| K242209 — UASure II Blood Uric Acid Monitoring System | Apex BioTechnology Corp. Apr 4, 2025 |
| K242551 — syngo Dynamics (Version VA41D) | Siemens Healthcare GmbH Apr 3, 2025 |
| K243298 — Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System | Carbon (Shenzhen) Medical Device Co., Ltd. Apr 3, 2025 |
| K250404 — staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch | Fresenius Medical Care Renal Therapies Group, LLC Apr 3, 2025 |
| K243760 — OSSIOfiber® Suture Anchor 2.5-3.5 mm | OSSIO , Ltd. Apr 3, 2025 |
| K243514 — Salvo® Robotic Navigation Instruments | Spine Wave, Inc. Apr 3, 2025 |
| K242358 — Powered wheelchair (mobility robot) (M4, M4U) | Xsto Co., Ltd. Apr 3, 2025 |
| K243936 — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. Apr 3, 2025 |
| K243305 — Masimo W1 | Masimo Corporation Apr 3, 2025 |
| K250658 — SureFine Pen Needle | Shina Med Corporation Apr 3, 2025 |
| K240615 — Leos Laser and Endoscopy System | Beaver-Visitec International, Inc. Apr 3, 2025 |
| K243889 — Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) | Orthocell, Ltd. Apr 2, 2025 |
| K243733 — SION blue PLUS | Asahi Intecc Co., Ltd. Apr 2, 2025 |
| K242113 — Nerve Wrap (07-DW-001-TAB) | Biocircuit Technologies, Inc. Apr 2, 2025 |
| K250705 — Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. Apr 2, 2025 |
| K241984 — Hi-D Imaging 4TAVR | Hi-D Imaging AG Apr 2, 2025 |
| K242115 — Plum Duo Precision IV Pump | Icu Medical, Inc. Apr 2, 2025 |
| K242031 — Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) Apr 2, 2025 |
| K242460 — Progenix Select Stim | Progenix, LLC Apr 2, 2025 |
| K250138 — Small Volume 0.2mL Syringe | Prosum Medical Limited Apr 2, 2025 |
| K250677 — LEGION Total Knee System | Smith & Nephew, Inc. Apr 2, 2025 |
| K243659 — FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | SeaSpine Orthopedics Corporation Apr 2, 2025 |
| K242067 — VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA | Olympus Corporations Of The Americas Apr 2, 2025 |
| K250930 — twiist system | Deka Research & Development Corp. Apr 2, 2025 |
| K250760 — SPECTRUM GV Bone Cement | Osteoremedies, LLC Apr 2, 2025 |
| K242117 — LifeShield Infusion Safety Software Suite | Icu Medical, Inc. Apr 2, 2025 |
| K250613 — SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. Apr 2, 2025 |
| K250152 — eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; | Shenzhen TPH Technology Co., Ltd. Apr 2, 2025 |
| K242114 — Plum Solo Precision IV Pump | Icu Medical, Inc. Apr 2, 2025 |
| K242427 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. Apr 1, 2025 |
| K250623 — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. Apr 1, 2025 |
| K242105 — SABA Tampons | Essity Higiene Y Salud Mexico. S.A. DE C.V. Apr 1, 2025 |
| K242925 — MR Contour DL | GE Healthcare Apr 1, 2025 |
| K242041 — STOPWET iontophoresis apparatus (SW01) | Taiwan Medical Electronics Co., Ltd. Apr 1, 2025 |
| K250018 — Medical Diode Laser Systems (THEIA808) | Gigaalaser Company , Ltd. Apr 1, 2025 |
| K250189 — AdvaTx | Advalight Aps Apr 1, 2025 |
| K250578 — Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | Careglove Global Sdn. Bhd. Apr 1, 2025 |
| K243072 — Préime DermaFacial (MicroT) | EMA Aesthetics , Ltd. Apr 1, 2025 |
| K243938 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire | Scientia Vascular, Inc. Apr 1, 2025 |
| K250263 — Disposable Grasping Forceps FG-52D/FG-54D | Olympus Medical Systems Corp. Mar 31, 2025 |
| K250663 — Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. Mar 31, 2025 |
| K243384 — Belzer UW® Cold Storage Solution (BTLBUW-001) | Bridge TO Life Mar 31, 2025 |
| K250946 — Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd. Mar 31, 2025 |
| K243178 — Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di | Shantou Institute Of Ultrasonic Instruments Co., Ltd. Mar 31, 2025 |
| K242166 — TribusConnect | Tribusmed Beheer BV Mar 31, 2025 |
| K250601 — Neuro Omega System; NeuroSmart System | Alpha Omega Engineering , Ltd. Mar 30, 2025 |
| K242618 — Layer 7-T | Precision Neuroscience, Corp. Mar 30, 2025 |
| K250571 — CATALYSTEM Femoral Stems | Smith & Nephew, Inc. Mar 28, 2025 |
| K243520 — Bullsai Confirm | Turing Medical Technologies, Inc. Mar 28, 2025 |
| K243228 — Flexi-Seal AIR (with ENFit Connector) | Convatec Mar 28, 2025 |