| K242115 — Plum Duo Precision IV Pump | Icu Medical, Inc. Apr 2, 2025 |
| K250760 — SPECTRUM GV Bone Cement | Osteoremedies, LLC Apr 2, 2025 |
| K242031 — Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) Apr 2, 2025 |
| K242117 — LifeShield Infusion Safety Software Suite | Icu Medical, Inc. Apr 2, 2025 |
| K250677 — LEGION Total Knee System | Smith & Nephew, Inc. Apr 2, 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 |
| 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 |
| K250189 — AdvaTx | Advalight Aps Apr 1, 2025 |
| K242427 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. Apr 1, 2025 |
| K242925 — MR Contour DL | GE Healthcare Apr 1, 2025 |
| K250018 — Medical Diode Laser Systems (THEIA808) | Gigaalaser Company , 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 |
| K242105 — SABA Tampons | Essity Higiene Y Salud Mexico. S.A. DE C.V. Apr 1, 2025 |
| K250623 — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. 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 |
| K242041 — STOPWET iontophoresis apparatus (SW01) | Taiwan Medical Electronics Co., Ltd. Apr 1, 2025 |
| K243384 — Belzer UW® Cold Storage Solution (BTLBUW-001) | Bridge TO Life Mar 31, 2025 |
| K250663 — Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. Mar 31, 2025 |
| K242166 — TribusConnect | Tribusmed Beheer BV 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 |
| K250263 — Disposable Grasping Forceps FG-52D/FG-54D | Olympus Medical Systems Corp. Mar 31, 2025 |
| K242618 — Layer 7-T | Precision Neuroscience, Corp. Mar 30, 2025 |
| K250601 — Neuro Omega System; NeuroSmart System | Alpha Omega Engineering , Ltd. Mar 30, 2025 |
| K233953 — Makani Science Respiration Monitoring System | Makani Science, Inc. Mar 28, 2025 |
| K243520 — Bullsai Confirm | Turing Medical Technologies, Inc. Mar 28, 2025 |
| DEN240020 — Visby Medical Women's Sexual Health Test | Visby Medical, Inc. Mar 28, 2025 |
| K244030 — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | Wuxi Jiajian Medical Instrument Co., Ltd. Mar 28, 2025 |
| K250571 — CATALYSTEM Femoral Stems | Smith & Nephew, Inc. Mar 28, 2025 |
| K244044 — PBC Separator with Selux AST System | Selux Diagnostics, Inc. Mar 28, 2025 |
| K241927 — Synthes Graphic Case & Tray System | Synthes GmbH Mar 28, 2025 |
| K242952 — INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH Mar 28, 2025 |
| K250596 — Arthrex FiberTak Suture Anchor | Arthrex, Inc. Mar 28, 2025 |
| K243228 — Flexi-Seal AIR (with ENFit Connector) | Convatec Mar 28, 2025 |
| K242022 — Access Toxo IgG | Beckman Coulter, Inc. Mar 28, 2025 |
| K234067 — ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) | Medphoton GmbH Mar 28, 2025 |
| K243708 — Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) | Scivita Medical Technology Co., Ltd. Mar 27, 2025 |
| K242919 — V5med Lung AI | V5Med, Inc. Mar 27, 2025 |
| K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) | Access Vascular, Inc. Mar 27, 2025 |
| K250555 — MallyaD injection pen adapter (MallyaD) | Biocorp Production Mar 27, 2025 |
| K250092 — HC Biologics Osteopoint Spinal Fixation System | HC Biologics, LLC Mar 27, 2025 |
| K241962 — Crossloop | Asahi Intecc Co., Ltd. Mar 27, 2025 |
| K243038 — Salix Central | Artrya Limited Mar 27, 2025 |
| K250558 — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | Medtronic, Inc. Mar 27, 2025 |
| K244046 — Edwards eSheath Optima introducer set | Edwards Lifesciences Mar 27, 2025 |
| K243426 — Nurochek-Pro System | Headsafe Mfg Pty, Ltd. Mar 27, 2025 |
| K242201 — HyperSuture White/Green Extension Line | Threadstone, LLC Mar 27, 2025 |
| K243768 — iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. Mar 27, 2025 |
| K241862 — Levina Pelvic Floor Muscle Stimulator (RS-48) | Zmi Electronics , Ltd. Mar 27, 2025 |