510(k) Clearances

174,759 clearances total

K232479 — ART-PlanTherapanacea Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232293 — kallisio stentra™ oral stentKallisio, Inc. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K234043 — 3M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233205 — Distal Access CatheterShanghai Heartcare Medical Technology Co., Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233423 — Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233112 — HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233465 — RadiForce MX317WEizo Corporation Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233018 — PICOSECOND Nd:YAG Laser SystemIds, Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233276 — Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232320 — iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232944 — CALLISTO eyeCarl Zeiss Meditec, AG Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231307 — Elos Accurate Customized AbutmentElos Medtech Pinol A/S Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233498 — Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231027 — KaiBiLi Extended ViralTransHangzhou Genesis Biodetection & Biocontrol Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K221753 — Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223359 — LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232784 — RELiZORB®Alcresta Therapeutics, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231531 — Pediarity™Hinlab, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerSysmex America, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232579 — Twoplus ApplicatorHannah Life Technologies Pte , Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231889 — Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)Ultrasound Biotechnology (Shanghai) Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233741 — Hoffmann LRF SystemStryker GmbH Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232888 — Disposable Laryngeal ElectrodesSuzhou Haishen Medical Device Associates Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232744 — syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223729 — FLOWpressoMedella Health Limited Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233154 — SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231099 — SMR Hybrid Glenoid SystemLima Corporate S.P.A. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233813 — Bearing nsPVA Express™Merit Medical Systems, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233396 — Cannulated Screw SystemSmith & Nephew, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233016 — Dental Glass CeramicsShenzhen Yurucheng Dental Materials Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232870 — TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)Varian Medical Systems, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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) Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233848 — Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233782 — SmoothSkin Pure Adapt (SSG3)Cyden Limited Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230850 — United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232017 — ARK Methotrexate II AssayArk Diagnostics, Inc. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231968 — Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231354 — Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233017 — TM Plating SystemTyber Medical, LLC Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233492 — EMS Neck MassagerXiamen Comfier Technology Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230736 — MagnetOs PuttyKuros Biosciences B.V Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232992 — 10THERMATentech, Inc. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231402 — HP PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233130 — Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233176 — uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230955 — syngo Application SoftwareSiemens Medical Solutions USA, Inc. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231660 — Digital image scanner of dentalJiangsu Dynamic Medical Technology Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232048 — Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu Medical Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231227 — SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathBaylis Medical Company, Inc. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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