510(k) Clearances in 2022 — Page 43

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 43 of 65)
510(k) clearancesDetails
K220411 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions May 13, 2022
K220749 — Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOPUnimax Medical Products Co., Ltd. May 13, 2022
K220429 — Violet Nitrile Powder-Free Patient Examination Glove, Non SterileOne Glove Industrial Sdn Bhd May 13, 2022
K220760 — Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. May 13, 2022
K220115 — ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC May 13, 2022
K213785 — SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate May 13, 2022
K210575 — HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros May 13, 2022
K221099 — Arthrex Self-Punching PushLock Suture AnchorArthrex, Inc. May 13, 2022
K220589 — MAGNETOM Skyra FitSiemens Medical Solutions USA, Inc. May 13, 2022
K213535 — Sterile Safety Hypodermic Needles for Single UseZhejiang Kangkang Medical-Devices Co., Ltd. May 13, 2022
K221144 — PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FGRadisen Co., Ltd. May 13, 2022
K220757 — Argo Knotless SP AnchorConmed Corporation May 13, 2022
K220118 — Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination GlovesKl-Kepong Rubber Products Sdn. Bhd. May 12, 2022
K220430 — CapsuloQuantel Medical May 12, 2022
K220105 — Saige-DxDeepHealth, Inc. May 12, 2022
K220747 — Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd May 12, 2022
K220740 — Power Wheelchair, W5907 (Q50 R Carbon)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd May 12, 2022
K213491 — Universal Pilot Guidance Instrument SystemCtl Medical Corporation May 12, 2022
K220397 — ANSiStim-PPDyansys, Inc. May 12, 2022
K220723 — Hand Trauma Screw SystemSkeletal Dynamics, Inc. May 12, 2022
K213811 — Sterile Hypodermic Syringes for Single UseBerpu Medical Technology Co., Ltd. May 12, 2022
K210937 — Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241Alicn Medical Shenzhen, Inc. May 12, 2022
K213025 — Laser hair growth helmetKam Yuen Plastic Products , Ltd. May 12, 2022
K220738 — Motive Knee WrapCymedica Orthopedics, Inc. May 12, 2022
K220442 — Synguard Nitrile Exam GloveTianjin Aoshang Outdoor Equipment Co., Ltd. May 12, 2022
K221001 — IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd. May 12, 2022
K212620 — Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC May 12, 2022
K220446 — Versana BalanceGE Medical Systems Ultrasound And Primary Care Diagnostics May 11, 2022
K213177 — Plus Medical Cover GownFoshan Nanhai Plus Medical Co, Ltd. May 11, 2022
K220587 — Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. May 11, 2022
K220250 — Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd. May 11, 2022
K213001 — Procedure Mask, Surgical MaskA Plus International, Inc. May 11, 2022
K212909 — VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStripsMacromedics BV May 11, 2022
K211152 — Durex Condom with BenzocaineRb Health (Us), LLC May 11, 2022
K213299 — Wireless EEG SystemPascall Systems, Inc. May 11, 2022
K220662 — Disposable Barrier SleevesPremium Plus (Dongguan) Limited May 11, 2022
K213004 — Needle Free ConnectorMedcaptain Life Science Co., Ltd. May 10, 2022
K220727 — inHEART MODELSInheart, Sas May 10, 2022
K220428 — Black Nitrile Powder-Free Patient Examination Glove, Non-SterileOne Glove Industrial Sdn Bhd May 10, 2022
K212519 — Overjet Caries AssistOverjet, Inc. May 10, 2022
K220711 — SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation May 10, 2022
K220427 — White Nitrile Powder-Free Patient Examination Glove, Non SterileOne Glove Industrial Sdn Bhd May 10, 2022
K221059 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)Conformis, Inc. May 10, 2022
K214008 — Dental diode laserShenzhen Soga Technology Co., Ltd. May 10, 2022
K221136 — RadiForce MX243WEizo Corporation May 10, 2022
K210585 — BD CTGCTV2Becton, Dickinson And Company May 10, 2022
K203527 — Immunalysis Tapentadol Urine HEIALmmunalysis Corporation May 9, 2022
K220414 — VersaCross Connect Transseptal DilatorBaylis Medical Company, Inc. May 9, 2022
K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemCepheid May 9, 2022
K213022 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LEDCefla S.C. May 9, 2022
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