| K250218 — Xpert® FII & FV | Cepheid Feb 21, 2025 |
| K250027 — Powered Mobility Scooter | Intradin (Shanghai) Machinery Co., Ltd. Feb 21, 2025 |
| K243614 — Sonio Suspect | Sonio Feb 21, 2025 |
| K243951 — TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. Feb 21, 2025 |
| K241186 — Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. Feb 21, 2025 |
| K243330 — LYMA Laser PRO | Lyma Life , Ltd. Feb 21, 2025 |
| K243258 — Paradigm System | Proprio, Inc. Feb 21, 2025 |
| K243115 — Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) | Shenzhen Urion Technology Co., Ltd. Feb 21, 2025 |
| K241555 — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | Rti Surgical, Inc. Feb 21, 2025 |
| K243940 — VITA YZ Multi Translucent | Vita Zahnfabrik H.Rauter GmbH & Co. Feb 21, 2025 |
| K243916 — Primus Spinal Fixation System | Spinal Elements, Inc. Feb 21, 2025 |
| K241563 — Extremity Medical External Fixation System | Extremity Medical, LLC Feb 21, 2025 |
| K242838 — QuickRad | Aikenist Technologies Pvt, Ltd. Feb 21, 2025 |
| K242898 — Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. Feb 21, 2025 |
| K242850 — Wearable breast pump (model W8) | Shenzhen TPH Technology Co., Ltd. Feb 21, 2025 |
| K241983 — Fassier-Duval Telescoping IM System | Orthopediatrics Canada Ulc Dba Pega Medical Feb 21, 2025 |
| K243640 — Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) | Church & Dwight Co., Inc. Feb 21, 2025 |
| K243431 — Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. Feb 21, 2025 |
| K243088 — Green X 12 SE (PHT-40CHS) | VATECH Co., Ltd. Feb 21, 2025 |
| K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | Guangzhou Decheng Biotechnology Co., Ltd. Feb 20, 2025 |
| 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. Feb 20, 2025 |
| 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. Feb 20, 2025 |
| K242821 — EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | Ever Fortune.Ai, Co., Ltd. Feb 20, 2025 |
| K242681 — NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) | Nurodata, Inc. Feb 20, 2025 |
| K242447 — Falcon HST | Compumedics Limited Feb 20, 2025 |
| K241470 — CORE Shoulder System | LinkBio Corp. Feb 20, 2025 |
| K250172 — Green Card Bowie-Dick Test (BD115) | Steritec Products, Inc. (A Getinge Company) Feb 20, 2025 |
| K234004 — Medical diode laser systems (CHARISMA, REGAL) | Reveal Lasers , Ltd. Feb 20, 2025 |
| K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation Feb 20, 2025 |
| K243283 — Alinity h-series System | Abbott Laboratories Feb 20, 2025 |
| K250487 — SparkTM Clear Aligner System | Ormco Corporation Feb 20, 2025 |
| K241626 — SperSort Sperm Sorting Chip (IPG02) | Ipreg Incorporation Feb 20, 2025 |
| K243312 — CER-S | Cardiocalm Srl Feb 20, 2025 |
| K242240 — CaRi-Plaque | Caristo Diagnostics , Ltd. Feb 20, 2025 |
| K243344 — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Arthrex, Inc. Feb 20, 2025 |
| K243241 — Phasix ST Umbilical Hernia Patch | Davol, Inc., A Subsidiary Of C.R. Bard, Inc. Feb 19, 2025 |
| K241666 — EVOS Pelvic and Acetabular System | Smith & Nephew Feb 19, 2025 |
| K244015 — SuperBall-RC | Arcuro Medical , Ltd. Feb 19, 2025 |
| 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. Feb 19, 2025 |
| K250473 — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | Dci International, LLC Feb 19, 2025 |
| K242526 — Visby Medical Respiratory Health Test | Visby Medical, Inc. Feb 19, 2025 |
| K243761 — A.L.P.S. Small Fragment Plating System | Biomet Orthopedics Feb 19, 2025 |
| K243588 — Single Use CO2 Laser Fiber (HAF005001) | Quanta System Spa Feb 19, 2025 |
| K243478 — Straumann InLab Validated Workflow | Institut Straumann AG Feb 19, 2025 |
| K242023 — Microdent Sterilization Cassette | Implant Microdent System S.L.U. Feb 19, 2025 |
| K242455 — AViTA Pulse Oximeter (SP62B) | Avita Corporation Feb 19, 2025 |
| K241578 — Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | Shenzhen Bsx Technology Electronics Co., Ltd. Feb 19, 2025 |
| K243591 — OPTOVISION Endoscopic Light Source Unit | Optosurgical, LLC Feb 19, 2025 |
| K242411 — Brainomix 360 e-Lung | Brainomix Limited Feb 19, 2025 |
| K243792 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) | Basic Medical Technology, Inc. Feb 18, 2025 |