| 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 |
| K242437 — Smile Dx® | Cube Click, Inc. May 14, 2025 |
| K251138 — Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. May 13, 2025 |
| K242762 — Aesculap Aicon® Series Container System | Aesculap, Inc. May 13, 2025 |
| K250786 — SP Endoscope, 0° (430600) | Intuitive Surgical, Inc. May 13, 2025 |
| K250418 — Ulthera System (UC-1 Control Unit PRIME Model 2.1) | Ulthera, Inc. May 13, 2025 |
| K242674 — Freedom Posterior Cervical Screws | Signature Orthopaedics Pty, Ltd. May 13, 2025 |
| K242808 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 | Canon Medical Systems Corporation May 13, 2025 |
| K250763 — Reon | C.E.I.B.Med May 12, 2025 |
| K242418 — P-Cure Proton Therapy System (PPTS) | P-Cure, Ltd. May 12, 2025 |
| K250431 — Medical Diode Laser Hair Removal System (MNLT-D1) | Shandong Moonlight Electronics Tech Co., Ltd. May 12, 2025 |
| K250592 — NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | Northeast Scientific, Inc. May 12, 2025 |
| K244050 — AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation May 12, 2025 |
| K250868 — SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH May 12, 2025 |
| K250393 — ZircaGlow & ZircaGlow HT Zirconia | United Zirconia May 12, 2025 |
| K242477 — Shoulder Soft Tissue Anchors | Signature Orthopaedics Pty, Ltd. May 12, 2025 |
| K250421 — InThrill Thrombectomy System | Inari Medical, Inc. May 12, 2025 |
| K243509 — Archer PSI System | 3D-Side May 12, 2025 |
| K243632 — uWS-Angio Basic | Shanghai United Imaging Healthcare Co., Ltd. May 12, 2025 |
| K250360 — TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) | Shenzhen Jiantuo Electronics Co., Ltd. May 11, 2025 |
| K250377 — Flowflex Plus COVID-19 + Flu A/B Home Test | ACON Laboratories, Inc. May 10, 2025 |
| K242294 — DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls | Diasys Diagnostic Systems GmbH May 9, 2025 |
| DEN240045 — Teal Wand | Teal Health, Inc. May 9, 2025 |