510(k) Clearances in 2022 — Page 57

3,209 510(k) clearances total

Browse FDA 510(k) clearances granted in 2022. RegDataLab tracks 3,209 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2022 (page 57 of 65)
510(k) clearancesDetails
K211798 — Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc. Feb 24, 2022
K213599 — SuperLineDentium Co., Ltd. Feb 23, 2022
K212786 — LevaLap Laparoscopic Access DeviceCore Access Surgical Technologies, Inc. Feb 23, 2022
K220197 — Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. Feb 23, 2022
K213654 — NuVasive Reline Cervical SystemNu Vasive, Incorporated Feb 23, 2022
K212668 — Sclerotherapy NeedleZhejiang Chuangxiang Medical Technology Co., Ltd. Feb 23, 2022
K211965 — StimRouter Neuromodulation SystemBioness, Inc. Feb 23, 2022
K212378 — Arsenal Ankle Plating SystemTrilliant Surgical Feb 23, 2022
K214102 — Glidewell Appliance Resin, Hard/SoftPrismatik Dentalcraft, Inc. Feb 23, 2022
DEN210034 — ONE Male CondomGlobal Protection Corp. Feb 23, 2022
K220003 — EzOrtho v1.3Ewoosoft Co., Ltd. Feb 23, 2022
K213991 — Enbio SEnbio Group AG Feb 22, 2022
K213392 — INLIANT Surgical Navigation SystemNavigate Surgical Technologies, Inc. Feb 22, 2022
K220471 — VALO X, VALO X Accessory LensesUltradent Products, Inc. Feb 22, 2022
K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical SutureETHICON, Inc. Feb 22, 2022
K211686 — Flexible Video-Choledo-Cysto-Ureteroscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd. Feb 22, 2022
K213500 — TMG Nitrile Powder Free Examination GloveThai Medical Glove Co., Ltd. Feb 21, 2022
K203548 — EndoArmor™ + Surgical GownBoston Scientific Corporation Feb 21, 2022
K213548 — Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with ChemotherapyMercator Medical (Thailand), Ltd. Feb 21, 2022
K220232 — Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, OrangeMegine Industries Sdn Bhd Feb 20, 2022
K213724 — Medical Surgical MaskHunan Zhenheyikang Medical Instrument Co., Ltd. Feb 20, 2022
K212863 — Surgical Face MaskTaiwan Comfort Champ Manufacturing Co., Ltd. Feb 19, 2022
K214110 — Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy DrugsMah Sing Healthcare Sdn. Bhd. Feb 19, 2022
K212935 — Air Pressure Foot MassagerXiamen Simo Electronic Co., Ltd. Feb 19, 2022
K212998 — Powder Free Nitrile Examination Gloves (White, Blue and Black)Alcatron Gloves Factory Feb 19, 2022
K213600 — Medical nitrile examination gloves (Model: SH001)Jiangxi Sanhao Medical Instruments Co.,Ltd Feb 19, 2022
K213091 — Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited Feb 19, 2022
K212366 — Heartland Health Surgical MaskHeartland Health Products Feb 19, 2022
K213286 — EONS Nitrile Examination Gloves Powder FreeEons Gloves (Thailand) Co., Ltd. Feb 19, 2022
K213912 — Disposable Medical Nitrile Examination GlovesJiangsu Maolin Medical Technology Co., Ltd. Feb 19, 2022
K201510 — Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V. Feb 18, 2022
K213057 — ExamVue DuoJpi Healthcare Co, Ltd. Feb 18, 2022
K211746 — Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd. Feb 18, 2022
K212447 — SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test MidstreamHangzhou Sejoy Electronics & Instruments Co., Ltd. Feb 18, 2022
K213079 — Ear Thermometer, Model ET001Guangzhou Berrcom Medical Device Co., Ltd. Feb 18, 2022
K213634 — Vinyl/Nitrile Blend Exam GloveDezhou Hengchang Medical Technology Co., Ltd. Feb 18, 2022
K212212 — Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions Feb 18, 2022
K213688 — Nitrile Examination Gloves (Model: ZMG1351)Wuhan Zonsen Medical Products Co., Ltd. Feb 18, 2022
K213440 — Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy DrugsLuliang Hongruida Health Protection Technology Co., Ltd. Feb 18, 2022
K213319 — Viz ANEURYSM, Viz ANXViz. Ai, Inc. Feb 18, 2022
K202644 — AcetaminophenSekisui Diagnostics P.E.I., Inc. Feb 18, 2022
K212627 — True Tulip, True M.I.S.Innovative Surgical Designs, Inc. Feb 18, 2022
K213999 — Deep Learning Image ReconstructionGe Medical Systems, LLC Feb 18, 2022
K213306 — Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy DrugsZibo Sinocare Plastic Products Co., Ltd. Feb 18, 2022
K213503 — Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35EShenzhen AOJ Medical Technology Co., Ltd. Feb 18, 2022
K214003 — Dental Zirconia Pre-shaded BlockShenzhen Yurucheng Dental Materials Co., Ltd. Feb 18, 2022
K214005 — Zirconia Dental CeramicsShenzhen Yurucheng Dental Materials Co., Ltd. Feb 18, 2022
K220162 — Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, AlternariaHycor Biomedical Feb 18, 2022
K212586 — Amazing+Amazing Rubber Products Pvt, Ltd. Feb 17, 2022
K210864 — Safety Pen NeedleSandstone Medical (Suzhou), Inc. Feb 17, 2022
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