver Photoparticle Topical GelSienna Biopharmaceuticals, Inc. Aug 12, 2020
K200838 — Tyece OTC TENS ModelTyece Limited Aug 12, 2020
K201248 — Syringe Holder accessoryVapocoolshot, Inc. Aug 12, 2020
K200534 — VisualEyesInteracoustics A/S Aug 12, 2020
K201054 — SOMNOscreen plusSomnomedics GmbH Aug 12, 2020
K200529 — OrionInteracoustics A/S Aug 12, 2020
K201722 — Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine Research, Inc. Aug 11, 2020
K201286 — 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouchNurse Assist, LLC Aug 11, 2020
K201953 — OMNI PLUS Surgical SystemSight Sciences, Inc. Aug 11, 2020
K201588 — CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round IceVarian Medical Systems, Inc. Aug 11, 2020
K200981 — Mega Plus MIS Spine SystemBk Meditech, Co., Ltd. Aug 11, 2020
K200740 — HD Video Rhino LaryngoscopeKARL STORZ Endoscopy-America, Inc. Aug 11, 2020
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