510(k) Clearances — Page 89
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K250027 — Powered Mobility Scooter | Intradin (Shanghai) Machinery Co., Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243330 — LYMA Laser PRO | Lyma Life , Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241555 — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | Rti Surgical, Inc. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241983 — Fassier-Duval Telescoping IM System | Orthopediatrics Canada Ulc Dba Pega Medical Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242898 — Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241563 — Extremity Medical External Fixation System | Extremity Medical, LLC Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241186 — Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243258 — Paradigm System | Proprio, Inc. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243951 — TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242838 — QuickRad | Aikenist Technologies Pvt, Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243278 — Custom Abutments | Institut Straumann AG Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243088 — Green X 12 SE (PHT-40CHS) | VATECH Co., Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250487 — SparkTM Clear Aligner System | Ormco Corporation Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234004 — Medical diode laser systems (CHARISMA, REGAL) | Reveal Lasers , Ltd. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250172 — Green Card Bowie-Dick Test (BD115) | Steritec Products, Inc. (A Getinge Company) Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250214 — Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) | Edan Instruments, Inc. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | Guangzhou Decheng Biotechnology Co., Ltd. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242681 — NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) | Nurodata, Inc. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243283 — Alinity h-series System | Abbott Laboratories Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242821 — EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | Ever Fortune.Ai, Co., Ltd. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243312 — CER-S | Cardiocalm Srl Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243344 — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Arthrex, Inc. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242240 — CaRi-Plaque | Caristo Diagnostics , Ltd. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242447 — Falcon HST | Compumedics Limited Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241626 — SperSort Sperm Sorting Chip (IPG02) | Ipreg Incorporation Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241470 — CORE Shoulder System | LinkBio Corp. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243086 — Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) | Unimed Medical Supplies, Inc. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241666 — EVOS Pelvic and Acetabular System | Smith & Nephew Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242455 — AViTA Pulse Oximeter (SP62B) | Avita Corporation Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250473 — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | Dci International, LLC Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243241 — Phasix ST Umbilical Hernia Patch | Davol, Inc., A Subsidiary of C.R. Bard, Inc. Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242526 — Visby Medical Respiratory Health Test | Visby Medical, Inc. Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243761 — A.L.P.S. Small Fragment Plating System | Biomet Orthopedics Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243588 — Single Use CO2 Laser Fiber (HAF005001) | Quanta System Spa Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241578 — Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | Shenzhen Bsx Technology Electronics Co., Ltd. Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242023 — Microdent Sterilization Cassette | Implant Microdent System S.L.U. Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243478 — Straumann InLab Validated Workflow | Institut Straumann AG Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244015 — SuperBall-RC | Arcuro Medical , Ltd. Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242411 — Brainomix 360 e-Lung | Brainomix Limited Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243591 — OPTOVISION Endoscopic Light Source Unit | Optosurgical, LLC Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243206 — Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) | Sichuan Qianli-Beoka Medical Technology, Inc. Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243915 — FIX-C 3D Ti ACIF System | Jeil Medical Corporation Tue Feb 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243792 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) | Basic Medical Technology, Inc. Tue Feb 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243574 — Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | Microport Orthopedics, Inc. Tue Feb 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom | Okamoto USA, Inc. Tue Feb 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243576 — RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port | Smith & Nephew Medical, Ltd. Tue Feb 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243593 — AXS Lift Intracranial Base Catheter | Stryker Neurovascular Tue Feb 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241737 — Sway System Sports Plus | Sway Medical, Inc. Sat Feb 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243294 — Brainomix 360 e-ASPECTS | Brainomix Limited Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |