510(k) Clearances — Page 176

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 176 of 3,525)
ClearancesDetails
K231068 — autoSCOREHolberg Eeg AS Jan 7, 2024
K231608 — Teleport XT MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd. Jan 7, 2024
K232721 — Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. Jan 7, 2024
K231163 — HS Fiber SuturesRiverpoint Medical Jan 5, 2024
K233229 — NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica Corporation Jan 5, 2024
K233679 — IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)Shenzhen Ulike Smart Electronics Co., Ltd. Jan 5, 2024
K231917 — VEA AlignEos Imaging Jan 5, 2024
K231273 — ArcherQA (V1.0)Wisdom Technologies., Inc. Jan 5, 2024
K233316 — DESS Dental Smart SolutionsTerrats Medical SL Jan 5, 2024
K231263 — Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTPrevest Denpro Limited Jan 5, 2024
K221766 — SolonLmg Lasers Comercio, Importacao E Exportacao Ltda Jan 5, 2024
K232519 — ENDOCOLLECT Specimen Retrieval BagXimedica Jan 5, 2024
K233556 — LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd. Jan 4, 2024
K231072 — Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr Jan 4, 2024
K230996 — Pursuant Health Kiosk (G1.D5)Pursuant Health Jan 4, 2024
K232808 — Butterfly iQ3 Ultrasound SystemButterfly Network, Inc. Jan 4, 2024
K230507 — Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal Jan 4, 2024
K232330 — Lancing SystemNingbo Medsun Medical Co., Ltd. Jan 4, 2024
K221110 — LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover DressingHuizhou Foryou Medical Devices Co., Ltd. Jan 4, 2024
K233671 — Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 AdvanceAmbu A/S Jan 4, 2024
K232136 — syngo.CT ApplicationsSiemens Medical Solutions USA, Inc. Jan 4, 2024
K230277 — Pulse Oximeter(Model OHT60,OXH78)Cofoe Medical Technology Co., Ltd. Jan 4, 2024
K231033 — CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited Jan 4, 2024
K231058 — Hudson RCI® AddiPak® Unit Dose VialMedline Industries, LP Jan 4, 2024
K223228 — DayspringKoya Medical, Inc. Jan 4, 2024
K223397 — HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact LensHoya Lamphun , Ltd. Jan 3, 2024
K233395 — Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)Alliage S/A Industrias Médico Odontológica Jan 3, 2024
K231707 — ResQ Administration SetQ For Plastic Industries Jan 3, 2024
K231779 — REMI AI Discrete Detection ModuleEpitel, Inc. Jan 3, 2024
K231256 — Carecube Negative Pressure Isolation ChamberCarecubes, Inc. Jan 3, 2024
K232589 — Horos MD™Icat Solutions, Ltd. Jan 3, 2024
K233550 — MOSAIC 3D (Surgical Laser)Lutronic Aesthetic Jan 2, 2024
K223714 — UniFit Dental Implant SystemAdin Dental Implant Systems , Ltd. Dec 29, 2023
K230986 — Bladder ScannerAvantsonic Technology Co., Ltd. Dec 29, 2023
K233790 — ACL TOP 970 CLInstrumentation Laboratory Dec 29, 2023
K232688 — NQ TMS for MDD (NQv1-MU-01)Neuroqore, Inc. Dec 29, 2023
K230438 — URIS Smart Path Implant System & ProstheticTruabutment, Inc. Dec 29, 2023
K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc. Dec 29, 2023
K233856 — Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 MultifocalAlcon Laboratories, Inc. Dec 29, 2023
K230997 — EvoWalk 1.0 SystemEvolution Devices, Inc. Dec 28, 2023
K230985 — Planmeca VisoPlanmeca Oy Dec 28, 2023
K233405 — Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test ClaimEco Medi Glove Sdn. Bhd. Dec 28, 2023
K230006 — AnkyrasMentice Spain S.L. Dec 28, 2023
K230891 — SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantHealthium Medtech Limited Dec 28, 2023
K231055 — x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)De Götzen S.R.L. Dec 28, 2023
K233858 — TriSalus TriGuideTM Guiding CatheterTrisalus Life Sciences Dec 27, 2023
K232518 — EndoSound Vision System; EVSEndosound, Inc. Dec 27, 2023
K231914 — Nurochek-II SystemHeadsafe Mfg Pty, Ltd. Dec 27, 2023
K232756 — ColibríCopan Wasp Srl Dec 27, 2023
K231084 — TearCare MGX SystemSight Sciences, Inc. Dec 27, 2023
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