510(k) Clearances — Page 128

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 128 of 3,525)
ClearancesDetails
K241337 — Electrically powered wheelchair (HP202)Kunshan Hi-Fortune Health Products Co., Ltd. Oct 17, 2024
K211943 — Microlyte Ag/LidocaineImbed Biosciences Oct 17, 2024
K240160 — EGPS Navigated InstrumentsAstura Medical Oct 17, 2024
K242197 — IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)Shenzhen Huaruibo Electric Appliances Co., Ltd. Oct 17, 2024
K241242 — SIGNA MAGNUSGe Medical Systems, LLC Oct 17, 2024
K242839 — Safe Secure Sterilization Pouches and RollsShenzhen Safesecure Medical Infection Control Tech Co. , Ltd. Oct 16, 2024
K242784 — Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC Oct 16, 2024
K241481 — xvision Spine SystemAugmedics, Ltd. Oct 16, 2024
K241221 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. Oct 16, 2024
K240468 — Alkaline PhosphataseAbbott Laboratories Diagnostics Division Oct 16, 2024
K242794 — ONCOZENE MicrospheresVarian Medical Systems, Inc. Oct 16, 2024
K241272 — Stryker Steri-Shield 8 Surgical Hoods and TogasStryker Instruments Oct 16, 2024
K241632 — Electrically powered wheelchairKunshan Hi-Fortune Health Products Co., Ltd. Oct 16, 2024
K242556 — JLK-CTPJLK, Inc. Oct 16, 2024
K240849 — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2Ambu A/S Oct 16, 2024
K241613 — Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)Shenzhen Hbcare Technology Co.,Ltd Oct 16, 2024
K240596 — Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences Oct 16, 2024
K240364 — RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd. Oct 16, 2024
K241244 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterCerenovus, Inc. Oct 16, 2024
DEN230087 — AMStent® Tracheobronchial Covered Stent SystemPeytant Solutions, Inc. Oct 16, 2024
K240114 — UltraEzAir® (UEA1A)Dualams, Inc., Dba Airkor Oct 16, 2024
K231997 — SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc. Oct 15, 2024
K240192 — Single-use Extraction BasketsScivita Medical Technology Co., Ltd. Oct 15, 2024
K241894 — Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathInari Medical, Inc. Oct 15, 2024
K240385 — VINTMediimg Corporation Oct 15, 2024
K242097 — DenMat Bulk Fill CompositeDen-Mat Holdings, LLC Oct 15, 2024
K242781 — cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc. Oct 15, 2024
K241673 — Denture Base Resin (PN-Denture (Red, White))Shenzhen Piocreat 3D Technology Co., Ltd. Oct 15, 2024
K242795 — Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg. (A Getinge Group Company) Oct 15, 2024
K242536 — TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group Oct 15, 2024
K242812 — NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)Nb Medical Company Limited Oct 12, 2024
K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)STERIS Corporation Oct 11, 2024
K242095 — Access Toxo IgM IIBeckman Coulter, Inc. Oct 11, 2024
K232565 — UriSponge™Copan Italia Spa Oct 11, 2024
K242779 — Hood (DH-083ST)Fujifilm Corporation Oct 11, 2024
K242387 — Mobility Scooter (N3473)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Oct 11, 2024
K242833 — Legend® Acetabular ShellOrtho Development Corp. Oct 11, 2024
K234110 — Belun Ring BLR-200 (BLR-200)Belun Technology Company Limited Oct 11, 2024
K241857 — LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd Oct 11, 2024
K242778 — X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc. Oct 11, 2024
K241153 — Progressive Orthodontics AppProgressive Aligners, Inc. Oct 11, 2024
K241163 — SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH Oct 11, 2024
K240826 — Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology CatheterSterilmed, Inc. Oct 11, 2024
K240501 — Spark™ Clear Aligner SystemOrmco Corporation Oct 11, 2024
K240143 — JDZygoma dental implantsJdentalcare Srl Oct 11, 2024
K233265 — Monotime and Optime RPeters Surgical Oct 11, 2024
K232779 — QUEX ED; QUEX SQx World, Ltd. Oct 11, 2024
K241971 — HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Oct 11, 2024
K241569 — syngo Application SoftwareSiemens Medical Solutions USA, Inc. Oct 11, 2024
K240797 — PPH Saliva Collection KitPermantis Public Health Oct 11, 2024
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