510(k) Clearances in 2020 — Page 54

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 54 of 59)
510(k) clearancesDetails
K192273 — DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro KitDiaDent Group International Feb 7, 2020
K200117 — Trevo NXT ProVue RetrieverStryker Feb 7, 2020
K183688 — i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point Of Care, Inc. Feb 7, 2020
K193154 — 3M Attest Super Rapid 5 Steam-Plus Challenge Pack3M Company Feb 7, 2020
K191298 — i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point Of Care, Inc. Feb 7, 2020
K190259 — Vesta RF CannulaBiomerics Feb 7, 2020
K191347 — Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co. , Ltd. Feb 7, 2020
K193129 — Yukon OCT Spinal SystemK2M, Inc. Feb 7, 2020
K193103 — NeoBase 2 Non-derivatized MSMS KitPerkinelmer, Inc. Feb 7, 2020
K191411 — Ah!Yes Ob Coco Personal LubricantBio-Tech Lubricants, Ltd. Feb 6, 2020
K193461 — MectaLock All-Suture AnchorsMedacta International S.A. Feb 6, 2020
K191890 — Elos Accurate Customized AbutmentElos Medtech Pinol A/S Feb 6, 2020
K192757 — VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20Vitalconnect, Inc. Feb 6, 2020
K191571 — UV Radiation Treatment SystemXuzhou Yongkang Electronic Science Technology Co., Ltd. Feb 6, 2020
K191290 — Ancora Nerve Block Catheter SetAncora Medical Technology Feb 6, 2020
K190800 — Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsCosmed Srl Feb 6, 2020
K192002 — Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc. Feb 6, 2020
K193521 — Steerable Plateau TiLife Spine, Inc. Feb 6, 2020
K193610 — BreathID Smart SystemExalenz Bioscience , Ltd. Feb 6, 2020
K191529 — da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical Feb 6, 2020
K192806 — DENTCA Crown and BridgeDentca, Inc. Feb 5, 2020
K192127 — Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings Feb 5, 2020
K200170 — SpineNet SSP SystemSpinenet, LLC Feb 5, 2020
K200038 — Endosee SystemCooperSurgical, Inc. Feb 5, 2020
K192785 — OptiScanner® 5000 Glucose Monitoring SystemOptiscan Biomedical Corporation Feb 5, 2020
K180935 — Infinity / Infinity Cross Flex Dental SystemsOlsen Industria E Comercio S.A. Feb 5, 2020
K193396 — PERLA® TL posterior osteosynthesis systemSpineart Feb 5, 2020
K200050 — Akesis Galaxy RTxAkesis, Inc. Feb 4, 2020
K193398 — Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. Feb 4, 2020
K191532 — The Caterpillar and Caterpillar Micro Arterial Embolization DevicesC.R. Bard, Inc. Feb 4, 2020
K193320 — KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc. Feb 4, 2020
K191832 — Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)Kurin, Inc. Feb 4, 2020
K183148 — OKLand Patient Return Electrode PadAuckland Medical Polymer(Tianjin) Co., Ltd. Feb 4, 2020
K192688 — s-Clean SQ-SL Implant System RegularDentis Co., Ltd. Feb 4, 2020
K193324 — Motion Correction SystemKineticor, Inc. Feb 4, 2020
K190966 — Katalyst Training SystemKatalyst, Inc. Feb 3, 2020
K190842 — Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd. Feb 3, 2020
K192579 — X-Guide Surgical Navigation SystemX-Nav Technologies, LLC Feb 3, 2020
K190962 — Bella-muU-Needle B.V. Feb 3, 2020
K193128 — Mako Total Hip ApplicationMako Surgical Corp. Feb 2, 2020
K200030 — Optima Coil SystemBalt USA, LLC Feb 1, 2020
K193480 — BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. Jan 31, 2020
K193257 — ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Jan 31, 2020
K193192 — Tamper Evident CapInternational Medical Industries, Inc. Jan 31, 2020
K200018 — HAD1717MCH&Abyz Jan 31, 2020
K192462 — syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. Jan 31, 2020
K192234 — ActiPatchBioelectronics Corporation Jan 31, 2020
K191330 — Arc EnterocuffBoddingtons Plastics, Ltd. Jan 31, 2020
K193258 — ProLift Expandable SystemLife Spine, Inc. Jan 31, 2020
K192163 — TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. Jan 31, 2020
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