| K243656 — U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella | United Orthopedic Corporation Jul 31, 2025 |
| K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer Biomet Jul 31, 2025 |
| K242728 — BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jul 31, 2025 |
| K243455 — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems | Roche Molecular Systems, Inc. Jul 31, 2025 |
| K250477 — NextAR(TM) Spine | Medacta International S.A. Jul 31, 2025 |
| K250597 — REMEX Xcam6 | Remedi, Inc. Jul 31, 2025 |
| K244060 — eCO2 3D | Lutronic Corporation Jul 31, 2025 |
| K241461 — Mpact Constrained Liner | Medacta International S.A. Jul 31, 2025 |
| K251561 — Biograph Trinion | Siemens Medical Solutions USA, Inc. Jul 31, 2025 |
| K243341 — Genius AI Detection 2.0 | Hologic, Inc. Jul 31, 2025 |
| K251574 — Sleep Watch | Ambulatory Monitoring, Inc. Jul 31, 2025 |
| DEN240068 — ArteraAI Prostate | Artera, Inc. Jul 31, 2025 |
| K250843 — Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) | Shenzhen TPH Technology Co., Ltd. Jul 31, 2025 |
| K250724 — Intraosseous Infusion Needles | Spectrum Vascular Jul 30, 2025 |
| K243919 — Voxel Dosimetry (00859873006226) | Hermes Medical Solutions AB Jul 30, 2025 |
| K251319 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Extended Cuff | Hartalega NGC Sdn. Bhd. Jul 30, 2025 |
| K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC Jul 30, 2025 |
| K241990 — SpineSite Endoscope System | Hydrocision, Inc. Jul 30, 2025 |
| K252144 — Iconix Speed Anchor; Iconix Speed HA+ Anchor | Riverpoint Medical Jul 30, 2025 |
| K242855 — P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | E.O.S Co., Ltd. Jul 30, 2025 |
| K251361 — Tyber Medical Distal Radius Plating System | Tyber Medical, LLC Jul 30, 2025 |
| K243534 — Micro Catheter | Suzhou Zenith Vascular SciTech Limited Jul 30, 2025 |
| K251060 — CORUS Navigation System-GX | Providence Medical Technology, Inc. Jul 30, 2025 |
| K251076 — Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) | Shenzhen Lifotronic Technology Co., Ltd. Jul 30, 2025 |
| K251234 — EnSite X EP System | ABBOTT MEDICAL Jul 30, 2025 |
| K251706 — TENS and EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. Jul 30, 2025 |
| K244007 — ArteVu | Cardio Ring Technologies, Inc. Taiwan Branch Jul 30, 2025 |
| K250127 — TSK Syringe | Tsk Laboratory, Japan Jul 30, 2025 |
| K252032 — T65 (9016E061-) | Tonica Elektronik A/S Jul 30, 2025 |
| K251350 — BD Plastipak Syringe | Becton, Dickinson And Company Jul 29, 2025 |
| K250647 — SImmetry+ System | Sivantage Jul 29, 2025 |
| K243473 — PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS | Prognosys Medical Systems Private Limited Jul 29, 2025 |
| K250442 — da Vinci Surgical System, IS5000 | Intuitive Surgical, Inc. Jul 29, 2025 |
| K251664 — Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | Olympus Medical Systems Corporation Jul 29, 2025 |
| K251523 — Cios Spin | Siemens Medical Solutions USA, Inc. Jul 29, 2025 |
| K243407 — Forcyte Autograft Harvest Kit | Forcyte Medical, LLC Jul 29, 2025 |
| K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. Jul 29, 2025 |
| K251364 — Sleepiz One+ (2.5) | Sleepiz AG Jul 29, 2025 |
| K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Infobionic, Inc. Jul 29, 2025 |
| K251220 — NUVENTUS NV.C Prosthetic Components | Infinitum Eta, Ltd. Jul 28, 2025 |
| K243489 — Alinity m EBV (09N43-095) | Abbott Molecular, Inc. Jul 28, 2025 |
| K250652 — ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. Jul 28, 2025 |
| K251061 — NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. Jul 28, 2025 |
| K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Baxter Healthcare Corporation Jul 28, 2025 |
| K241183 — ISO Abutment | Seum Medi Co., Ltd. Jul 28, 2025 |
| K251187 — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | Changsha Anxiang Medical Technology Co., Ltd. Jul 28, 2025 |
| K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation Jul 28, 2025 |
| K252215 — InbellaMAX System | Inbella Medical , Ltd. Jul 25, 2025 |
| K251339 — Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) | Zhengzhou PZ Laser Slim Technology Co., Ltd. Jul 25, 2025 |
| K251322 — Venue; Venue Go; Venue Fit; Venue Sprint | GE Medical Systems Ultrasound And Primary Care Diagnostics Jul 25, 2025 |