510(k) device

List of 510(k) Products approved in January 2020

Have a look into this section for continous update of 510(k) approved products of medical device as per the approval by FDA.

510(K) NUMBERPRODUCTCOMPANYAPPROVAL DATE
K181005ClenchGuardBoyd Research Inc.01-15-2020
K181089SureLead Cable SystemAuthentic Medical01-17-2020
K181546Dillard Nasal Balloon CatheterIntuit Medical Products LLC01-03-2020
K183074TENS and EMS Stimulator TENS StimulatorAstek Technology Ltd.01-11-2020
K183089Air NextNuvoAir AB01-02-2020
K183284INTRAcel RF Microneedle SystemJeisys Medical Inc.01-15-2020
K190028UNO 30Genadyne Biotechnologies01-15-2020
K190243Z5-BLZ-Systems AG01-03-2020
K190306AMD Ritmed AssureWear VersaGownAMD Medicom Inc.01-17-2020
K190316Icare ic200Icare Finland Oy01-14-2020
K190651ERBECRYO 2 Cryosurgical UnitErbe Elektromedizin GmbH01-07-2020
K190669EndoticsEra Endoscopy s.r.l.01-03-2020
K190871Bio-TackS Orthodontic Mini ImplantBio Cetec Co. Ltd.01-17-2020
K190878Trach- Vac Endotracheal Tube (SFTVPU)Salter Labs Inc.01-10-2020
K190942Disposable Powder Free Nitrile Examination Glove Pink/Black ColorEver Growth (Vietnam) Co. Ltd.01-07-2020
K190981NEX-D2 Posterior Fixation SystemNext OrthoSurgical01-15-2020
K191020G210 InviCell Plus with SignipHy pH monitoringCooperSurgical Inc.01-14-2020
K191052HyaloGYN Vaginal Moisturizing SuppositoriesFidia Farmaceutici S.p.A01-09-2020
K191056Conformity stem cementedUnited Orthopedic Corporation01-03-2020
K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic Inc01-02-2020
K191095Maxxi Snore SensorNeurovirtual USA INC.01-16-2020
K191123Multi-unit AbutmentsMedentika GmbH01-06-2020
K191125ADAS 3DGalgo Medical S.L01-15-2020
K191147OC-Auto SENSOR io iFOB TestEiken Chemical Co. Ltd.01-02-2020
K191195PiccGuardPiccGuard LLC01-03-2020
K191210Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions LLC01-09-2020
K191221Cybird LED Curing LightDXM Co. Ltd01-10-2020
K191266VitalScan ANSMedeia Inc.01-15-2020
K191275Allae InCath 035M PTA Balloon Dilatation CatheterNexStep Medical01-15-2020
K191446Ureteral Stent Systems Biliary Drainage CathetersBoston Scientific Corporation01-02-2020
K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine01-08-2020
K191501PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co. Ltd.01-03-2020
K191538Resectr Tissue Resection DeviceBoston Scientific Corporation01-16-2020
K191581Endoskeleton TL Interbody Fusion DeviceTitan Spine Inc01-08-2020
K191642TK Sterile Piston Syringe without NeedleAnhui Tiankang Medical Technology Co.Ltd.01-06-2020
K191678IP ConverterSony Electronics Inc.01-10-2020
K191692KardioScreeniMedrix Inc. (formerly Piitech Inc.)01-10-2020
K191717Route 92 Medical Sheath SystemRoute 92 Medical Inc.01-13-2020
K191739Sterile LeadConfirmAlpha Omega Engineering Ltd.01-02-2020
K191802Electric Breast PumpNingbo Huiyoo Baby Products Co. Ltd.01-16-2020
K191831MobiliT CupCorin USA Limited01-16-2020
K191870VV330 Continuous ECG Platform VivaLNK Adhesive PatchVivaLNK Inc.01-07-2020
K191907OptoWire IIIOpsens Inc.01-02-2020
K192004Eko Analysis SoftwareEko Devices Inc01-15-2020
K192009LED Curing LightEZGO Group Inc.01-09-2020
K192115SABLE Expandable SpacerGlobus Medical Inc.01-14-2020
K192182C015Micronica SRL01-17-2020
K192211SoundBite Console SoundBite Active Wire 18SoundBite Medical Solution Inc.01-17-2020
K192216Invacare AVIVA FX Power Wheelchair Model: IFX-20MPInvacare Corporation01-02-2020
K192251Livento Press Soprano 10 SopranoCendres+Metaux SA01-15-2020
K192302Mahurkar Acute Single Lumen CatheterCovidien llc01-17-2020
K192307Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden OrangeMed Inc.01-10-2020
K192315Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)Medline Industries Inc.01-10-2020
K192357INNOVOAtlantic Therapeutics Ltd.01-16-2020
K192363AltaporeBaxter Healthcare Corporation01-09-2020
K192409Midwest Rhino XE and Air Motor MDentsply Sirona01-13-2020
K192412SD500 Elite LubeFree High Speed HandpieceDentalEZ Inc.01-06-2020
K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences LLC01-17-2020
K192429Dental Pain EraserSynapse Dental01-14-2020
K192454Wattson Temporary Pacing GuidewireVascular Solutions01-15-2020
K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S01-02-2020
K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems01-17-2020
K192497EVOL ha – D Lateral Interbody Fusion SystemCutting Edge Spine LLC01-06-2020
K192544Erchonia EmeraldErchonia Corporation01-13-2020
K192547MAGLUMI  2000 Hcg/ß-hcgShenzhen New Industries Biomedical Engineering Co. Ltd01-17-2020
K192563Altera gas Sampling LinesMeditera Tibbi Malzeme San. ve Tic. A.S.01-17-2020
K192583PicoLazer Laser SystemRohrer Aesthetics LLC01-17-2020
K192599ASAHI PTCA Guide Wire ASAHI Gaia NextAsahi Intecc Co. Ltd.01-02-2020
K192606SAC2 – Electrode CreamSpes Medica S.r.l.01-17-2020
K192635Powder Free Nitrile Patient Examination Gloves Non-Sterile (Orange)WRP ASIA PACIFIC SDN BHD01-17-2020
K192687TrellOss-I MpFNexxt Spine LLC01-09-2020
K192696TriMed ASET Foot Plating SystemTriMed Inc.01-05-2020
K192715CRF Radiofrequency Ablation SystemCambridge Interventional LLC01-07-2020
K192750AcTiFlip Naked AcTiFlip Cinch AcTiFlip WHIP GFS Ultimate HipParcus Medical LLC01-16-2020
K192754Avenger Radial Head SystemIn2Bones USA LLC01-07-2020
K192761Asimov-MKS Imaging SystemOnLume Inc.01-17-2020
K192767Clear AlignerRoyal Dental Lab01-08-2020
K192774BioCardia 8F Morph DNA Deflectable Guide CatheterBioCardia01-07-2020
K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology Inc. (DBA RTI Surgical Inc.)01-14-2020
K192827Quadra-PMedacta International SA01-06-2020
K192869SherpaPak Lung Preservation System  SherpaPak Liver Transport SystemPragonix Technologies01-16-2020
K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG01-03-2020
K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co. Ltd01-06-2020
K192917ViewPoint 6GE Medical Systems Ultrasound and01-06-2020
K192920Oragene DxDNA Genotek Inc.01-14-2020
K192926RxSight Insertion DeviceRxSight Inc.01-17-2020
K192942ALLthread Titanium Suture AnchorBiomet Inc.01-16-2020
K192956Auto PositioningGE Hangwei Medical Systems Co. Ltd.01-16-2020
K192966FlowMetLaser Associated Sciences Inc.01-10-2020
K192974Tyber Medical Trauma ScrewTyber Medical LLC01-08-2020
K192975Tyber Medical Trauma ScrewsTyber Medical LLC01-09-2020
K192995OsteoRemedies Hip Spacer SystemOsteoRemedies LLC01-10-2020
K193007LiNA OperaScope with HDMI cable and on-board LCD – 6 units LiNA OperaScope Recording ModuleLiNA Medical ApS01-17-2020
K193011CD Horizon Fenestrated Screw SetMedtronic Sofamor Danek USA Inc.01-10-2020
K193024SensititreThermo Fisher Scientific01-08-2020
K193045Geko W-2Firstkind Limited01-18-2020
K193092TunneLoc Tibial Fixation DeviceBiomet Inc.01-02-2020
K193102MRIaudio PREM System with MRIviewMRIaudio Inc.01-06-2020
K193125R2P Destination Slender Guiding SheathTerumo Medical Corporation01-06-2020
K193137EASYGRIP FLO-41 Precision MIS Delivery SystemBaxter Healthcare Corportation01-08-2020
K193140Flex Body SPEEDERQuality Electrodynamics LLC01-03-2020
K193182Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.01-17-2020
K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution Inc. (MiiS)01-14-2020
K193225KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography KDR AU System Advanced U-Arm with Static Digital RadiographyKonica Minolta Healthcare Americas Inc01-15-2020
K193239MPowRx Snoring Solution (also known as Good Morning Snore Solution)MPowRx Health and Wellness Products 2012 Inc01-03-2020
K193359SureMAX Family of Cervical SpacersAdditive Implants Inc01-03-2020
K193360Acuity SDR Standard Acuity SDR Plus Acuity FDR StandardRadmedix LLC01-02-2020
K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex Inc.01-10-2020
K193375NeuroBlate SystemMonteris Medical01-03-2020
K193431AlignRT PlusVision RT Ltd01-03-2020
K193433AMIStem-CMedacta International SA01-09-2020
K193440ER-REBOA PLUS CatheterPrytime Medical Devices Inc01-09-2020
K193452MotoBAND CP Implant SystemCrossRoads Extemity Systems LLC01-10-2020
K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings LLC01-10-2020
K193478XTRAC Momentum Excimer Laser SystemStrata Skin Sciences Inc.01-14-2020
K193488GlideScope BFlex 3.8 Single-Use BronchoscopeVerathon Medical (Canada) ULC01-16-2020
K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics Inc.01-15-2020
K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis Ltd.01-16-2020
K193503Arthrex SwiveLock Suture AnchorArthrex Inc.01-15-2020
K193507Merit ONE Snare SystemMerit Medical Systems Inc.01-17-2020
K193509AcQGuide Flex with AcQCross QX AcQGuide Mini with AcQCross QXAcutus Medical Inc.01-17-2020
K193543CoLink Plating System Fracture and Correction System CoLink Mini Plating System CoLink View Plating System CoLink Afx Plating SystemIn2Bones USA LLC01-17-2020
K193547CustomizedBone ServiceFin-Ceramica Faenza Spa01-17-2020
K193548Mirage Hydrophilic Guidewire X-pedion Hydrophilic GuidewireMicro Therapeutics Inc. d/b/a ev3 Neurovascular01-18-2020
K193570Dental Pain EraserSynapse Dental01-17-2020
K193590CareSens S Fit BT Blood Glucose Monitoring Systemi-SENS Inc.01-17-2020
K193611Viveve 2.0 SystemViveve Medical Inc.01-16-2020
K193645nva nvp and nvtNvision Biomedical Technologies Inc.01-13-2020
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