510(k) Clearances in 2022 — Page 3

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 3 of 65)
510(k) clearancesDetails
K221031 — Arthrex DualCompression Hindfoot Fusion Nail Implant SystemArthrex, Inc. Dec 20, 2022
K221904 — EK12 V2 AlgorithmGe Medical Systems Information Technologies, Inc. Dec 20, 2022
K220517 — IBS SystemInnobiosurg Co., Ltd. Dec 20, 2022
K222896 — AirRayPoskom Co., Ltd. Dec 20, 2022
K223294 — SpineJack® Expansion KitStryker Instruments Dec 20, 2022
K222808 — Penumbra System (Reperfusion Catheter RED 43)Penumbra, Inc. Dec 20, 2022
K222358 — Indigo Aspiration System - Lightning FlashPenumbra, Inc. Dec 20, 2022
K221775 — LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V. Dec 20, 2022
K221039 — Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20YShenzhen AOJ Medical Technology Co., Ltd. Dec 20, 2022
K221011 — AI.ME SystemVenus Concept USA, Inc. Dec 20, 2022
K221735 — Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc. Dec 20, 2022
K222405 — Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A. Dec 20, 2022
K221004 — HOPKINS TelescopesKarl Storz Endoscopy America, Inc. Dec 20, 2022
K223140 — AEON-C™ Stand Alone SystemDio Medical, Inc. Dec 20, 2022
K222308 — Al Smile AlignerNanjing Jiahe Dental Technology Co., Ltd. Dec 20, 2022
K221070 — DP4 Microneedling deviceEquipmed USA, LLC Dec 20, 2022
K221926 — Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. Dec 20, 2022
K222217 — ViewFlex Xtra Reprocessed ICE CatheterABBOTT MEDICAL Dec 19, 2022
K222213 — Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)Unimed Medical Supplies, Inc. Dec 19, 2022
K213196 — MARVEL™ Growing RodsGlobus Medical, Inc. Dec 19, 2022
K221351 — Mechanical GuidewireBaylis Medical Company, Inc. Dec 19, 2022
K214076 — EsCemSpident Co., Ltd. Dec 19, 2022
K222919 — GORE® ENFORM BiomaterialW. L. Gore And Associates, Inc. Dec 19, 2022
K221896 — BreathID Hp SystemMeridian Bioscience Israel , Ltd. Dec 19, 2022
K213653 — 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEMSolco Biomedical Company India Private Limited Dec 19, 2022
K220881 — INOUE BALLOON AToray Industries, Inc. Dec 18, 2022
K220928 — Overjet Calculus AssistOverjet, Inc. Dec 16, 2022
K223251 — Hexanium PLIFSpinevision, S.A.S. Dec 16, 2022
K222502 — KLICK (VARIANTS: POWER, RACE, MONSTER)Klaxon Mobility GmbH Dec 16, 2022
K220036 — Wellead Ureteral CatheterWell Lead Medical Co., Ltd. Dec 16, 2022
K220554 — Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd. Dec 16, 2022
K213984 — Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)Shenzhen Zhengkang Technology Co., Ltd. Dec 16, 2022
K220052 — Copan FecalSwab Collection, Transport and Preservation SystemCopan Italia Spa Dec 16, 2022
K223153 — Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. Dec 16, 2022
K223243 — BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ LancetsBecton, Dickinson And Company Dec 16, 2022
K213601 — Surgical MaskWuhan Zonsen Medical Products Co., Ltd. Dec 16, 2022
K220010 — Daylily Single Use Sterile Embryo Transfer CatheterShanghai Horizon Medical Technology Co., Ltd. Dec 16, 2022
K212559 — CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH Dec 16, 2022
K223268 — BrainInsightHyperfine, Inc. Dec 16, 2022
K213110 — AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorAuxein Medical Private Limited Dec 16, 2022
K222275 — Saige-DensityDeepHealth, Inc. Dec 16, 2022
K222608 — Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WSTuttnauer , Ltd. Dec 16, 2022
K223237 — SofWave SystemSofwave Medical, Ltd. Dec 16, 2022
DEN220012 — Tornier Pyrocarbon Humeral HeadTornier S.A.S. Dec 16, 2022
K222820 — BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities Dec 16, 2022
K222798 — Rejoni Intrauterine CatheterRejoni, Inc. Dec 16, 2022
K223334 — Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Devices Co., Ltd. Dec 16, 2022
K223184 — Phantom Metatarsal Shortening SystemParagon 28, Inc. Dec 16, 2022
K220281 — multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC Dec 16, 2022
K220873 — Perceptive electric dental motor and control unitLares Research Dec 15, 2022
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