510(k) Clearances in 2020 — Page 2

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 2 of 59)
510(k) clearancesDetails
K192073 — Helix Genetic Health Risk App for late-onset Alzheimer’s diseaseHelix Opco, LLC Dec 23, 2020
K203026 — AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P. Dec 23, 2020
K202882 — AffinityHermes Medical Solutions AB Dec 23, 2020
DEN200016 — EndoRotor DeviceInterscope, Inc. Dec 23, 2020
K201458 — Scrambler Therapy Technology (Model ST-5A)Delta International Services & Logistics S.R.L Dec 23, 2020
K201604 — Plasdent Disposable Barrier Sleeves and Barrier FilmPlasdent Corporation Dec 23, 2020
K203207 — Omnia Medical TiBrid-SAOmnia Medical, LLC Dec 23, 2020
K202061 — Medical Face maskJiangsu Province Jianerkang Medical Dressing Co., Ltd. Dec 23, 2020
DEN190035 — Helix Laboratory PlatformHelix Opco, LLC Dec 23, 2020
K200697 — AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)AtriCure, Inc. Dec 23, 2020
K202320 — CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine SystemBrainlab AG Dec 23, 2020
K202431 — ControlRad Select Model ZControlrad, Inc. Dec 23, 2020
K200610 — Customized Contour ImplantImplantech Associates, Inc. Dec 23, 2020
K203066 — COOLIEF Cooled Radiofrequency Kit AdvancedAvanos Medical, Inc. Dec 22, 2020
K203552 — Rapid RebootRapid Reboot Recovery Products, LLC Dec 22, 2020
K202974 — DenTek Fresh Protect Dental GuardMedtech Products, Inc. Dec 22, 2020
K203447 — iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee ReplacementConformis, Inc. Dec 22, 2020
K201491 — Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. Dec 22, 2020
K202348 — External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. Dec 22, 2020
K200473 — SoloAsisst II, Voice ControlAktormed GmbH Dec 22, 2020
K202849 — Everyway Analog OTC TENS, model N103A/N302Everyway Medical Instruments Co.,Ltd Dec 22, 2020
K201287 — Impulse Interbody Fusion SystemDegen Medical Dec 22, 2020
K202820 — Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd. Dec 22, 2020
K201707 — Opallis, Opallis FlowDentscare Ltda Dec 22, 2020
K201705 — ReVene Thrombectomy CatheterVetex Medical, Ltd. Dec 22, 2020
K203452 — Nano FortiFix® SystemNanovis, LLC Dec 22, 2020
K202159 — actiTENSSublimed Dec 22, 2020
K203504 — Cios FlowSiemens Medical Solutions USA, Inc. Dec 22, 2020
K202229 — AI MetricsAi Metrics, LLC Dec 22, 2020
K201036 — PlaniMax Orthodontic SoftwareChoice Biotech, Inc. Dec 22, 2020
K202211 — Disposable Medical Surgical Face MasksGuangdong Kaidi Garments Co.,Ltd Dec 22, 2020
K203281 — Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-XMedphoton GmbH Dec 22, 2020
K203437 — Serranator PTA Serration Balloon CatheterCagent Vascular, LLC Dec 22, 2020
K202298 — Lucent XP, Lucent XP CurvedSpinal Elements, Inc. Dec 22, 2020
K201910 — EZTrackNeurologic, LLC Dec 22, 2020
K201489 — Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access setArgon Medical Devices, Inc. Dec 22, 2020
K202968 — Da Vinci SP Surgical SystemIntuitive Surgical, Inc. Dec 22, 2020
K201643 — ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC Dec 22, 2020
K203476 — CAPERE Thrombectomy SystemVascular Medcure, Inc. Dec 22, 2020
K200908 — iSMILE3D Diagnostix, Inc. Dec 22, 2020
K202979 — MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal UltraLode B.V. Dec 21, 2020
K192308 — Wu's Electrical ScooterWu'S Tech Co., Ltd. Dec 21, 2020
K201996 — Monocryl Plus Antibacterial SutureETHICON, Inc. Dec 21, 2020
K201113 — Resascope RS-01/BAdvanced Medical Systems Group Srl Dec 21, 2020
K202782 — num Vapocoolant623 Medical, LLC Dec 21, 2020
K203445 — Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. Dec 21, 2020
K203178 — Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical) Dec 20, 2020
K201077 — Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs Dec 20, 2020
K202668 — Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable ProteinMedline Industries, Inc. Dec 19, 2020
K202005 — NovoFine Plus 32G Tip x 4 mmNovo Nordisk, Inc. Dec 19, 2020
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