| 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 |
| K243618 — EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | Bridge TO Life Jun 17, 2025 |
| K243666 — uOmniscan | Shanghai United Imaging Healthcare Co., Ltd. Jun 17, 2025 |
| DEN240038 — Oxiplex® | Fziomed, Inc. Jun 17, 2025 |
| K250665 — SKR 3000 | Konica Minolta, Inc. Jun 17, 2025 |
| K243561 — Nano-Check Influenza+COVID-19 Dual Test | Nano-Ditech Corporation Jun 17, 2025 |
| K243003 — VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. Jun 17, 2025 |
| K250440 — RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | Brainlab AG Jun 17, 2025 |
| K250436 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. Jun 16, 2025 |
| K243011 — Silicone Urethral Catheter (Silicone Urethral Catheter) | Guangdong Ecan Medical Co., Ltd. Jun 16, 2025 |
| K250443 — MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | Siemens Healthcare GmbH Jun 16, 2025 |
| K250685 — Methinks NCCT Stroke | Methinks Software, S.L Jun 16, 2025 |
| K250900 — EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. Jun 16, 2025 |
| K251617 — X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. Jun 16, 2025 |
| K242870 — Access hsTnI | Beckman Coulter, Inc. Jun 16, 2025 |
| K244012 — Mosaic (V1.0.1) | Navier Medical Jun 16, 2025 |
| K242978 — Geo Abutment | Geomedi Co,., Ltd. Jun 16, 2025 |
| K243872 — BD Veritor System for SARS-CoV-2 | Becton, Dickinson And Company Jun 16, 2025 |
| K243036 — IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29) | Bestway Plastic And Metal Products , Ltd. Jun 15, 2025 |
| K240795 — Withings ECG App | Withings Jun 15, 2025 |
| K242863 — Bioptimal Bipolar Pacing Catheter | Bioptimal International Pte. , Ltd. Jun 15, 2025 |
| K242852 — ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) | Inomed Medizintechnik GmbH Jun 13, 2025 |
| K250075 — Medtronic Stedi Extra Support Guidewire | Medtronic, Inc. Jun 13, 2025 |