510(k) Clearances in 2021 — Page 3

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 3 of 61)
510(k) clearancesDetails
K212715 — Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC Dec 20, 2021
K213531 — TR BAND Radial Compression DeviceTerumo Medical Corporation Dec 20, 2021
K202568 — Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A. Dec 20, 2021
K213275 — EchoGo Core (2.0)Ultromics Limited Dec 20, 2021
K213076 — AspenMed+Aspen Glove Sdn. Bhd. Dec 20, 2021
K210559 — ATOZ Mini-ScrewMk Meditech, Inc. Dec 19, 2021
K212932 — Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet TrayNobel Biocare Services AG Dec 18, 2021
K213048 — Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)Huayuan Medical Technology(Shangqiu) Co., Ltd. Dec 18, 2021
K211624 — USA Gloves Nitrile Powder Free Exam GlovesUsa Gloves Dec 18, 2021
K213051 — Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)Yunnan Huazhiyuan Medical Technology Co., Ltd. Dec 18, 2021
K211457 — Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)Ammex Corporation Dec 18, 2021
K203424 — Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2Qura S.R.L Dec 17, 2021
K211172 — Single Use Electrosurgical Knife with Fluid Pump SystemMicro-Tech (Nanjing) Co., Ltd. Dec 17, 2021
K213627 — RF Vapor SystemAqua Medical, Inc. Dec 17, 2021
K193081 — Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection KitRheonix, Inc. Dec 17, 2021
K213397 — InkSpace Imaging Pediatric Body ArrayInkspace Imaging, Inc. Dec 17, 2021
K212340 — EMBOGUARD Balloon Guide CatheterNeuravi Limited Dec 17, 2021
K203821 — Donagamex Blue Performance Protective GownDong Nai Garment Corporation (Donagamex) Dec 17, 2021
K210825 — Revitive Medic Coach (Model Number 5575AQ)Actegy , Ltd. Dec 17, 2021
K211209 — Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination GlovesHycare International Co., Ltd. Dec 17, 2021
K210077 — MED RF 4000F Care Systems USA, LLC Dec 17, 2021
K212872 — Avenger Radial Head SystemIn2Bones USA, LLC Dec 17, 2021
K210102 — Topwide Surgical Face MaskTopwide (Hubei) Medical Products Manufacturer Dec 17, 2021
K200943 — Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC Dec 17, 2021
K213644 — Arthrex Knotless Mini TightRopesArthrex, Inc. Dec 17, 2021
K203695 — NObreath®Bedfont Scientific, Ltd. Dec 17, 2021
K210914 — Sterile Syringe for Single UseJiangsu Suyun Medical Material Co., Ltd. Dec 17, 2021
K213381 — Physica systemLima Corporate S.P.A. Dec 17, 2021
K212059 — Surgical Face MaskZhongshan Saifute Labor Protective Articles Co., Ltd. Dec 17, 2021
K210931 — Libby IAAA v1.0Dyad Medical, Inc. Dec 17, 2021
K213715 — Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex editionGe Medical Systems, LLC Dec 17, 2021
K210871 — PDO Max Suture with Dual NeedlePdo Max, Inc. Dec 17, 2021
K211531 — Cordless Prophy System, Model: i-PolishGuilin Woodpecker Medical Instrument Co., Ltd. Dec 17, 2021
K213733 — Ponto 5 SuperPowerOticon Medical AB Dec 16, 2021
K212985 — 6MP Color LCD Monitor CL-S600Jvckenwood Corporation Dec 16, 2021
K211217 — Profound MatrixCandela Corporation Dec 16, 2021
K212630 — Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, SoloEllex Medical Pty, Ltd. Dec 16, 2021
K212420 — Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion AngioBrainlab AG Dec 16, 2021
K212645 — ATAt Glove Engineering Sdn. Bhd Dec 16, 2021
K211378 — LM Surgical Mask Level 3, LM Surgical Mask Level 2,Liberty Mask, LLC Dec 16, 2021
K213628 — VBrainVysioneer, Inc. Dec 16, 2021
K213916 — ArchForm Orthodontic Software SystemArchform, Inc. Dec 16, 2021
K213463 — NightOwlEctosense NV Dec 16, 2021
K212898 — Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy DrugsRimba Glove Snd Bhd Dec 16, 2021
K211471 — Balanced Knee System UniOrtho Development Corporation Dec 16, 2021
K210355 — Surgical Gown, Model: surgical gown-hp-3Weihai Dishang Medical Technology Co., Ltd. Dec 16, 2021
K202803 — Activmotion S DTONewclip Technics Dec 16, 2021
K212402 — MIVI Q Distal Access CatheterMivi Neuroscience, Inc. Dec 16, 2021
K202818 — Voyant Fine Fusion Device (EB230)Applied Medical Dec 16, 2021
K213020 — IPL hair removal machineShenzhen Borria Technology Co., Ltd. Dec 16, 2021
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