| K250053 — TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | Shenzhen Jiantuo Electronics Co., Ltd. May 9, 2025 |
| K251126 — SKOUT system | Iterative Health May 9, 2025 |
| K242732 — Tristel OPH | Tristel Solutions , Ltd. May 9, 2025 |
| K243107 — Water Solubility Human Body Lubricant | Dongguan Yanxuan Biotechnology Co., Ltd. May 9, 2025 |
| K251110 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC May 9, 2025 |
| K251103 — VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) | Philips Image Guided Therapy Corporation May 9, 2025 |
| K250758 — Electric Wheelchair (F309) | Changshu Pingfang Wheelchair Co., Ltd. May 9, 2025 |
| K242388 — LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. May 9, 2025 |
| K243322 — Altaviz Intravitreal Syringe | Altaviz, LLC May 9, 2025 |
| K250400 — Vigeon Laparoscopic Universal Smoke Evacuator (VG003) | Vigeon Technology Co., Ltd. May 9, 2025 |
| K243812 — Volta AF-Xplorer | Volta Medical May 9, 2025 |
| K251425 — turbodent touch | Mectron S.P.A. May 9, 2025 |
| K241086 — Avidhrt Sense SpO2 | Avidhrt, Inc. May 9, 2025 |
| K242692 — SteadiSet Infusion Set | Capillary Biomedical, LLC May 9, 2025 |
| K243290 — BTL-785MJ | BTL Industries, Inc. May 9, 2025 |
| K242392 — PATH BGC | Crossroads Neurovascular, Inc. May 9, 2025 |
| K243230 — Second Opinion® BLE | Pearl, Inc. May 9, 2025 |
| K250299 — CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. May 9, 2025 |
| K243764 — Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) | Wuhan Pioon Technology Co., Ltd. May 8, 2025 |
| K242670 — Lumify Diagnostic Ultrasound System | Philips Ultrasound May 8, 2025 |
| K243110 — eFOLDi Navigator Powerchair (STPC-A) | Suntech UK , Ltd. May 8, 2025 |
| K250226 — Clarius Median Nerve AI | Clarius Mobile Health Corp. May 8, 2025 |
| K250482 — Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | Fissiontech, LLC May 8, 2025 |
| K243824 — Preat Abutments | Preat Corporation May 8, 2025 |
| K243419 — Altus Spine Navigation System | Altus Partners, LLC May 8, 2025 |
| K243226 — Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) | Leltek, Inc. May 8, 2025 |
| K242410 — NextStep Arthropedix Total Knee System | Nextstep Arthropedix May 8, 2025 |
| K250582 — COLONNADE Posterior Screw Fixation System | CG Bio Co., Ltd. May 8, 2025 |
| K251133 — AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. May 8, 2025 |
| K233271 — OsseOne Dental Implant System | Synoross Dba Osseone May 8, 2025 |
| K251128 — Extremity Medical External Fixation System | Extremity Medical, LLC May 7, 2025 |
| K251111 — Cary | Excitus AS May 7, 2025 |
| K243684 — BrightHeart View Classifier | Brightheart May 7, 2025 |
| K250222 — SDF Pro | Belport Company, Inc., Gingi-Pak May 7, 2025 |
| K242975 — Mobility Scooter (Model X-01, X-02) | Wuyi Aichi Industry & Trade Co., Ltd. May 7, 2025 |
| K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | Zeus Scientific May 7, 2025 |
| K241980 — !M1 | Solutions For Tomorrow AB May 6, 2025 |
| K250785 — Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. May 6, 2025 |
| K251094 — Alma Veil | Wontech Co., Ltd. May 6, 2025 |
| K250160 — ANKYRAS | Mentice Spain S.L. May 6, 2025 |
| K243017 — IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D) | Foshan Newface Electronic Technology Co., Ltd. May 6, 2025 |
| K250253 — IPL Hair Removal Device (KCA511/KCA516/KCA522) | Dongguan Boyuan Intelligent Technology Co.,Ltd May 6, 2025 |
| K240447 — ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) | Thermasolutions, LLC May 5, 2025 |
| K242386 — Bluemoon | Genoss Co., Ltd. May 5, 2025 |
| K243603 — AeviceMD | Aevice Health Pte. , Ltd. May 5, 2025 |
| K242754 — ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | Zamar Medical D.O.O. May 5, 2025 |
| K242962 — Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH May 5, 2025 |
| K250728 — Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. May 5, 2025 |
| K243370 — DentaTOOTH | Asiga Pty, Ltd. May 5, 2025 |
| K242937 — Dream Medi Sterile Surgical Gown (SurgicalGownUL) | Dae Myung Chemical Co., Ltd. (Vietnam) May 5, 2025 |