510(k) Clearances — Page 32

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 32 of 3,525)
ClearancesDetails
K254004 — VRNTCognifisense, Inc. Apr 10, 2026
K252378 — BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson And Company Apr 10, 2026
K260244 — Auryon Atherectomy SystemEximo Medical Apr 10, 2026
K253657 — Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter ReloadsCovidien (Part Of Medtronic) Apr 10, 2026
K260082 — TRIOS Dx (R1)3Shape TRIOS A/S Apr 10, 2026
K252241 — Pressio 3 Multi-parameter Neuromonitoring SystemSophysa Apr 10, 2026
K253926 — DiacoreShenB Co., Ltd. Apr 10, 2026
K252485 — ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media Limited Apr 10, 2026
K253361 — Teleport Glide MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd. Apr 10, 2026
K253930 — Overjet Iris Intelligent Imaging SystemOverjet, Inc. Apr 10, 2026
K252708 — Relu CloudRelu BV Apr 10, 2026
K252506 — BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson And Company Apr 10, 2026
K252699 — CoAptix S SystemUniversity Of Utah, Department Of Orthopaedics Apr 10, 2026
K252207 — ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps Apr 10, 2026
K253689 — syngo Dynamics (VA41F)Siemens Healthcare GmbH Apr 10, 2026
K253917 — ARION ARC SystemPlasma Surgical, Inc. Apr 10, 2026
K252548 — AI-Rad Companion Organs RTSiemens Healthcare GmbH Apr 10, 2026
K253777 — Ascblue (8010)Ascblue Corporation Apr 10, 2026
K253446 — AeroDR TX c02Dk Medical Systems Co., Ltd. Apr 10, 2026
K260430 — Porcelain Etch GelBelport Company, Inc., Gingi-Pak Apr 10, 2026
K252250 — Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)Shanghai Draeger Medical Instrument Co., Ltd. Apr 10, 2026
K252929 — Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)Anhui Happiness Workshop Instruments Co., Ltd. Apr 9, 2026
K260462 — RCT800Ray Co., Ltd. Apr 9, 2026
K254158 — SPINEART Navigation Instrument SystemSpineart SA Apr 9, 2026
K260017 — Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd. Apr 9, 2026
K260245 — SILKBridgeKLISBio S.R.L. Apr 9, 2026
K254021 — Accuro XVRivanna Medical, Inc. Apr 9, 2026
K260555 — LOCATOR® Angled AbutmentZest Anchors, LLC Apr 9, 2026
K252251 — EASYMADE-TICG Bio Co., Ltd. Apr 9, 2026
K253975 — Radical 6F Access CatheterMaduro Medical, Inc. Apr 9, 2026
K252228 — Seaman Pro/SeamanCheckcells, Inc. Apr 9, 2026
K260317 — Artelon Convenience KitsInternational Life Sciences Apr 9, 2026
K260067 — Eternal Art Porcelain PowdersShandong Huge Dental Material Corporation Apr 9, 2026
K252224 — Apex Locator (FindPex)Changzhou Sifary Medical Technology Co., Ltd. Apr 8, 2026
K260089 — TL-10 Laparoscopic Scope CleanerScopix , Ltd. Apr 8, 2026
K251889 — myAirResmed Corp Apr 8, 2026
K260816 — OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston Scientific Apr 8, 2026
K252270 — HemoclipHangzhou AGS MedTech Co., Ltd. Apr 8, 2026
K253268 — Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes CapCMT Health PTE., Ltd. Apr 8, 2026
K251666 — SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS Corporation Apr 8, 2026
K260477 — CATAMARAN™ SI Joint Fusion SystemTenon Medical Apr 8, 2026
K253534 — Pivot Insulin Delivery SystemModular Medical Apr 8, 2026
K254258 — Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)Shenzhen Root Innovation Technology Co., Ltd. Apr 8, 2026
K260033 — Wearable Breast Pump (Model S21A)Shenzhen TPH Technology Co., Ltd. Apr 8, 2026
K260420 — LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd. Apr 8, 2026
K260197 — Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)Suzhou Shenyun Medical Equipment Co., Ltd. Apr 8, 2026
K260766 — Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation Apr 8, 2026
K252979 — Voyager DSLT (430840610)Belkin Vision, Ltd. Apr 7, 2026
K260860 — Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc. Apr 7, 2026
K252861 — Warming SystemHangzhou Tappa Medical Technology Co., Ltd. Apr 7, 2026
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