| K243505 — 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC May 30, 2025 |
| K250317 — EsFlow PLUS | Spident Co., Ltd. May 30, 2025 |
| K250368 — Wearable Breast Pump (Model S21) | Shenzhen TPH Technology Co., Ltd. May 30, 2025 |
| K243863 — Opulus Lymphoma Precision | Roche Molecular Systems, Inc. May 30, 2025 |
| K243522 — ViVi® Toga Premium | Thi Total Healthcare Innovation GmbH May 30, 2025 |
| K243530 — Dynamic TiBase | Talladium España, SL May 30, 2025 |
| K250236 — Swoop® Portable MR Imaging® System (V2) | Hyperfine, Inc. May 30, 2025 |
| K251383 — Prestige Coil System (Prestige Packing Line Extension) | Balt USA, LLC May 30, 2025 |
| K242640 — FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin | Fertipro NV May 30, 2025 |
| K251340 — ProSeal Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte. , Ltd. May 29, 2025 |
| K250215 — Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | Cochlear May 29, 2025 |
| K251315 — Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II | Remex Medical Corp. May 29, 2025 |
| K243372 — BiliWrap | Gerium Medical, Ltd. May 29, 2025 |
| K250048 — NEUROMARK System (NMK00301) | Neurent Medical , Ltd. May 29, 2025 |
| K243497 — Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US | Shanghai AnQing Medical Instrument Co., Ltd. May 29, 2025 |
| K250673 — CERABIEN MiLai | Kuraray Noritake Dental, Inc. May 29, 2025 |
| K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422) | Medtronic Navigation May 29, 2025 |
| K250543 — Voluson Performance 16; Voluson Performance 18 | GE Medical Systems Ultrasound And Primary Care Diagnostics May 29, 2025 |
| K250757 — Radius VSM and Accessories | Masimo Corporation May 29, 2025 |
| K251325 — VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. May 29, 2025 |
| K243856 — TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) | Shenzhen Astec Technology Co., Ltd. May 29, 2025 |
| K250606 — Dental Barrier and Sleeves | Yueying Medical Instruments (Langfang) Co., Ltd. May 29, 2025 |
| DEN240048 — Spur Peripheral Retrievable Stent System | Reflow Medical, Inc. May 29, 2025 |
| K243480 — SuturePatch Tissue Reinforcement | Arthrex, Inc. May 29, 2025 |
| K243484 — PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. May 29, 2025 |
| K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. May 29, 2025 |
| K243469 — SIGNEX | Osteonic Co., Ltd. May 29, 2025 |
| K242752 — MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation May 28, 2025 |
| K243716 — Zionic Pro Max (Radiofrequency) | Termosalud S.L. May 28, 2025 |
| K242699 — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) | Opcom Medical, Inc. May 28, 2025 |
| K250367 — CoLumboX | Smart Soft Healthcare AD May 28, 2025 |
| K244049 — Europa (Alternative: AiRTouch) portable X-ray system | Livermoretech, Inc. May 28, 2025 |
| K243949 — OsteoFlo HydroFiber | SurGenTec, LLC May 28, 2025 |
| K243047 — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | Imperative Care, Inc. May 28, 2025 |
| K250624 — myAir | Resmed Corp May 28, 2025 |
| K251344 — OptiMap System | Boston Scientific Corporation May 28, 2025 |
| K243378 — Rapid MLS | Ischemaview, Inc. May 28, 2025 |
| K242793 — Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters Insight Workstation iS-PF1. | Shenzhen Insighters Medical Technology Co., Ltd. May 28, 2025 |
| K250427 — TAIMedImg DeepMets | Taiwan Medical Imaging Co., Ltd. May 28, 2025 |
| K240950 — Disposable Prophy Angle | Pacific Care Limited May 28, 2025 |
| K250475 — Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) | Ningbo Baichen Medical Devices Co., Ltd. May 27, 2025 |
| K242611 — Integral Dental Units | Mipont Medical Equipment Co., Ltd. May 27, 2025 |
| K243777 — Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum) | Theodent, LLC May 27, 2025 |
| K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | ABBOTT MEDICAL May 27, 2025 |
| K250932 — DeepRhythmAI | Medicalgorithmics S.A. May 27, 2025 |
| K242604 — Helios+ UV-C System | Preventamed Technologies, Inc. Dba Surfacide Manufacturing May 27, 2025 |
| K251578 — BEAUTIFIL II | Shofu Dental Corporation May 27, 2025 |
| K251309 — OSSIOfiber® Suture Anchor | OSSIO , Ltd. May 27, 2025 |
| K250614 — Neodent Implant System - Custom Abutments | Jjgc Indústria E Comércia DE Materiais Dentários S.A. May 27, 2025 |
| K250573 — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M | Olympus Medical Systems Corp. May 27, 2025 |