510(k) Clearances in 2023 — Page 10

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 10 of 67)
510(k) clearancesDetails
K232533 — ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas Nov 16, 2023
K232753 — EXPD 4343D; EXPD 3643DDRTECH Corporation Nov 16, 2023
K230463 — NSite Scoliosis Assessment AppNsite, Inc. Nov 15, 2023
K232841 — Axial3D InsightAxial Medical Printing Limited Nov 15, 2023
DEN200070 — Simple 2 TestLetsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) Nov 15, 2023
K231012 — CoolSeal TrinityBolder Surgical, LLC Nov 15, 2023
K231818 — METIC™- Airway Balloon CatheterM/S Meril Life Sciences Pvt. , Ltd. Nov 15, 2023
K232973 — Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc. Nov 15, 2023
K223414 — Curing Light, Model: MaxCure 9Guilin Refine Medical Instrument Co., Ltd. Nov 15, 2023
K231852 — BinkieRTPapricalab Nov 15, 2023
K230856 — BrainSpec Core™ SoftwareBrainspec, Inc. Nov 14, 2023
K232092 — Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USA Nov 14, 2023
K233434 — Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)Prismatik Dentalcraft, Inc. Nov 14, 2023
K232494 — MAGNETOM Avanto fit; MAGNETOM Skyra fitSiemens Medical Solutions USA, Inc. Nov 14, 2023
K231097 — Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant SystemsPrismatik Dentalcraft, Inc. Nov 14, 2023
K232461 — Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low DermatitisKossan International Sdn Bhd Nov 14, 2023
K232656 — BLU TOTALE (Model: ENEOB852)Premier North America, Inc. Nov 14, 2023
K231783 — VitroPROCIVCO Medical Instruments Co., Inc. Nov 14, 2023
K231521 — Broncho Videoscope SystemScivita Medical Technology Co., Ltd. Nov 14, 2023
K232050 — saremco print BRIDGETECSaremco Dental AG Nov 14, 2023
K232845 — IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd. Nov 14, 2023
K230878 — QScout Lab; QScout RLDAd Astra Diagnostics, Inc. Nov 14, 2023
K231554 — UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd. Nov 14, 2023
K233468 — Iconix AnchorRiverpoint Medical Nov 14, 2023
K232488 — Accu-Chek Safe-T-Pro Plus Lancing DeviceRoche Diabetes Care, Inc. Nov 13, 2023
K232241 — Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)Betters(Suzhou) Medical Co., Ltd. Nov 13, 2023
K230831 — INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC Nov 13, 2023
K232240 — Microwave Ablation System (BD-GT)Betters(Suzhou) Medical Co., Ltd. Nov 13, 2023
K232257 — Clarius Bladder AIClarius Mobile Health Corp. Nov 13, 2023
K232509 — Accu-Chek Safe-T-Pro Uno Lancing DeviceRoche Diabetes Care, Inc. Nov 13, 2023
K231937 — Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. Nov 13, 2023
K231118 — Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd. Nov 13, 2023
K232083 — BriefCase-QuantificationAidoc Medical , Ltd. Nov 13, 2023
K230849 — ELLAVI UBTSinapi Biomedical (Pty) , Ltd. Nov 13, 2023
K231564 — Skin and Wound CleanserWinner Medical Co., Ltd. Nov 10, 2023
K231920 — Longeviti ClearFit OTS Cranial ImplantLongeviti Neuro Solutions, LLC Nov 9, 2023
K233408 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV Nov 9, 2023
K230969 — Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co., Ltd. Nov 9, 2023
K231366 — Neuronaute PlusBioserenity Sas Nov 9, 2023
K233596 — VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG Nov 9, 2023
K232442 — Disposable Endoscope Injection NeedlesZhejiang Soudon Medical Technology Co., Ltd. Nov 9, 2023
K222780 — LILY Extension Tube and Needleless ConnectorLily Medical Corporation Nov 9, 2023
K231508 — Power Wheelchair, W5521Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Nov 9, 2023
K231617 — MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Medical Solutions USA, Inc. Nov 9, 2023
K233366 — SYMPHONY OCT SystemMedos International SARL Nov 9, 2023
K231277 — TissueStatDurastat, LLC Nov 9, 2023
K223754 — BraveCXBering, Ltd. Nov 9, 2023
K230828 — Flowflex COVID-19 Antigen Home TestACON Laboratories, Inc. Nov 9, 2023
K223682 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V. Nov 9, 2023
K231911 — Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A. Nov 9, 2023
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