| K250625 — Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) | Nanjing Yinuoji Medical Technology Co., Ltd. Aug 27, 2025 |
| K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) | Donnevie Medical Technology (Shanghai) Co. , Ltd. Aug 27, 2025 |
| K252526 — Rapid DeltaFuse | Ischemaview, Inc. Aug 26, 2025 |
| K244061 — X-Wire Guidewire | Imperative Care, Inc. Aug 26, 2025 |
| K250049 — Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) | Seplou (Zhuhai) Co., Ltd. Aug 26, 2025 |
| K250261 — Heager Medical Laser Family (Sabrina/Adolf) | Heager GmbH Aug 26, 2025 |
| K251983 — Brainomix 360 Triage Stroke | Brainomix Limited Aug 26, 2025 |
| K251305 — Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation Aug 26, 2025 |
| K243834 — NobelZygoma TiUltra Implant system | Nobel Biocare AB Aug 25, 2025 |
| K251811 — Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. Aug 25, 2025 |
| K251440 — CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. Aug 25, 2025 |
| K251593 — DenMat Multilayered Zirconia Disc | Denmat Holding, LLC Aug 25, 2025 |
| K251246 — Sparrow Ascent | Spark Biomedical, Inc. Aug 25, 2025 |
| K243709 — NeuroEars-Anna | Neuroears, Inc. Aug 25, 2025 |
| K243800 — PRO Pen Microneedling System (6883) | Dermalogica, LLC Aug 25, 2025 |
| K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. Aug 25, 2025 |
| K243680 — Neurovascular Insight V1.0 | Olea Medical S.A.S. Aug 25, 2025 |
| K251404 — Quantra QStat Cartridge | Hemosonics, LLC Aug 25, 2025 |
| K252362 — GBrain MRI | Galileo Cds, Inc. Aug 22, 2025 |
| K250147 — CPS Locator 3D Delivery Catheter | Centerpoint Systems Aug 22, 2025 |
| K251277 — CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. Aug 22, 2025 |
| K251828 — CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. Aug 22, 2025 |
| K251604 — CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | Access Bio, Inc. Aug 22, 2025 |
| K243660 — Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe, Luer-Lock Tip (1180300777); Monoject 6mL Syringe, Luer-Lock Tip (1180600777); Monoject 12mL Syringe, Luer-Lock Tip (1181200777); Monoject 20mL Syringe, Luer-Lock Tip (1182000777); Monoject 35mL Syringe, Luer-Lock Tip (1183500777); Monoject 60mL Syringe, Luer-Lock Tip (1186000777); Monoject 3mL Syringe, Luer-Lock Tip (8881513934); Monoject 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | Cardinalhealth Aug 22, 2025 |
| K251884 — One-Fil Putty Injectable | Mediclus Co., Ltd. Aug 22, 2025 |
| K252303 — Stem Extension Line (USTAR II System) | United Orthopedic Corporation Aug 22, 2025 |
| K252302 — CARTO 3 EP Navigation System V8.1 | Biosense Webster, Inc. Aug 22, 2025 |
| K251192 — Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Aug 22, 2025 |
| K243692 — EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. Aug 22, 2025 |
| K243685 — MammoScreen BD | Therapixel Aug 22, 2025 |
| K251443 — PROMO | DRGEM Corporation Aug 22, 2025 |
| K243965 — Origin | Nerv Technology Inc. (D.B.A.) Fluidai Medical Aug 21, 2025 |
| K251647 — MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System | Dentsply Sirona, Inc. Aug 21, 2025 |
| K250784 — Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) | Shenzhen Yicai Health Technology Co., Ltd. Aug 21, 2025 |
| K251029 — Vista OS, Vista AI Scan, RTHawk | Vista AI, Inc. Aug 21, 2025 |
| K250923 — Fine Osteotomy | Bodycad Laboratories, Inc. Aug 21, 2025 |
| K251130 — Portable Oxygen Concentrator (JM-P50A) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Aug 21, 2025 |
| K251135 — Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts Aug 21, 2025 |
| K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | bioMerieux, Inc. Aug 21, 2025 |
| K251588 — LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) | Shenzhen Fittop Health Technology Co., Ltd. Aug 21, 2025 |
| K252356 — The Acumed Wrist Fixation System - 2.4mm Screws | Acumed, LLC Aug 21, 2025 |
| K252244 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid | Ever Global (Vietnam) Enterprise Corporation Aug 21, 2025 |
| K241152 — InSee | Tidal Medical Technologies, LLC Aug 21, 2025 |
| K250994 — ClearTip FNA and FNB Types | Finemedix Co., Ltd. Aug 21, 2025 |
| K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH Aug 20, 2025 |
| K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | Liofilchem S.R.L. Aug 20, 2025 |
| DEN250002 — Delphi-MD System | Quantalx Neuroscience, Ltd. Aug 20, 2025 |
| K250417 — Remanufactured EndoWrist Cobra Grasper (420190) | Rebotix Aug 20, 2025 |
| K252061 — Distal Xtremities System | TriMed, Inc. Aug 20, 2025 |
| K251590 — Methinks CTA Stroke | Methinks Software, S.L Aug 20, 2025 |