510(k) Clearances — Page 177

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 177 of 3,525)
ClearancesDetails
K232937 — BTL-899MBTL Industries, Inc. Dec 26, 2023
K233300 — POWEReam 1/4 DriveStryker Instruments Dec 26, 2023
K233515 — Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)Nuwellis, Inc. Dec 26, 2023
K231130 — TumorSight VizSimBioSys, Inc. Dec 26, 2023
K233659 — Suture WingOsteonic Co., Ltd. Dec 26, 2023
K232479 — ART-PlanTherapanacea Dec 22, 2023
K232293 — kallisio stentra™ oral stentKallisio, Inc. Dec 22, 2023
K231086 — CPM SystemAnalog Devices, Inc. Dec 22, 2023
K233109 — TP Pivot Pro™ Needle GuideCivco Medical Solutions Dec 22, 2023
K233058 — VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd. Dec 22, 2023
K234043 — 3M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products Dec 22, 2023
K232789 — VIO System (V-1000)Enspectra Health, Inc. Dec 22, 2023
K233082 — TopCEM Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd. Dec 22, 2023
K232717 — Apex Locator (AL-Pex), Apex Locator (AL-Pex+)Changzhou Haili Medical Co., Ltd. Dec 22, 2023
K231794 — Elegant™ Advanced CompHortViramal Limited Dec 22, 2023
K233304 — Omnimax S3, Omnimax S4Sharplight Technologies, Ltd. Dec 22, 2023
K233264 — Anthogyr INTEGRAL Guided Surgery CassettesAnthogyr Dec 22, 2023
K230439 — WellCare AnoscopeWell Care (Wuhan) Medical Technology Co., Ltd. Dec 22, 2023
K233205 — Distal Access CatheterShanghai Heartcare Medical Technology Co., Ltd. Dec 22, 2023
K233104 — SofWave SystemSofwave Medical, Ltd. Dec 22, 2023
K231805 — qXR-LNQure.Ai Technologies Dec 22, 2023
K232300 — ElastiMed SACSElastimed , Ltd. Dec 22, 2023
K230267 — NeuMoDx CT/NG Assay 2.0Neumodx Molecular, Inc. Dec 22, 2023
K232338 — Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383Alicn Medical Shenzhen, Inc. Dec 22, 2023
K233742 — CloudTMS Edge for OCDTeleemg, LLC Dec 22, 2023
DEN230020 — BioTraceIO LiteTechsomed Medical Technologies , Ltd. Dec 22, 2023
K233734 — Interson USB Ultrasound SystemInterson Corporation Dec 22, 2023
K232535 — MAGNETOM Sola; MAGNETOM AlteaSiemens Medical Solutions USA, Inc. Dec 22, 2023
K223745 — Novae® Dual Mobility System, Hype® Hip SystemSerf Dec 22, 2023
K233027 — NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. Dec 22, 2023
K232881 — Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle HolderJiangsu Kangbao Medical Equipment Co., Ltd. Dec 22, 2023
K233423 — Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC Dec 21, 2023
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
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