510(k) Clearances in 2020 — Page 58

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 58 of 59)
510(k) clearancesDetails
K192115 — SABLE Expandable SpacerGlobus Medical, Inc. Jan 14, 2020
K190316 — Icare ic200Icare Finland OY Jan 14, 2020
K191020 — G210 InviCell Plus with SignipHy pH monitoringCooperSurgical, Inc. Jan 14, 2020
K191717 — Route 92 Medical Sheath SystemRoute 92 Medical, Inc. Jan 13, 2020
K192544 — Erchonia EmeraldErchonia Corporation Jan 13, 2020
K193645 — nva, nvp, and nvtNvision Biomedical Technologies, Inc. Jan 13, 2020
K192409 — Midwest Rhino XE and Air Motor MDentsply Sirona Jan 13, 2020
K183074 — TENS and EMS Stimulator, TENS StimulatorAstek Technology , Ltd. Jan 11, 2020
K192966 — FlowMetLaser Associated Sciences, Inc. Jan 10, 2020
K193465 — CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC Jan 10, 2020
K191678 — IP ConverterSony Electronics, Inc. Jan 10, 2020
K193011 — CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. Jan 10, 2020
K191221 — Cybird LED Curing LightDxm Co., Ltd. Jan 10, 2020
K192315 — Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)Medline Industries, Inc. Jan 10, 2020
K192307 — Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc. Jan 10, 2020
K190878 — Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuffSalter Labs, Inc. Jan 10, 2020
K191692 — KardioScreenImedrix Inc. (Formerly Piitech Inc.) Jan 10, 2020
K193372 — Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc. Jan 10, 2020
K193452 — MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC Jan 10, 2020
K192995 — OsteoRemedies Hip Spacer SystemOsteoremedies, LLC Jan 10, 2020
K193433 — AMIStem-CMedacta International S.A. Jan 9, 2020
K192363 — AltaporeBaxter Healthcare Corporation Jan 9, 2020
K192975 — Tyber Medical Trauma ScrewsTyber Medical, LLC Jan 9, 2020
K192009 — LED Curing LightEzgo Group, Inc. Jan 9, 2020
K191052 — HyaloGYN Vaginal Moisturizing SuppositoriesFidia Farmaceutici S.P.A. Jan 9, 2020
K193440 — ER-REBOA PLUS CatheterPrytime Medical Devices, Inc. Jan 9, 2020
K192687 — TrellOss™-L MPFNexxt Spine, LLC Jan 9, 2020
K191210 — Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC Jan 9, 2020
K192767 — Clear AlignerRoyal Dental Lab Jan 8, 2020
K192974 — Tyber Medical Trauma ScrewTyber Medical, LLC Jan 8, 2020
K193024 — Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mLThermo Fisher Scientific Jan 8, 2020
K191489 — Genesys Spine 3DP Cervical Interbody SystemGenesys Spine Jan 8, 2020
K191581 — Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion DeviceTitan Spine, Inc. Jan 8, 2020
K193137 — EASYGRIP FLO-41 Precision MIS Delivery SystemBaxter Healthcare Corportation Jan 8, 2020
K192754 — Avenger Radial Head SystemIn2Bones USA, LLC Jan 7, 2020
K192774 — BioCardia 8F Morph DNA Deflectable Guide CatheterBiocardia Jan 7, 2020
K190651 — ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapterErbe Elektromedizin GmbH Jan 7, 2020
K192715 — CRF Radiofrequency Ablation SystemCambridge Interventional, LLC Jan 7, 2020
K190942 — Disposable Powder Free Nitrile Examination Glove, Pink/Black ColorEver Growth (Vietnam) Co. , Ltd. Jan 7, 2020
K191870 — VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc. Jan 7, 2020
K192917 — ViewPoint 6Ge Medical Systems Ultrasound And Jan 6, 2020
K192497 — EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC Jan 6, 2020
K191123 — Multi-unit AbutmentsMedentika GmbH Jan 6, 2020
K193125 — R2P Destination Slender Guiding SheathTerumo Medical Corporation Jan 6, 2020
K193102 — MRIaudio PREM System with MRIviewMriaudio, Inc. Jan 6, 2020
K192412 — SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed HandpieceDentalez, Inc. Jan 6, 2020
K192903 — RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Jan 6, 2020
K192827 — Quadra-PMedacta International S.A. Jan 6, 2020
K191642 — TK Sterile Piston Syringe without NeedleAnhui Tiankang Medical Technology Co., Ltd. Jan 6, 2020
K192696 — TriMed ASET Foot Plating SystemTriMed, Inc. Jan 5, 2020
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