| K242731 — MasteRad MiniX Mobile Digital Imaging System (Mini-X) | Medicatech USA, Inc. May 16, 2025 |
| K242585 — Cystatin C | SENTINEL CH. SpA May 16, 2025 |
| K242706 — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. May 16, 2025 |
| K250971 — Embosphere Microspheres | Biosphere Medical, S.A. May 16, 2025 |
| K243105 — Ruby Intravascular Catheter | Venocare, Inc. May 16, 2025 |
| K243617 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. May 16, 2025 |
| K244033 — Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) | Shenzhen Desida Technology Co., Ltd. May 16, 2025 |
| K241581 — Hemodialysis Catheter | Haolang Medical USA Corporation May 16, 2025 |
| K243371 — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 | Byonyks Pvt, Ltd. May 16, 2025 |
| K242438 — Clearo | Breas Medical AB May 16, 2025 |
| K250086 — OTS Hip | Ortoma AB May 16, 2025 |
| K251184 — AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System | Encore Medical L.P. May 16, 2025 |
| K243837 — iBSM | Iorbit Digital Technologies Private Limited May 16, 2025 |
| K240554 — InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. May 16, 2025 |
| K244008 — Spectral CT | Philips Medical Systems Technologies , Ltd. May 16, 2025 |
| K250141 — Synthecure Synthetic Calcium Sulfate | Austin Medical Ventures, Inc. May 16, 2025 |
| K243602 — Arthrex Spine Endoscope | Arthrex, Inc. May 16, 2025 |
| K243176 — BLESSING System | Cellah Medical Co., Ltd. May 16, 2025 |
| K243927 — MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG May 16, 2025 |
| K242569 — Mixed Reality Spine Navigation | Brainlab AG May 16, 2025 |
| K250099 — Mobius3D (4.1) | Varian Medical Systems May 16, 2025 |
| K250454 — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | Hardy Diagnostics May 15, 2025 |
| K243165 — Limfa Therapy System (Limfa Therapy) | Eywa Srl May 15, 2025 |
| K242519 — Lumify Diagnostic Ultrasound System | Philips Ultrasound May 15, 2025 |
| K242176 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) | NIKKISO CO., LTD. May 15, 2025 |
| K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | NIKKISO CO., LTD. May 15, 2025 |
| K250444 — NEXUS® Hip Stem | Microport Orthopedics, Inc. May 15, 2025 |
| K250432 — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) | Olympus Medical Systems Corporation May 15, 2025 |
| K250276 — Nitinol Enhanced Device (NED) | Embolization, Inc. May 15, 2025 |
| K250451 — NeurAxis IB-Stim (01-1020) | Neuraxis May 15, 2025 |
| K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | C.R. Bard, Inc. May 15, 2025 |
| K251156 — NPseal | Guard Medical, Inc. May 15, 2025 |
| K242479 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU | NIKKISO CO., LTD. May 15, 2025 |
| K240857 — Youmagic FLM System (YM5-U1) | We Medical Technology (Wuxi) Co., Ltd. May 15, 2025 |
| K242518 — Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC May 15, 2025 |
| K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) | Stryker Instruments May 15, 2025 |
| K242931 — HFT750U | Mekics Co., Ltd. May 15, 2025 |
| K250813 — MICROLET®NEXT 2 Lancing Device | Ascensia Diabetes Care U.S., Inc. May 14, 2025 |
| K243830 — Disposable ureteral stent | Shenzhen Trious Medical Technology Co., Ltd. May 14, 2025 |
| K250414 — CaloPix | Tribun Health May 14, 2025 |
| K242072 — CeraRoot TL Implant System (TL) | Ceraroot SL May 14, 2025 |
| K250533 — Magnesium alloy scooter (RS100) | Taizhou Reach Technology Co., Ltd. May 14, 2025 |
| K250420 — Helios Dura Regeneration Matrix | Helios Biomedical, Inc. May 14, 2025 |
| K251288 — Veincare | Wontech Co., Ltd. May 14, 2025 |
| K250405 — Nerivio; Nerivio Infinity | Theranica Bio-Electronics, Ltd. May 14, 2025 |
| K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery, LLC May 14, 2025 |
| K242624 — Medical Image Post-processing Software (uOmnispace.CT) | Shanghai United Imaging Healthcare Co., Ltd. May 14, 2025 |
| K250041 — Medical Picosecond ND: YAG Laser System (PZ-6) | Zhengzhou PZ Laser Slim Technology Co., Ltd. May 14, 2025 |
| K250712 — Linkt Compression Staple System | Trax Surgical May 14, 2025 |
| K250775 — Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System | Imperative Care, Inc. May 14, 2025 |