510(k) Clearances — Page 199

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 199 of 3,525)
ClearancesDetails
K232413 — Fusion Robotic Navigation SystemAlphatec Spine, Inc. Sep 8, 2023
K223848 — Intrisound™ Tuned Lumen® 155 Hearing AidsTuned , Ltd. Sep 8, 2023
K223621 — DeepXrayAlpha Intelligence Manifolds, Inc. Sep 8, 2023
K230661 — Zeta Cranial Navigation SystemZeta Surgical Sep 8, 2023
K232426 — Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) InsertsConformis, Inc. Sep 8, 2023
K230535 — KARL STORZ Urological Laser AccessoriesKarl Storz SE & CO. KG Sep 8, 2023
K231729 — Sterile syringes for single use with/without needleWepon Medical Technology Co., Ltd. Sep 8, 2023
K232400 — VariSeed (v10)Varian Medical Systems Sep 8, 2023
K213510 — IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MASiemens Healthcare Diagnostics Products, Ltd. Sep 8, 2023
K231284 — OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc. Sep 8, 2023
K231720 — Sterile Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd. Sep 8, 2023
K230890 — ISE ElectrodesRandox Laboratories, Ltd. Sep 8, 2023
K231335 — Cleerly ISCHEMIACleerly, Inc. Sep 8, 2023
K232414 — Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc. Sep 8, 2023
K231141 — STarFix Designer Software C0265FHC, Inc. Sep 8, 2023
K231146 — AliTightAlic Iotech, LLC Sep 8, 2023
K232457 — Q-FIX ULTRA All-Suture AnchorSmith & Nephew Sep 8, 2023
K231471 — Air/Water Bottle Tubing, CO2 Source TubingZhejiang Chuangxiang Medical Technology Co., Ltd. Sep 8, 2023
K231240 — MaxTack™ Motorized Fixation DeviceCovidien Sep 8, 2023
K232166 — PreXion3D ExpeditionPrexion Corporation Sep 8, 2023
K230310 — STAT Medical Device Lancing SystemStat Medical Devices Sep 8, 2023
K223827 — FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01Fujifilm Corporation Sep 8, 2023
K222823 — AeroDVx Arm SystemSun Scientific, Inc. Sep 7, 2023
K232389 — Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation Sep 7, 2023
K231800 — IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9Shenzhen Qianyu Technology Co., Ltd. Sep 7, 2023
K232443 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc. Sep 7, 2023
K231687 — Gradual Dental Zirconia BlankLiaoning Upcera Co., Ltd. Sep 7, 2023
K231207 — CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc. Sep 7, 2023
K231542 — Digital Blood Pressure Monitor WBP SeriesWeony (Shenzhen) Technology Co., Ltd. Sep 7, 2023
K221743 — Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical ElectrodesJiangsu Bonss Medical Technology Co., Ltd. Sep 7, 2023
K230649 — Arm Blood Pressure MonitorAlicn Medical Shenzhen, Inc. Sep 7, 2023
K231996 — Steriking® LT-Blueline Pouches with Tyvek®Wipak OY Sep 7, 2023
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
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