510(k) Clearances in 2020 — Page 32

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 32 of 59)
510(k) clearancesDetails
K192337 — ZerovenoDimedi Co., Ltd. Jun 22, 2020
K201430 — InFrame™ Cannulated Fixation SystemExsomed Corp. Jun 20, 2020
K191923 — EverLift Submucosal Lifting AgentGi Supply Jun 20, 2020
K200671 — Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested forAnsell Healthcare Products, LLC Jun 19, 2020
K192963 — Kogent Torus Ultrasonic AspiratorKatalyst Surgical, LLC Jun 19, 2020
K200438 — MPS 3 Myocardial Protection SystemQuest Medical, Inc. Jun 19, 2020
K191913 — TruAbutment DSTruabutment, Inc. Jun 19, 2020
K201370 — Multiflex Tinnitus TechnologyStarkey Laboratories, Inc. Jun 19, 2020
K200574 — EksoNREkso Bionics, Inc. Jun 19, 2020
K200471 — Infrared Thermometer Model Number RN-60A,RN-60BNingbo Ranor Medical Science & Technology Co., Ltd. Jun 19, 2020
K190637 — Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd. Jun 19, 2020
K192910 — STATClave G4 Chamber AutoclaveScican , Ltd. Jun 19, 2020
K193106 — SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. Jun 19, 2020
K192024 — Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd. Jun 19, 2020
K201340 — AQUILA 320 D / AQUILA 320 SVmi Tecnologias Ltda Jun 19, 2020
K192954 — Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and FentanylComfort Rubber Gloves Industries Sdn. Bhd. Jun 19, 2020
K193298 — BriefCaseAidoc Medical , Ltd. Jun 19, 2020
K201339 — The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc. Jun 19, 2020
K200297 — Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH Jun 18, 2020
K201327 — NavLock TrackersMedtronic Navigation Jun 18, 2020
K200892 — Harvey(R) Surgical AssistantOrthalign, Inc. Jun 18, 2020
K192604 — Servo-air 4.0 Ventilator SystemMaquet Critica Care AB Jun 18, 2020
K193234 — NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. Jun 18, 2020
K201347 — DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc. Jun 18, 2020
K192274 — BV Dental Implant SystemBio Concept Co., Ltd. Jun 18, 2020
K193620 — OptoMonitor 3Opsens, Inc. Jun 18, 2020
K200727 — TENS and Muscle StimulatorShenzhen Astec Technology Co., Ltd. Jun 18, 2020
K201311 — PF4 IgG assayImmucor Gti Diagnostics, Inc. Jun 18, 2020
K200283 — Medussa-PL CageMedyssey USA, Inc. Jun 18, 2020
K200424 — Giotto Class (Models - 3000X-YY and 4000X-YY)Ims Giotto S.P.A. Jun 18, 2020
K200481 — Andorate Biopsy Valve, Andorate Biopsy IrrigatorGa Health Company Limited Jun 18, 2020
K193513 — SIGNAFUSE Bioactive Bone GraftBioventus Jun 18, 2020
K201337 — InPen SystemCompanion Medical, Inc. Jun 18, 2020
K201220 — Aerus Medical Guardian,model F170AAerus Medical, LLC Jun 17, 2020
K200875 — ArtiSential Laparoscopic Instruments - ElectrodesLivsmed, Inc. Jun 17, 2020
K193399 — Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. Jun 17, 2020
K192747 — Yxoss CBR®Reoss GmbH Jun 17, 2020
K193290 — AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc. Jun 17, 2020
K201322 — Entuit Nasal Jejunal Feeding TubeWilson-Cook Medical, Inc. Jun 17, 2020
K193253 — Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503Shenzhen Changkun Technology Co., Ltd. Jun 17, 2020
K201029 — Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc. Jun 17, 2020
K192478 — LT Antibacterial Alginate with Silver DressingZhejiang Longterm Medical Technology Co., Ltd. Jun 17, 2020
K200389 — INOmax DSIR PlusMallinckrodt Manufacturing, LLC Jun 17, 2020
K201319 — Medline UNITE Jones Fracture Screw SystemMedline Industires, Inc. Jun 17, 2020
K200921 — qERQure.Ai Technologies Jun 17, 2020
K192542 — Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, ElectordeModern Medical Equipment Manufacturing, Ltd. Jun 16, 2020
K201023 — iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. Jun 16, 2020
K200467 — Control-IQ TechnologyTandem Diabetes Care, Inc. Jun 16, 2020
K193288 — Koya RippleKoya, Inc. Jun 16, 2020
K190408 — Spinal Fixation SystemShangdong Kangsheng Medical Devices Co., Ltd. Jun 16, 2020
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