| 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 |
| K250053 — TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | Shenzhen Jiantuo Electronics Co., Ltd. May 9, 2025 |
| K251126 — SKOUT system | Iterative Health May 9, 2025 |
| K242732 — Tristel OPH | Tristel Solutions , Ltd. May 9, 2025 |
| K243107 — Water Solubility Human Body Lubricant | Dongguan Yanxuan Biotechnology Co., Ltd. May 9, 2025 |
| K251110 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC May 9, 2025 |
| K251103 — VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) | Philips Image Guided Therapy Corporation May 9, 2025 |
| K250758 — Electric Wheelchair (F309) | Changshu Pingfang Wheelchair Co., Ltd. May 9, 2025 |
| K242388 — LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. May 9, 2025 |
| K243322 — Altaviz Intravitreal Syringe | Altaviz, LLC May 9, 2025 |
| K250400 — Vigeon Laparoscopic Universal Smoke Evacuator (VG003) | Vigeon Technology Co., Ltd. May 9, 2025 |
| K243812 — Volta AF-Xplorer | Volta Medical May 9, 2025 |
| K251425 — turbodent touch | Mectron S.P.A. May 9, 2025 |
| K241086 — Avidhrt Sense SpO2 | Avidhrt, Inc. May 9, 2025 |
| K242692 — SteadiSet Infusion Set | Capillary Biomedical, LLC May 9, 2025 |
| K243290 — BTL-785MJ | BTL Industries, Inc. May 9, 2025 |
| K242392 — PATH BGC | Crossroads Neurovascular, Inc. May 9, 2025 |
| K243230 — Second Opinion® BLE | Pearl, Inc. May 9, 2025 |
| K250299 — CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. May 9, 2025 |
| K243764 — Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) | Wuhan Pioon Technology Co., Ltd. May 8, 2025 |
| K242670 — Lumify Diagnostic Ultrasound System | Philips Ultrasound May 8, 2025 |
| K243110 — eFOLDi Navigator Powerchair (STPC-A) | Suntech UK , Ltd. May 8, 2025 |
| K250226 — Clarius Median Nerve AI | Clarius Mobile Health Corp. May 8, 2025 |
| K250482 — Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | Fissiontech, LLC May 8, 2025 |
| K243824 — Preat Abutments | Preat Corporation May 8, 2025 |
| K243419 — Altus Spine Navigation System | Altus Partners, LLC May 8, 2025 |
| K243226 — Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) | Leltek, Inc. May 8, 2025 |
| K242410 — NextStep Arthropedix Total Knee System | Nextstep Arthropedix May 8, 2025 |
| K250582 — COLONNADE Posterior Screw Fixation System | CG Bio Co., Ltd. May 8, 2025 |