| K250172 — Green Card Bowie-Dick Test (BD115) | Steritec Products, Inc. (A Getinge Company) 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 |
| K250487 — SparkTM Clear Aligner System | Ormco Corporation Feb 20, 2025 |
| K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | Guangzhou Decheng Biotechnology Co., Ltd. Feb 20, 2025 |
| K234004 — Medical diode laser systems (CHARISMA, REGAL) | Reveal Lasers , Ltd. Feb 20, 2025 |
| K243312 — CER-S | Cardiocalm Srl Feb 20, 2025 |
| K243344 — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Arthrex, Inc. Feb 20, 2025 |
| K242240 — CaRi-Plaque | Caristo Diagnostics , Ltd. Feb 20, 2025 |
| K242447 — Falcon HST | Compumedics Limited Feb 20, 2025 |
| K241626 — SperSort Sperm Sorting Chip (IPG02) | Ipreg Incorporation Feb 20, 2025 |
| K241470 — CORE Shoulder System | LinkBio Corp. 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 |
| K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation Feb 20, 2025 |
| K241666 — EVOS Pelvic and Acetabular System | Smith & Nephew Feb 19, 2025 |
| K243241 — Phasix ST Umbilical Hernia Patch | Davol, Inc., A Subsidiary Of C.R. Bard, Inc. Feb 19, 2025 |
| K250473 — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | Dci International, LLC Feb 19, 2025 |
| K242455 — AViTA Pulse Oximeter (SP62B) | Avita Corporation 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 |
| K241578 — Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | Shenzhen Bsx Technology Electronics Co., Ltd. Feb 19, 2025 |
| K242023 — Microdent Sterilization Cassette | Implant Microdent System S.L.U. Feb 19, 2025 |
| K243478 — Straumann InLab Validated Workflow | Institut Straumann AG Feb 19, 2025 |
| K244015 — SuperBall-RC | Arcuro Medical , Ltd. Feb 19, 2025 |
| K242411 — Brainomix 360 e-Lung | Brainomix Limited Feb 19, 2025 |
| K243591 — OPTOVISION Endoscopic Light Source Unit | Optosurgical, LLC 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 |
| K243915 — FIX-C 3D Ti ACIF System | Jeil Medical Corporation Feb 18, 2025 |
| K243574 — Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | Microport Orthopedics, Inc. Feb 18, 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 |
| K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom | Okamoto USA, Inc. Feb 18, 2025 |
| 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. Feb 18, 2025 |
| K243593 — AXS Lift Intracranial Base Catheter | Stryker Neurovascular Feb 18, 2025 |
| K241737 — Sway System Sports Plus | Sway Medical, Inc. Feb 15, 2025 |
| K241958 — WARD-CSS (v1.2.x) | Ward 24/7 Aps Feb 14, 2025 |
| K243081 — Green X 21 (PHT-90CHO) | VATECH Co., Ltd. Feb 14, 2025 |
| K241643 — WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | Wontech Co., Ltd. Feb 14, 2025 |
| K243696 — AVIEW CAC | Coreline Soft Co., Ltd. Feb 14, 2025 |
| K243212 — DESS Dental Smart Solutions | Terrats Medical SL Feb 14, 2025 |
| K243294 — Brainomix 360 e-ASPECTS | Brainomix Limited Feb 14, 2025 |
| K243503 — VIA360 Surgical System | New World Medical, Inc. Feb 14, 2025 |
| K241527 — Pastelle Pro | Wontech Co., Ltd. Feb 14, 2025 |
| K242198 — ICS Dizcovery (1091) | Natus Medical Denmark Aps Feb 14, 2025 |
| K250248 — BriefCase-Triage | Aidoc Medical , Ltd. Feb 14, 2025 |
| K243136 — Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) | Shenzhen Finicare Co., Ltd. Feb 14, 2025 |
| K241573 — Alinity m Resp-4-Plex | Abbott Molecular, Inc. Feb 14, 2025 |
| K242593 — CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Feb 14, 2025 |
| K242776 — LimFlow V-Ceiver | LimFlow, Inc. Feb 14, 2025 |
| K242104 — Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. Feb 13, 2025 |
| K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | Assure Tech., LLC Feb 13, 2025 |