510(k) Clearances in 2021 — Page 23

3,023 510(k) clearances total

Browse FDA 510(k) clearances granted in 2021. RegDataLab tracks 3,023 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2021 (page 23 of 61)
510(k) clearancesDetails
K210047 — Stiletto Extended Dwell CatheterPiper Access, LLC Aug 27, 2021
K203696 — RBkneeRadiobotics Aps Aug 27, 2021
K210373 — Clear AlignersShenzhen Yinuo Dental Technology Co.Ltd Aug 27, 2021
K212004 — MyoSPECT, MyoSpect ESGE Healthcare Aug 27, 2021
K212345 — AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. Aug 27, 2021
K210676 — XSTAT 30 PouchRevmedx, Inc. Aug 27, 2021
K211373 — SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO SoftwareSiemens Medical Solutions USA, Inc. Aug 27, 2021
K202752 — AXS Vecta 46 Intermediate CatheterStryker Neurovascular Aug 27, 2021
K210502 — Trevo NXT ProVue RetrieverStryker Neurovascular Aug 27, 2021
K202861 — Needle StimulatorWuxi Jiajian Medical Instrument Co., Ltd. Aug 27, 2021
K210122 — Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd. Aug 27, 2021
DEN200064 — Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical, Inc. Aug 27, 2021
K202952 — Amber Mill Q Series & Amber Mill Direct SeriesHass Corp. Aug 26, 2021
K210898 — Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)Tangshan Lanhai Medical Supplies Co., Ltd. Aug 26, 2021
K212355 — Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, LargeCheckpoint Surgical Aug 26, 2021
K211634 — Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc. Aug 26, 2021
K210991 — Disposable Sterile Syringe, Disposable Sterile Syringe with NeedleGuangdong Antmed Co., Ltd. Aug 26, 2021
K210288 — Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd. Aug 26, 2021
K212048 — Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)Intuitive Surgical, Inc. Aug 26, 2021
K211240 — ViperCross Support CathetersCardiovascular Systems, Inc. Aug 26, 2021
K202831 — The iMask Child's Face MaskPac-Dent, Inc. Aug 26, 2021
K210745 — Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc. Aug 26, 2021
K200230 — Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc. Aug 26, 2021
K202802 — TT Electric Breast Pump, TT Double Electric Breast PumpWuxi Xinzhongrui Baby Supplies Co., Ltd. Aug 26, 2021
K200748 — Visby Medical Sexual HealthVisby Medical Aug 26, 2021
K210131 — ComfortGuard Surgical Isolation GownGri-Alleset, Inc. Aug 26, 2021
K211362 — SCAR 3El.En Electronic Engineering Spa Aug 25, 2021
K211609 — ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC Aug 25, 2021
K211616 — ExcelsiusHubGlobus Medical, Inc. Aug 25, 2021
K212051 — RFA-1717DIG, RFA-1717DICAstel, Inc. Aug 25, 2021
K210790 — Lateralized and Augmented BaseplatesFx Shoulder USA, Inc. Aug 25, 2021
K210936 — Elvie StrideChiaro Technology Limited Aug 25, 2021
K211444 — CellFX SystemPulse Biosciences, Inc. Aug 25, 2021
K212323 — Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. Aug 25, 2021
K210838 — PROWLER SELECT PLUS; PROWLER EXMedos International SARL Aug 25, 2021
K203344 — Premilled Titanium Block SystemInnobiosurg Co., Ltd. Aug 25, 2021
K202148 — E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)Fit-Pro , Ltd. Aug 25, 2021
K210792 — Auxein Nailing SystemAuxein Medical Private Limited Aug 25, 2021
K211500 — AMSCO 600 Medium Steam SterilizerSTERIS Corporation Aug 25, 2021
K211451 — Disposable Surgical Mask (non sterile)Qinhuangdao Taizhi Medical Technology Co., Ltd. Aug 25, 2021
K203357 — HVT 2.0Vapotherm, Inc. Aug 25, 2021
K212134 — Diagnostic X-ray System/PLX5200ANanjing Perlove Medical Equipment Co., Ltd. Aug 25, 2021
K202916 — Balloon Guiding CatheterShanghai Heartcare Medical Technology Co., Ltd. Aug 25, 2021
K201157 — Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc. Aug 24, 2021
K211515 — Nitrile Examination GlovesBeijing Reagent Latex Products Co., Ltd. Aug 24, 2021
K210844 — DreamWear Silicone Pillows MaskRespironics, Inc. Aug 24, 2021
K211516 — Disposable Vinyl Nitrile Synthetic Gloves Powder FreeTangshan Hongyun Plastic Products Co., Ltd. Aug 24, 2021
K203739 — ELAN 4 Electro Motor SystemAesculap, Inc. Aug 24, 2021
K210674 — Shoulder PacemakerNcs Lab Srl Aug 24, 2021
K210619 — SKR 3000Konica Minolta, Inc. Aug 24, 2021
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