510(k) Clearances in 2023 — Page 24

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 24 of 67)
510(k) clearancesDetails
K231999 — Steriking® LT-Blueline Pouches with Tyvek®Wipak OY Sep 7, 2023
K230644 — Signum opaque FKulzer, LLC Sep 7, 2023
K231828 — Pounce™ SheathSurmodics,Inc. Sep 7, 2023
K230049 — SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUTTtk Healthcare Limited Sep 7, 2023
K230824 — IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)Art Optical Contact Lens, Inc. Sep 6, 2023
K223575 — Phoenix ICON, Phoenix ICON GONeolight, LLC Sep 6, 2023
K230024 — HI-EMT MAGSHAPEBeijing Sano Laser S&T Development Co.,Ltd Sep 6, 2023
DEN230006 — esolutionS4 Medical Corp. Sep 6, 2023
K232482 — MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc. Sep 6, 2023
K230127 — Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatibleMicro-Tech (Nanjing) Co., Ltd. Sep 6, 2023
K231717 — IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022Foshan Jindi Electric Appliance Co., Ltd. Sep 6, 2023
K231819 — Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewInnovate Orthopaedics Limited Sep 5, 2023
K200583 — Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTLKi Mobility, LLC Sep 5, 2023
K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical Diagnostics Sep 5, 2023
K201869 — Ki Power Tilt SystemKi Mobility, LLC Sep 5, 2023
K232361 — Promaxo MRI System IIPromaxo, Inc. Sep 5, 2023
K232691 — PolibondZirkonzahn Srl Sep 5, 2023
K230743 — ICHOR 14F Embolectomy SystemIchor Sep 5, 2023
K221869 — BCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd. Sep 5, 2023
K223684 — F&P 820 Humidification SystemFisher & Paykel Healthcare, Ltd. Sep 5, 2023
K213413 — Hemostatic DressingJiangsu Newvalue Medical Products Co., Ltd. Sep 1, 2023
K230805 — TriMed Clavicle Fixation SystemTriMed, Inc. Sep 1, 2023
K213273 — Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics , Ltd. Sep 1, 2023
K232657 — InnerView LCPerimetrics, Inc. Sep 1, 2023
K230918 — MasterX 800 SeriesMedicatech USA Sep 1, 2023
K223622 — FaceHeart Vitals Software Development Kit (FH vitals SDK)Faceheart Corp. Sep 1, 2023
K231884 — TRIOCLEAR SystemModern Dental Laboratory (Dg) Co., Ltd. Sep 1, 2023
K223674 — eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic Medical Pte. , Ltd. Sep 1, 2023
K232334 — DEKA SIMONEl.En S.P.A. Sep 1, 2023
K231270 — Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc. Sep 1, 2023
K232314 — Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FUJIFILM Healthcare Americas Corporation Sep 1, 2023
K222988 — neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical Sep 1, 2023
K232068 — HyperLight Portable X-ray UnitChangzhou Sifary Medical Technology Co., Ltd. Sep 1, 2023
K230317 — Elos Accurate Hybrid BaseElos Medtech Pinol A/S Sep 1, 2023
K232340 — Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorArthrex, Inc. Sep 1, 2023
K223901 — ApneaRX ProApnea Sciences Coporation Sep 1, 2023
K231047 — UniSyn Molecular Imaging (6-3-1)Convergent Imaging Solutions Sep 1, 2023
K232014 — CONDUIT™ ATP InsertersEnztec Limited Sep 1, 2023
DEN230007 — LightStrike+ (MXSUV1-SL and MXSUV1-FT)Xenex Disinfection Services, Inc. Sep 1, 2023
K232021 — Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd. Sep 1, 2023
K230623 — KITE Distal Fibula KitIntrauma S.P.A Sep 1, 2023
K221601 — MS-39C.S.O. S.R.L. Sep 1, 2023
K231710 — OW100SSoftwave/Trt, LLC Sep 1, 2023
K231626 — OSPREY Closed IV Catheter System (OspreyV2)Skydance Vascular, Inc. Aug 31, 2023
K213271 — MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis Medical Aug 31, 2023
K222563 — BD Kiestra IdentifABecton, Dickinson And Company Aug 31, 2023
K232353 — Powder Free Nitrile Examination Gloves (Black)Shanxi Hongjin Plastic Technology Co., Ltd. Aug 31, 2023
K232287 — RAYSCAN a-Expert3DRay Co., Ltd. Aug 31, 2023
K230578 — Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd. Aug 31, 2023
K223533 — Little Wave Arc; Little Wave FlipKi Mobility, LLC Aug 31, 2023
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