| K250998 — CO2 Laser Therapy System (Model: LFS-D9U) | Sanhe Lefis Electronics Co., Ltd. Dec 19, 2025 |
| K252754 — Wearable Electric Breast Pump (YM-8803) | Guangdong Youmeng Electrical Technology Co., Ltd. Dec 19, 2025 |
| K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) | Ningbo Ranor Medical Science & Technology Co., Ltd. Dec 19, 2025 |
| K252284 — eMurmur Heart AI | Csd Labs Dec 19, 2025 |
| K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | Fisher & Paykel Healthcare, Ltd. Dec 19, 2025 |
| K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. Dec 19, 2025 |
| K251572 — eRapid with eTrack System | Pari Respiratory Equipment, Inc. Dec 19, 2025 |
| K253161 — Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. Dec 19, 2025 |
| K251152 — DBLG2 | Diabeloop Dec 19, 2025 |
| K251077 — JOULE 1064nm System and Accessories | Sciton, Inc Dec 19, 2025 |
| K254063 — iCEM Universal Plus | Kulzer, LLC Dec 19, 2025 |
| K253733 — STAR Apollo Mapping System | Rhythm AI, Ltd. Dec 19, 2025 |
| K251469 — Endura Ureteral Stent and Stent Set | Cathegenix (Xiamen) Co., Ltd. Dec 19, 2025 |
| K252877 — SANDRO Dual | Wontech Co., Ltd. Dec 19, 2025 |
| K252974 — EMPOWR Knee | Encore Medical L.P. Dec 19, 2025 |
| K252781 — MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. Dec 19, 2025 |
| K253054 — LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. Dec 19, 2025 |
| K251402 — LIA-1 Catheter (542-1) | Leadoptik, Inc. Dec 19, 2025 |
| K252780 — LCD Monitor (CL1902A, CL2103F) | Shenzhen Beacon Display Technology Co., Ltd. Dec 19, 2025 |
| K250864 — MatriDerm pluS+ Bi-Layer | Medskin Solutions Dr. Suwelack AG Dec 19, 2025 |
| K253373 — Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. Dec 19, 2025 |
| K252863 — ClearCalc Model RADCA V2.6 | Radformation, Inc. Dec 19, 2025 |
| K251011 — Chiavaye Personal Moisturizer | Unipack, LLC Dec 19, 2025 |
| K253616 — ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. Dec 19, 2025 |
| K252976 — Park Dental Nylon MAD | Park Dental Research Corp. Dec 18, 2025 |
| K252402 — Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. Dec 18, 2025 |
| K252348 — Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation Dec 18, 2025 |
| K252793 — ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) | Jiangsu Jiyuan Medical Technology Co., Ltd. Dec 18, 2025 |
| K252956 — Helo Thrombectomy System | Endovascular Engineering, Inc. Dec 18, 2025 |
| K252235 — PVAD IQ Software | Ultrasight , Ltd. Dec 18, 2025 |
| K253518 — FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC Dec 18, 2025 |
| K252071 — RefleXion Medical Radiotherapy System, Reflexion X2 | Reflexion Medical, Inc. Dec 18, 2025 |
| K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences Dec 18, 2025 |
| K250914 — MediAI-BA | Crescom Co., Ltd. Dec 18, 2025 |
| K252320 — SIMDA Abutments | Simda Co., Ltd. Dec 18, 2025 |
| K253915 — MOVIVA® Hybrid Ablation Probe | Erbe Elektromedizin GmbH Dec 18, 2025 |
| K253758 — Dental Cone; Dental Sponge | Medizin Produkte Neustadt GmbH (Mpn) Dec 18, 2025 |
| K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG Dec 18, 2025 |
| K253516 — Assert-IQ (DM5100) | ABBOTT MEDICAL Dec 18, 2025 |
| K250993 — Single Use Cytology Brush V (BC-V600P-3010) | Olympus Medical Systems Corporation Dec 18, 2025 |
| K251915 — Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. Dec 18, 2025 |
| K253093 — Vital Spinal Fixation System | Highridge Medical, LLC Dec 17, 2025 |
| K252922 — Neosoma Brain Mets | Neosoma, Inc. Dec 17, 2025 |
| K253719 — Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. Dec 17, 2025 |
| K252983 — Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) | Shenzhen Goodwind Technology Development Co., Ltd. Dec 17, 2025 |
| K253710 — Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. Dec 17, 2025 |
| K252417 — Amplatzer Piccolo Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL Dec 17, 2025 |
| K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O Dec 17, 2025 |
| K253839 — Elecsys Anti-SARS-CoV-2 | Roche Diagnostics Dec 17, 2025 |
| K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T) | Ethicon Endo-Surgery, LLC Dec 17, 2025 |