510(k) Clearances in 2023 — Page 2

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 2 of 67)
510(k) clearancesDetails
K233112 — HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Dec 21, 2023
K231307 — Elos Accurate Customized AbutmentElos Medtech Pinol A/S Dec 21, 2023
K233276 — Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. Dec 21, 2023
K223359 — LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. Dec 21, 2023
K233465 — RadiForce MX317WEizo Corporation Dec 21, 2023
K232329 — Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning AdapterMedivators (A Subsidiary Of Steris Corporation) Dec 21, 2023
K232784 — RELiZORB®Alcresta Therapeutics, Inc. Dec 21, 2023
K233498 — Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics Dec 21, 2023
K233396 — Cannulated Screw SystemSmith & Nephew, Inc. Dec 21, 2023
K232320 — iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. Dec 21, 2023
K223729 — FLOWpressoMedella Health Limited Dec 21, 2023
K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerSysmex America, Inc. Dec 21, 2023
K232944 — CALLISTO eyeCarl Zeiss Meditec, AG Dec 21, 2023
K231531 — Pediarity™Hinlab, Inc. Dec 21, 2023
K231027 — KaiBiLi Extended ViralTransHangzhou Genesis Biodetection & Biocontrol Co., Ltd. Dec 21, 2023
K233018 — PICOSECOND Nd:YAG Laser SystemIds, Ltd. Dec 21, 2023
K221753 — Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd. Dec 21, 2023
K232579 — Twoplus ApplicatorHannah Life Technologies Pte , Ltd. Dec 21, 2023
K231889 — Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)Ultrasound Biotechnology (Shanghai) Co., Ltd. Dec 21, 2023
K233741 — Hoffmann LRF SystemStryker GmbH Dec 21, 2023
K232888 — Disposable Laryngeal ElectrodesSuzhou Haishen Medical Device Associates Co., Ltd. Dec 21, 2023
K232744 — syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH Dec 21, 2023
K233154 — SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC Dec 21, 2023
K231099 — SMR Hybrid Glenoid SystemLima Corporate S.P.A. Dec 21, 2023
K233813 — Bearing nsPVA Express™Merit Medical Systems, Inc. Dec 21, 2023
K233016 — Dental Glass CeramicsShenzhen Yurucheng Dental Materials Co., Ltd. Dec 21, 2023
K232870 — TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)Varian Medical Systems, Inc. Dec 21, 2023
K233848 — Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc. Dec 21, 2023
K231660 — Digital image scanner of dentalJiangsu Dynamic Medical Technology Co., Ltd. Dec 20, 2023
K232992 — 10THERMATentech, Inc. Dec 20, 2023
K231402 — HP PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. Dec 20, 2023
K231968 — Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc. Dec 20, 2023
K232048 — Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu Medical Dec 20, 2023
K233130 — Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. Dec 20, 2023
K233839 — Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion systemGbs Commonwealth Co., Ltd. Dec 20, 2023
K230850 — United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc. Dec 20, 2023
K233782 — SmoothSkin Pure Adapt (SSG3)Cyden Limited Dec 20, 2023
K233492 — EMS Neck MassagerXiamen Comfier Technology Co., Ltd. Dec 20, 2023
K230736 — MagnetOs PuttyKuros Biosciences B.V Dec 20, 2023
K230955 — syngo Application SoftwareSiemens Medical Solutions USA, Inc. Dec 20, 2023
K223585 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily WearYung Sheng Optical Co., Ltd. Dec 20, 2023
K231354 — Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd Dec 20, 2023
K233176 — uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd. Dec 20, 2023
K232017 — ARK Methotrexate II AssayArk Diagnostics, Inc. Dec 20, 2023
K233017 — TM Plating SystemTyber Medical, LLC Dec 20, 2023
K231227 — SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathBaylis Medical Company, Inc. Dec 20, 2023
K231411 — INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd. Dec 20, 2023
K232444 — Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd. Dec 20, 2023
K231780 — Perifit Care+X6 Innovations Dec 20, 2023
K230855 — BD Vacutainer® Serum Separator (SST™) Blood Collection TubesBecton, Dickinson And Company Dec 20, 2023
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