510(k) Clearances — Page 138

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 138 of 3,525)
ClearancesDetails
K241080 — Kerecis Parvus (50207)Kerecis Limited Aug 21, 2024
K240077 — Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)Covidien Aug 20, 2024
K231932 — TDS (TECHWIN DENTAL SYSTEM)Techwin Co., Ltd. Aug 20, 2024
K242189 — CELERITY HP Indicator Tape (PCC077)Steris Aug 20, 2024
K241738 — PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd. Aug 20, 2024
K240200 — HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept Biorobotics Aug 20, 2024
K241848 — MedtFine Safety LancetNingbo Caremed Medical Products Co., Ltd. Aug 20, 2024
K241496 — Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Aug 20, 2024
K242134 — ClearCap Distal AttachmentFinemedix Co., Ltd. Aug 20, 2024
K241102 — Luna 4 plusForeo, Inc. Aug 20, 2024
K234114 — CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)Okapi Medical, LLC Dba Resivant Medical Aug 20, 2024
K241458 — Borvo EVAC System (Ergo); Borvo EVAC System (Classic)Borvo Medical, Inc. Aug 20, 2024
K241282 — RibFix Titan™ Fixation SystemRiverpoint Medical Aug 19, 2024
K241275 — Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA Aug 19, 2024
K241023 — Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc. Aug 19, 2024
K241870 — OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc. Aug 19, 2024
K240235 — OmniTrans Transport SystemShenzhen Dakewe Bio-Engineering Co., Ltd. Aug 19, 2024
K242432 — MT-BoneMectron S.P.A. Aug 19, 2024
K241440 — HealthCCSngNano-X AI , Ltd. Aug 19, 2024
K241504 — iFuse TORQ TNT™ Implant SystemSI-BONE, Inc. Aug 19, 2024
K240234 — BTL-899MSBTL Industries, Inc. Aug 17, 2024
K240307 — VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)Shenzhen Vitavitro Biotech Co., Ltd. Aug 16, 2024
K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. Aug 16, 2024
K233755 — HeartKey® RhythmB-Secur Limited Aug 16, 2024
K242108 — Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 AdvanceAmbu A/S Aug 16, 2024
K231979 — Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd. Aug 16, 2024
K222126 — VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd. Aug 16, 2024
K240133 — Xenograft Bovine Bone ParticulateCollagen Solutions, LLC Aug 16, 2024
K241236 — XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. Aug 16, 2024
DEN230090 — First To Know Syphilis TestNowdiagnostics Aug 16, 2024
K242239 — HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))Gentuity, LLC Aug 16, 2024
K240573 — iTero Lumina™ ProAlign Technology , Ltd. Aug 16, 2024
K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)MacroLux Medical Technology Co., Ltd. Aug 16, 2024
K242127 — ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)Instrumentation Laboratory (IL) Co. Aug 16, 2024
K240740 — qCT LN QuantQure.Ai Technologies Aug 16, 2024
K233896 — JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plusJdentalcare Srl Aug 16, 2024
K223700 — BOSS™Intelon Optics, Inc. Aug 16, 2024
K240081 — Human LubricantJiangxi Wulinxiang Biological Technology Co., Ltd. Aug 16, 2024
K233499 — Sapphire NC ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. Aug 16, 2024
K233700 — Avicenna RoboflexElmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi Aug 16, 2024
K240961 — Disposable Pen Injector AssemblyWuxi Nest Biotechnology Co., Ltd. Aug 15, 2024
K241596 — uMI PanvivoShanghai United Imaging Healthcare Co., Ltd. Aug 15, 2024
K233505 — Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. Aug 15, 2024
K241211 — CoLumboSmart Soft Healthcare Aug 15, 2024
K240837 — TOV Dental Implant SystemRdj Tov Implant, Ltd. Aug 15, 2024
K241401 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice ControlStryker Endoscopy Aug 15, 2024
K241750 — Medifun Safety Lancet ( MSL1 series)Medifun Corporation Aug 15, 2024
K241522 — NPseal (20 and 25)Guard Medical, Inc. Aug 15, 2024
K233965 — UltraDrape UGPIV Barrier and Securement (34-15)Parker Laboratories, Inc. Aug 15, 2024
K241754 — NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft PlateZimmer Switzerland Manufacturing GmbH Aug 15, 2024
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