| K252529 — Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120) | Boston Scientific Corporation Oct 30, 2025 |
| K250632 — Arctx Cool Catheter Set | Arctx Medical Oct 30, 2025 |
| K252430 — Freeprint® denture flex | Detax GmbH Oct 30, 2025 |
| K252414 — Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Oct 30, 2025 |
| K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. Oct 30, 2025 |
| K252387 — Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) | Diasorin Molecular, LLC Oct 30, 2025 |
| K253376 — OBSIDIO Conformable Embolic (M0013972101010) | Boston Scientific Corporation Oct 30, 2025 |
| K253327 — HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. Oct 30, 2025 |
| K252607 — AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. Oct 30, 2025 |
| K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. Oct 29, 2025 |
| K251772 — Navilas Laser System 577sl (156691) | Od-Os GmbH Oct 29, 2025 |
| K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. Oct 29, 2025 |
| K253283 — Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) | Shenzhen Root Innovation Technology Co., Ltd. Oct 29, 2025 |
| K251963 — LOGIQ E10s | GE Medical Systems Ultrasound And Primary Care Diagnostics Oct 29, 2025 |
| K253355 — Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC Oct 29, 2025 |
| K250316 — Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC Oct 29, 2025 |
| K252697 — 3D Laparoscope | Guangdong Optomedic Technologies, Inc. Oct 29, 2025 |
| K250882 — SANSA HSAT | Huxley Medical Oct 29, 2025 |
| K251985 — LOGIQ E10 | GE Medical Systems Ultrasound And Primary Care Diagnostics Oct 29, 2025 |
| K253345 — JARVIS Diaphyseal Stem Standard | FH Industrie Oct 29, 2025 |
| K253314 — Freedom Infinia Total Knee System | Maxx Orthopedics, Inc. Oct 29, 2025 |
| K252314 — Arthrex SutureTak Suture Anchor | Arthrex, Inc. Oct 29, 2025 |
| K253232 — Seguin Annuloplasty Ring | ABBOTT MEDICAL Oct 29, 2025 |
| K252390 — Telescope Guide Extension Catheter | Medtronic, Ireland Oct 29, 2025 |
| K250618 — Medi Lift Essential Eye Mask | Ya-Man, Ltd. Oct 29, 2025 |
| K251643 — Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) Oct 29, 2025 |
| K253153 — SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC Oct 29, 2025 |
| K253323 — Protrieve Sheath | Inari Medical Oct 29, 2025 |
| K253242 — LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. Oct 29, 2025 |
| K252376 — Yomi S Robotic System | Neocis, Inc. Oct 28, 2025 |
| K252351 — UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. Oct 28, 2025 |
| K252547 — TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation Oct 28, 2025 |
| K253399 — Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter | Volcano Corporation (Dba Philips Image Guided Therapy Device Oct 28, 2025 |
| K252165 — ZIRCONOMER P | Shofu Dental Corporation Oct 28, 2025 |
| K251466 — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr | Wellell, Inc. Oct 28, 2025 |
| K250275 — PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch | Baylis Medical Technologies, Inc. Oct 28, 2025 |
| K253300 — Fine Osteotomy | Bodycad Laboratories, Inc. Oct 28, 2025 |
| K252742 — Navigated Instruments | Tyber Medical, LLC Oct 28, 2025 |
| K250297 — TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. Oct 27, 2025 |
| K251027 — cvi42 Coronary Plaque Software Application | Circle Cardiovascular Imaging, Inc. Oct 27, 2025 |
| K252629 — Electric Breast Pump (HL-3058, F5112) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. Oct 27, 2025 |
| K251875 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC Oct 27, 2025 |
| K251824 — Patriot Duo | Patriot Laser, LLC Oct 27, 2025 |
| K252467 — Disposable Vinyl Examination Gloves | Viet Phu Trade And Import Export Co., Ltd. Oct 27, 2025 |
| K250520 — OsteoCentric Navigated Instruments System | Osteocentric Technologies, Inc. Oct 27, 2025 |
| K251331 — Blood Pressure Monitor (B73, BE23T) | Shenzhen Jamr Technology Co., Ltd. Oct 27, 2025 |
| K252053 — VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) | Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd Oct 27, 2025 |
| K252630 — Electric Breast Pump (HL-3060, F5113) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. Oct 27, 2025 |
| K251710 — Mobile X-ray unit (!M1) | Solutions For Tomorrow AB Oct 24, 2025 |
| K251372 — VersaD Delivery Catheter | Unity Medical, Inc. Oct 24, 2025 |