510(k) Clearances in 2020 — Page 3

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 3 of 59)
510(k) clearancesDetails
K201606 — LacriJet®Fci (France Chirurgie Instrumentation) Sas Dec 18, 2020
K202361 — UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC Dec 18, 2020
K203551 — Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation Dec 18, 2020
K202006 — ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation SystemArthroCare Corporation Dec 18, 2020
K201555 — EchoGo ProUltromics, Ltd. Dec 18, 2020
K201075 — BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV CatheterBecton, Dickinson And Company Dec 18, 2020
K202412 — ClearRT Helical kVCT for the Radixact Treatment Delivery SystemAccuray Incorporated Dec 18, 2020
K203172 — MOSAIQ Oncology Information SystemElekta Solutions AB Dec 18, 2020
K202749 — ADAPT for Gamma3Stryker GmbH Dec 18, 2020
K201185 — microINR SystemIline Microsystems, S.L. Dec 18, 2020
K201250 — SQuEEZ SoftwareCardiowise, Inc. Dec 18, 2020
K202812 — IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. Dec 18, 2020
K191978 — Fever GardeHubdic Co., Ltd. Dec 18, 2020
K202345 — FlowTriever Retrieval/Aspiration SystemInari Medical Dec 18, 2020
K203461 — Aesculap Caiman 12 Seal and Cut Technology SystemAesculap, Inc. Dec 18, 2020
K203162 — Advanix Biliary Stent with NaviFlex RX Delivery SystemBoston Scientific Corporation Dec 18, 2020
K203125 — Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc. Dec 18, 2020
K202026 — Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC Dec 18, 2020
K201980 — Infrared ThermometerContec Medical Systems Co.,Ltd Dec 18, 2020
K203126 — S10 KirraResmed Pty , Ltd. Dec 18, 2020
K203222 — PERLA TL Posterior Osteosynthesis SystemSpineart Dec 17, 2020
K201905 — SMR 140° Reverse Humeral BodyLima Corporate S.P.A. Dec 17, 2020
K202925 — KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc. Dec 17, 2020
K201919 — Blue Sky Bio TADBlue Sky Bio, LLC Dec 17, 2020
K203303 — Emprint SX Ablation Platform with Thermosphere TechnologyCovidien, LLC Dec 17, 2020
K203163 — ARx Illiac Spinal Screw SystemLife Spine, Inc. Dec 17, 2020
K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemAcist Medical Systems, Inc. Dec 17, 2020
K201594 — Primelase ExcellenceHigh Technology Products S.L.U Dec 17, 2020
K201165 — In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp. Dec 17, 2020
K200264 — Exofin High Viscosity Topical Skin AdhesiveChemence Medical, Inc. Dec 17, 2020
K192770 — S dispensing lineAea Srl Dec 17, 2020
K201081 — AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V. Dec 17, 2020
K200346 — Wrist Type Blood Pressure MonitorAvita Corporation Dec 17, 2020
K200342 — Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804LOlympus Medical Systems Corp. Dec 17, 2020
K190217 — Aidite PMMAAidite (Qinhuangdao) Technology Co., Ltd. Dec 17, 2020
K200730 — pjur WOMAN Nude pjur med SENSITIVE glidePjur Group Luxembourg S.A. Dec 17, 2020
K200857 — Electric wheelchair (Model: S7012)Dongguan Prestige Sporting Goods Co., Ltd. Dec 17, 2020
K203349 — Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC Dec 16, 2020
K200291 — CREED™ Cannulated ScrewsGlw Medical, Inc. Dec 16, 2020
K202095 — CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. Dec 16, 2020
K203180 — Arthrex DynaNite Nitinol StaplesArthrex, Inc. Dec 16, 2020
DEN200035 — BEAR (Bridge-Enhanced ACL Repair) ImplantMiach Orthopaedics, Inc. Dec 16, 2020
K201213 — Pasteur Pipette 3mL, Pasteur Pipette 1mLHertart Aps Dec 16, 2020
K200549 — Lucero Medical Cervical Cage SystemLucero Medical, LLC Dec 16, 2020
K203414 — DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate SystemDePuy Synthes Dec 16, 2020
K202029 — Medical Surgical MaskBeijing Biosis Healing Biolog Ical Technology Co., Ltd. Dec 16, 2020
K202028 — dermalux Flex MDAesthetic Technology, Ltd. Dec 16, 2020
K201031 — NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc. Dec 16, 2020
K201509 — Disposable Stone Extraction basketHangzhou AGS MedTech Co., Ltd. Dec 16, 2020
K202289 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)Stryker GmbH Dec 16, 2020
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