510(k) Clearances in 2022 — Page 59

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 59 of 65)
510(k) clearancesDetails
K212545 — FlexitSystem Knee osteotomy systemNeosteo Feb 11, 2022
K202728 — Action Trackchair HawkAction Manufacturing, Inc. Feb 10, 2022
K213632 — Instylla Delivery KitInstylla, Inc. Feb 10, 2022
K202234 — NervAlign Nerve CuffRenerve, Ltd. Feb 10, 2022
K212971 — NPsealGuard Medical, Inc. Feb 10, 2022
K211570 — Zeolite Hemostatic GauzeHangzhou Zeo-Innov Life Technology Co., Ltd. Feb 10, 2022
K203811 — GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited Feb 10, 2022
K202926 — Micro CatheterShanghai Heartcare Medical Technology Co., Ltd. Feb 10, 2022
K211327 — Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology CathetersCathRx, Ltd. Feb 10, 2022
K220007 — Pure-Vu EVS SystemMotus GI Medical Technologies , Ltd. Feb 10, 2022
K211617 — InfrascannerInfrascan, Inc. Feb 9, 2022
K212167 — R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireVascular Solutions, LLC Feb 9, 2022
K220108 — SDC4K Information Management System with Device and Voice Control PackageStryker Endoscopy Feb 9, 2022
K212705 — Actively Trying Personal Lubricant UnfragranceCC Wellness, LLC Feb 9, 2022
K214011 — Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered DriversMedtronic Sofamor Danek USA, Inc. Feb 9, 2022
K212658 — CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcath Feb 9, 2022
K213573 — PELNAC Wound MatrixGunze Limited Feb 9, 2022
K212213 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid Feb 9, 2022
K213918 — DeGen Navigated InstrumentationDegen Medical Feb 9, 2022
K213313 — Veinoflow SCD (Model: LBTK-M-I 5006)Dalian Labtek Science & Development Co., Ltd. Feb 9, 2022
K213311 — Lucy Breast PumpWillow Innovations, Inc. Feb 9, 2022
K212211 — Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheterVascular Solutions, LLC Feb 9, 2022
K213297 — RedlineJohns Dental Laboratories Feb 9, 2022
K220047 — AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc. Feb 8, 2022
K211530 — PathBuilder Steerable IntroducerShanghai Microport EP Medtech Co., Ltd. Feb 8, 2022
K213058 — O'Star Nitrile Examination Gloves Powder FreeStar Investment And Trade Joint Stock Company Feb 8, 2022
K213165 — RapidIschemaview, Inc. Feb 8, 2022
K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveBiomet, Inc. Feb 7, 2022
K201191 — ELEC-LEDMicro-Nx Co., Ltd. Feb 7, 2022
K220053 — Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIFujifilm Corporation Feb 4, 2022
K212271 — smart-syncNorthh Medical GmbH Feb 4, 2022
K214062 — Radialis PET CameraRadialis, Inc. Feb 4, 2022
K212724 — BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson And Company Feb 4, 2022
K210356 — Noris Medical Dental Implants SystemNoris Medical , Ltd. Feb 4, 2022
K220020 — Cryo 7Zimmer Medizinsysteme GmbH Feb 4, 2022
K213569 — HOLLYWOOD SPECTRA Laser SystemLutronic Corporation Feb 4, 2022
K211417 — F3D-C2 Cervical Stand-Alone SystemCorelink, LLC Feb 4, 2022
K213801 — Veuron-Brain-pAb2Heuron Co., Ltd. Feb 4, 2022
K213777 — Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants Feb 4, 2022
K213938 — Revolution AscendGe Healthcare Japan Corporation Feb 4, 2022
K212721 — Genex Bone Graft SubstituteBiocomposites, Ltd. Feb 4, 2022
K212774 — VenSure LightGuideIntersect Ent. Feb 4, 2022
K220098 — Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc. Feb 4, 2022
K212419 — Magnifico Open, Magnifico MSKEsaote, S.P.A. Feb 4, 2022
K220070 — MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact LensCooperVision, Inc. Feb 4, 2022
K212849 — VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)Biomérieux, Inc. Feb 4, 2022
K212654 — Micro C Medical Imaging System, M01Oxos Medical, Inc. Feb 4, 2022
K220071 — Soniquence Reusable Neutral PlateSoniquence, LLC Feb 3, 2022
K211822 — LifePath Remote Patient Monitoring PlatformElastic Care Incorporated Feb 3, 2022
K212382 — Ambu® aScope™ Gastro, Ambu® aBox™2Ambu A/S Feb 3, 2022
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