| K243062 — BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) | Becton Dickinson Jun 20, 2025 |
| K251240 — Branchor X Balloon Guide Catheter | Asahi Intecc Co., Ltd. Jun 20, 2025 |
| K243589 — PAL Sterilization Case | Microaire Surgical Instruments, LLC Jun 20, 2025 |
| K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. | Thermo Fisher Scientific Jun 20, 2025 |
| K251567 — NovoSorb BTM | Polynovo Biomaterials Pty, Ltd. Jun 20, 2025 |
| K242985 — CollOvine Wound Dressing | Ovigenex, LLC Jun 20, 2025 |
| K250877 — TMINI Miniature Robotic System | THINK Surgical, Inc. Jun 20, 2025 |
| K250732 — Disposable Endoscopy Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. Jun 20, 2025 |
| K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | Shenzhen Medke Technology Co., Ltd. Jun 20, 2025 |
| K243120 — HybridAPC probe | Erbe Elektromedizin GmbH Jun 20, 2025 |
| K250566 — EsCem RMGI | Spident Co., Ltd. Jun 20, 2025 |
| K250151 — Us2.ca | Eko.Ai Pte Ltd. D/B/A Us2.Ai Jun 20, 2025 |
| K251248 — ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02) | Jinhua Qidian Vehicle Co., Ltd. Jun 20, 2025 |
| K250880 — LED LIGHT MASK (A093) | Foshan Guangyu Weilai Medical Equipment Co., Ltd. Jun 20, 2025 |
| K250037 — Incompass Total Ankle System | Wright Medical Technology, Inc. (Stryker) Jun 20, 2025 |
| K251560 — FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. Jun 20, 2025 |
| K243978 — LED Facial Mask | Shenzhen Sunsred Technology Co.,Ltd Jun 20, 2025 |
| K251258 — MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | Medtronic, Inc. Jun 20, 2025 |
| K250515 — EpiMonitor | Empatica S.R.L. Jun 19, 2025 |
| K242944 — Leone Orthodontic Implant TAD (Temporary Anchorage Device) | Leone S.P.A. Jun 19, 2025 |
| K251235 — Electrosurgical Pads | Baisheng Medical Co., Ltd. Jun 19, 2025 |
| K243366 — DRX9000C-SL Cervical Spinal Decompression System | Excite Medical Of Tampa Bay, LLC Jun 18, 2025 |
| K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45) | Shanghai Saints Sages Surgical Co., Ltd. Jun 18, 2025 |
| K242224 — Happy Health Home Sleep Test | Happy Health, Inc. Jun 18, 2025 |
| K242922 — Extracorporeal Shock Wave Lithotripter (U200) | Shenzhen Wikkon Precision Technologies Co., Ltd. Jun 18, 2025 |
| K243253 — 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | Esaote, S.P.A. Jun 18, 2025 |
| K243014 — EyeQ nanoECP | Eyeq, Inc. Jun 18, 2025 |
| K243672 — CardIQ Suite | GE Medical Systems SCS Jun 18, 2025 |
| K250845 — Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. Jun 18, 2025 |
| K250908 — Virata Spinal Fixation System | SeaSpine Orthopedics Corporation Jun 18, 2025 |
| K250872 — Bioline Dental Implant System | Bioline Dental Implant Systems, Ltd. Jun 18, 2025 |
| K242917 — Enteral Drainage System, Enteral Medicine straw | HMC Premedical S.P.A. Jun 18, 2025 |
| K251530 — CONMED Argo Knotless® Anchor | Conmed Corporation Jun 18, 2025 |
| K251296 — The Acumed Wrist Fixation System | Acumed, LLC Jun 18, 2025 |
| K250492 — FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC Jun 18, 2025 |
| K243102 — Mobility Scooter (JT10) | Jiangxi Jiangte Electric Vehicle Co., Ltd. Jun 18, 2025 |
| K243172 — Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles | O&M Halyard, Inc. Jun 18, 2025 |
| K251253 — PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port | Bard Access Systems, Inc. Jun 18, 2025 |
| K251634 — LZI Fentanyl III Enzyme Immunoassay | Lin-Zhi International, Inc. Jun 18, 2025 |
| K242933 — SPINEART Navigation Instrument System | Spineart SA Jun 18, 2025 |
| K250886 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC Jun 18, 2025 |
| K250082 — Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. Jun 18, 2025 |
| K243039 — Ureteral Stents (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. Jun 18, 2025 |
| K243583 — F&P Nova Nasal Mask | Fisher & Paykel Healthcare Limited Jun 18, 2025 |
| K250219 — Dorado PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. Jun 17, 2025 |
| K243133 — Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | Kl-Kepong Rubber Products Sdn. Bhd. Jun 17, 2025 |
| DEN240066 — COAPTIUM Connect with TISSIUM LIGHT | Tissium SA Jun 17, 2025 |
| K251017 — CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Jun 17, 2025 |
| K250997 — Integrity Implant | Anika Therapeutics, Inc. Jun 17, 2025 |
| K243880 — Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | Wuxi Hisky Medical Technologies Co., Ltd. Jun 17, 2025 |