510(k) Clearances in 2023 — Page 9

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 9 of 67)
510(k) clearancesDetails
K232388 — High Pressure TubingNingbo Dizegens Medical Science Co.,Ltd Nov 21, 2023
K232576 — Medical Nitrile Examination GlovesJiangsu Complete Sincerity Medical New Materials Co., Ltd. Nov 21, 2023
K232549 — NemoCastSoftware Nemotec S.L. Nov 21, 2023
K232546 — Meta G UCLA AbutmentCowellmedi Co., Ltd. Nov 21, 2023
K233084 — Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion systemGbs Commonwealth Co., Ltd. Nov 21, 2023
K233245 — MagnetOs Flex MatrixKuros Biosciences B.V Nov 21, 2023
K230834 — CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd. Nov 21, 2023
K230641 — Ultrasonic Scaler TipsGuilin Refine Medical Instrument Co., Ltd. Nov 21, 2023
K233010 — Beagank 4T PlusBelega, Inc. Nov 21, 2023
K233053 — DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral SensorDental Imaging Technologies Corporation Nov 21, 2023
K223615 — Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC Nov 21, 2023
K231443 — Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda Nov 21, 2023
K230773 — Endoscopy Irrigation TubingZhejiang Chuangxiang Medical Technology Co., Ltd. Nov 21, 2023
K230287 — SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd. Nov 21, 2023
K232575 — Hair Removal Device, Model(s): R2815-G Pro, R2815-GShenzhen Jianchao Intelligent Technology Co., Ltd. Nov 20, 2023
K232545 — The SensiTox B. anthracis Toxin TestFirst Light Diagnostics, Inc. Nov 20, 2023
K231692 — Ziehm Vision RFDZiehm Imaging GmbH Nov 20, 2023
K231941 — ARIETTA x10FUJIFILM Healthcare Americas Corporation Nov 20, 2023
K230627 — Zilia Ocular FC (ZIL-10002)Zilia, Inc. Nov 20, 2023
K230700 — RIWOtrack Navigation SystemFiagon GmbH Nov 20, 2023
K233346 — Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010);Hg Innovations, Ltd. Nov 20, 2023
K233351 — Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar ForceHg Innovations, Ltd. Nov 20, 2023
K231498 — TraumaCad NeoBrainlab , Ltd. Nov 20, 2023
K232555 — HarmonyTopcon Healthcare Solutions Nov 20, 2023
K232512 — Masimo W1Masimo Corporation Nov 17, 2023
K230954 — Samfilcon B Custom Contact LensBausch + Lomb, Incorporated Nov 17, 2023
K232501 — AI Platform (AIP001)Exo, Inc. Nov 17, 2023
K232925 — Gastric Alimetry SystemAlimetry , Ltd. Nov 17, 2023
K231600 — SENDERO MicrocatheterOkami Medical, Inc. Nov 17, 2023
K232028 — Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)Iq Endoscopes Limited Nov 17, 2023
K231559 — Multi-Unit DAS SystemTalladium España, SL Nov 17, 2023
K230190 — Polyver Silver Alginate Dressing (Prescription and OTC)Roosin Medical Co., Ltd. Nov 17, 2023
K231020 — Alinity c Tricyclic Antidepressants Reagent KitMicrogenics Corporation Nov 17, 2023
K232974 — EKGenius Smart SystemEkgenius, LLC Nov 17, 2023
K232538 — DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYLWrp Asia Pacific Sdn. Bhd. Nov 17, 2023
K230612 — Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC Nov 17, 2023
K230589 — Celox Rapid X-Ray GauzeMedtrade Products , Ltd. Nov 17, 2023
K231652 — D100 KIDS; D101 KIDSSorin Group Italia S.R.L. Nov 16, 2023
K231445 — LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG Nov 16, 2023
K232921 — DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal ToricAlcon Laboratories, Inc. Nov 16, 2023
K232139 — Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact LensInnova Vision, Inc. Nov 16, 2023
K230451 — Aptima® Chlamydia trachomatis AssayHologic, Inc. Nov 16, 2023
K233302 — OSSIOfiber® Compression StapleOSSIO , Ltd. Nov 16, 2023
K231694 — MASADA Modular Spinal Fixation SystemAstura Medical Nov 16, 2023
K232521 — ExactechGPS® Total Ankle ApplicationBlue Ortho Nov 16, 2023
K231738 — NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc. Nov 16, 2023
K233443 — Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) Nov 16, 2023
K233200 — XPLUS 35 Series (XPLUS 35, XPLUS 35FD)GEMSS HEALTHCARE CO., LTD. Nov 16, 2023
K232392 — CT Lung Ventilation Analysis Software (CT:V)4Dmedical Limited Nov 16, 2023
K232945 — Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (Dba MedComp) Nov 16, 2023
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