510(k) Clearances — Page 133

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 133 of 3,525)
ClearancesDetails
K241784 — Arrow® Nitinol WireTeleflex Medical Sep 18, 2024
K231893 — LOWTEM Crystal 120Lowtem Co., Ltd. Sep 18, 2024
K234153 — EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)Edgelife Technologies, LLC Sep 18, 2024
K234142 — TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd. Sep 18, 2024
K233064 — Copra SupremeWhitepeaks Dental Solutions GmbH Sep 18, 2024
K231383 — Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)Terragene S.A. Sep 18, 2024
K241123 — Perpak™ Sterilization Tyvek PouchKm Corp. Sep 18, 2024
K241769 — Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC Sep 18, 2024
K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd. Sep 18, 2024
K233721 — KLS Martin Drill-Free MMF ScrewKLS-Martin L.P. Sep 17, 2024
K240373 — Air compression Leg Massager (MM0520, MM0521, MM0522)Zhangzhou Easepal Medical Science And Technology Co., Ltd. Sep 17, 2024
K240274 — PADLOCK CLIP EFTR Kit (00713229)STERIS Corporation Sep 17, 2024
K240689 — Robin's EggTelebrands Corporation Sep 17, 2024
K240250 — 3D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. Sep 17, 2024
K240293 — STSTechbopulm, Ltd. Sep 17, 2024
K241942 — TriMed Bridge PlatesTriMed, Inc. Sep 17, 2024
K234132 — Medline Reusable Sterilization WrappersMedline Industries, LP Sep 17, 2024
K242186 — Neo Sculptor (OF-NEO001)Ofan Intelligent Technology (Guangzhou) Co. , Ltd. Sep 17, 2024
K241230 — Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008Togo Medikit Co., Ltd. Sep 17, 2024
K240660 — Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-activeKulzer, LLC Sep 17, 2024
K241771 — Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda. Sep 16, 2024
K241379 — Powered Wheelchair (NXN20-205, NXN20-205M)Zhejiang Nysin Medical Co., Ltd. Sep 16, 2024
K241762 — OneMarkView Point Medical Sep 16, 2024
K240638 — Power Wheelchair (YH-E7007)Ningbo Youhuan Automation Technology Co., Ltd. Sep 16, 2024
K232938 — Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd. Sep 16, 2024
K241335 — Eversense 365 Continuous Glucose Monitoring (CGM) SystemSenseonics, Incorporated Sep 16, 2024
K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL Sep 16, 2024
K234089 — DNA ApplianceVivos Therapeutics Sep 16, 2024
K234050 — HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization WrapO&M Halyard, Inc. Sep 16, 2024
K241201 — TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Sep 16, 2024
K241156 — Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401Surgical Instrument Service And Savings, Inc. Sep 14, 2024
K240188 — Vitruvian LiposaberBlack & Black Surgical, Inc. Sep 13, 2024
K240977 — DenQ Sub SLA Implant SystemDenq Sep 13, 2024
K241722 — Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S Sep 13, 2024
K240176 — V-VITFREEZE and V-VITWARMVitromed GmbH Sep 13, 2024
K233399 — Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. Sep 13, 2024
K240544 — EpitomeeEpitomee Medical , Ltd. Sep 13, 2024
K242441 — Revian Lyte (10011)Revian, Inc. Sep 13, 2024
K241875 — TheRay Collared and Collarless Femoral StemNextstep Arthropedix Sep 13, 2024
K240929 — Sleep Apnea Notification Feature (SANF)Apple, Inc. Sep 13, 2024
K240087 — RT Carbon ECG LeadsIvy Biomedical Systems, Inc. Sep 13, 2024
K234063 — T2Candida 1.1 PanelT2Biosystems, Inc. Sep 13, 2024
K240232 — EK D3.3 and Ultra Wide ImplantsHiossen, Inc. Sep 13, 2024
K241695 — Extremity All Suture SystemField Orthopaedics Sep 12, 2024
K241280 — Constellation (CON-001)Q Bio, Inc. Sep 12, 2024
K241249 — Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)Palodex Group OY Sep 12, 2024
K240803 — Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC Sep 12, 2024
K241524 — Elucid PlaqueIQElucid Bioimaging, Inc. Sep 12, 2024
K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.L Sep 12, 2024
K220999 — Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd. Sep 12, 2024
← Previous Page 133 of 3525 Next →