510(k) Clearances in 2023 — Page 56

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 56 of 67)
510(k) clearancesDetails
K222983 — NeuroBlate Fusion-S Software V3.17Monteris Medical, Mar 15, 2023
K221924 — Digital RoutinesGnc Holdings, LLC Mar 15, 2023
K223375 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.Kossan International Sdn Bhd3 Mar 15, 2023
K223760 — ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)Ethicon Endo-Surgery Mar 15, 2023
K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp Mar 15, 2023
K220122 — APEX 6Rf Innovations, Inc. Mar 15, 2023
K222991 — Air Compression Leg Massager (model: EMK-701)Xiamen Emoka Health Science & Technology Co., Ltd. Mar 15, 2023
K223381 — iExaminer System with Panoptic PlusWelch Allyn, Inc. Mar 15, 2023
K220234 — Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. Mar 15, 2023
K212906 — HeartBuds Electronic StethoscopeHeartbuds, LLC Mar 14, 2023
K223137 — Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie ApplicationHearx SA (Pty) , Ltd. Mar 14, 2023
K213247 — JETT PLASMA Medical IICompex, Spol, S.R.O. Mar 14, 2023
K230019 — SofWave SystemSofwave Medical, Ltd. Mar 14, 2023
K223609 — RevCore™ Thrombectomy Catheter.Inari Medical, Inc. Mar 14, 2023
K223753 — Cervical Plate SystemDouble Medical Technology, Inc. Mar 14, 2023
K223464 — Leg and Foot Air Wave Pressure Therapy DeviceZhangzhou Easepal Innovation CO , Ltd. Mar 14, 2023
K223279 — RT Elements (4.0)Brainlab AG Mar 14, 2023
K230145 — ONE-CUFGe Medical Systems Information Technologies, Inc. Mar 14, 2023
K222954 — Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc. Mar 13, 2023
K223350 — Remi Robotic Navigation SystemFusion Robotics, LLC Mar 13, 2023
K221352 — Surgical Face MaskWuhan Huashida Protective Products Co., Ltd. Mar 13, 2023
K223321 — Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC Mar 13, 2023
K222775 — Aarhus Applicator SetVarian Medical Systems, Inc. Mar 13, 2023
K222456 — High Protection Surgical Gown3A Medical Products Co., Ltd. Mar 12, 2023
K213744 — Avoset Infusion Pump SystemEitan Medical , Ltd. Mar 10, 2023
K230349 — Lyra RSV+hMPV AssayQuidel Corporation Mar 10, 2023
K222478 — BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceBecton, Dickinson And Company Mar 10, 2023
K222718 — Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. Mar 10, 2023
K223325 — uMI PanoramaShanghai United Imaging Healthcare Co., Ltd. Mar 10, 2023
K230295 — ATTUNE® Revision ConesDepuy Ireland UC Mar 10, 2023
K221198 — Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mLThermo Fisher Scientific Mar 10, 2023
K221129 — CloudTMS for OCDTeleemg, LLC Mar 10, 2023
K230433 — Arthrex Knotless FiberTak Suture AnchorArthrex, Inc. Mar 10, 2023
K221623 — FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH Mar 10, 2023
K221292 — Uni Knee Resurfacing SystemOverture Resurfacing, Inc. Mar 10, 2023
K220398 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, LLC Mar 10, 2023
K223175 — lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation Mar 10, 2023
K221930 — CEREGLIDE 71 Intermediate CatheterCerenovus, Inc. Mar 9, 2023
K221919 — DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing setsHemodia Sas Mar 9, 2023
K223790 — Huvex Interspinous Fusion SystemDio Medical Corp. Mar 9, 2023
K221700 — AutoPulse NXT Resuscitation SystemZoll Circulation, Inc. Mar 9, 2023
K221816 — Wesper LabWesper, Inc. Mar 9, 2023
K223514 — Spectral Bone MarrowGe Medical Systems, LLC Mar 9, 2023
K222875 — Powered Muscle Stimulator (Model name:MagGraver F200)Nanjing Vishee Medical Technology Co., Ltd. Mar 9, 2023
K223693 — Electric breast pump (model: M5)Shenzhen Lutejiacheng Technology Co., Ltd. Mar 9, 2023
K223432 — Vassallo GT 018 HybridFilmecc Co., Ltd. Mar 9, 2023
K222663 — MultiStage Balloon Dilatation CatheterDongguan TT Medical, Inc. Mar 9, 2023
K222430 — VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN FosfomycinBiomerieux Sa, Inc. Mar 9, 2023
K221373 — Essenz HLMLivanova Deutschland, GmbH Mar 9, 2023
K221934 — CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. Mar 9, 2023
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