510(k) Clearances — Page 117

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 117 of 3,525)
ClearancesDetails
K242297 — Reform Pedicle Screw SystemPrecision Spine, Inc. Dec 17, 2024
K241616 — ALLONUS Tech ProstheticsAllonus Tech Co., Ltd. Dec 17, 2024
K242783 — Roche Digital Pathology DxVentana Medical Systems, Inc. Dec 17, 2024
K242869 — prodisc® L InstrumentsCentinel Spine, LLC Dec 17, 2024
K243664 — Sentinel CameraAi Optics Dec 17, 2024
K242015 — TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation Dec 16, 2024
K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. Dec 16, 2024
K232839 — Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily WearYung Sheng Optical Co., Ltd. Dec 16, 2024
K240809 — LUOFUCON® Silver Collagen DressingHuizhou Foryou Medical Devices Co., Ltd. Dec 16, 2024
K242307 — ACHIEVE Partial Knee SystemIgnite Orthomotion Dec 16, 2024
K240937 — AIM (N/A)Inventeur, LLC Dec 16, 2024
K243471 — Extraction BasketMicro-Tech (Nanjing) Co., Ltd. Dec 16, 2024
K240793 — MSKaiMskai Dec 16, 2024
K240676 — ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd Dec 16, 2024
K243066 — Dental Implants and AbutmentsDitron Dental, Ltd. Dec 16, 2024
K243641 — da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. Dec 16, 2024
K240873 — TEMBO Embolic SystemInstylla, Inc. Dec 16, 2024
K242124 — Sim&SizeSim&Cure Dec 14, 2024
K233001 — Bioscope Neuromonitor DeviceBiosys Biyomedikal Muhendislik San. VE Tic. A.S. Dec 13, 2024
K242668 — Gastro Concepts Air AssistGastro Concepts, LLC Dec 13, 2024
K243560 — Remex Spine Surgery Navigation InstrumentRemex Medical Corp. Dec 13, 2024
K243281 — LOCK-IN Spinal Fixation SystemLock-In USA Corp Dec 13, 2024
K240924 — AnterionHeidelberg Engineering GmbH Dec 13, 2024
K233486 — 731 Series VentilatorZOLL Medical Corporation Dec 13, 2024
K242463 — ARIA Radiation Therapy Management System (18.1)Varian Medical Systems, Inc. Dec 13, 2024
K243493 — Agilis NxT Steerable Introducer Dual-ReachABBOTT MEDICAL Dec 13, 2024
K231424 — HeartBeam AIMIGo(TM) SystemHeartbeam, Inc. Dec 13, 2024
K243307 — LCD Monitor (MDEC-2523)Barco N.V. Dec 13, 2024
K241160 — CAIs Sensor (CAIs-001)Brainu Co., Ltd. Dec 13, 2024
K243635 — aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. Dec 13, 2024
K242532 — BTL-785BNF-EBTL Industries, Inc. Dec 13, 2024
K240998 — ABL90 FLEX PLUS SystemRadiometer Medicals Aps Dec 13, 2024
K240778 — Vivo 1, Vivo 2Breas Medical AB Dec 13, 2024
K242487 — Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc. Dec 13, 2024
K241998 — Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)Shenzhen Ulike Smart Electronics Co., Ltd. Dec 13, 2024
K240779 — Vivo 3Breas Medical AB Dec 13, 2024
K243196 — Uro-G HD Cystoscope (1520)Uroviu Corporation Dec 13, 2024
K242453 — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)Terragene S.A. Dec 12, 2024
K242020 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC Dec 12, 2024
K242934 — Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd. Dec 12, 2024
K241389 — Infrascanner Model 2500 (Model 2500)Infrascan, Inc. Dec 12, 2024
K240735 — visio.lign color, visio.lign shieldBredent GmbH & Co. KG Dec 12, 2024
K243495 — Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated Dec 12, 2024
K243538 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd. Dec 12, 2024
K241271 — Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc. Dec 12, 2024
K233152 — GENIOVA alignersGeniova Technologies Sociedad Limitada Dec 12, 2024
K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)Ge Medical Systems Information Technologies, Inc. Dec 12, 2024
K241253 — Medicon Epiplating SystemCmf Medicon Surgical, Inc. Dec 12, 2024
K242832 — NExT Station; NExT Station AdvancedEb Neuro S.P.A. Dec 12, 2024
K243498 — Alinity c Benzodiazepines Reagent KitMicrogenics Corporation Dec 11, 2024
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