| K250329 — GeniPhys Collymer Self-Assembling Scaffold | Geniphys, Inc. Jun 25, 2025 |
| K251362 — PediFlex Flexible Nail System | OrthoPediatrics Corp. Jun 24, 2025 |
| K251358 — Bridge Plus Occlusion Balloon (590-002) | Philips Image Guided Therapy Devices Jun 24, 2025 |
| K243009 — MIST IC | Imagine Milling Technologies, LLC Jun 24, 2025 |
| K250268 — HyperSnap Surgical System (HSS) | Hypervision Surgical Jun 24, 2025 |
| K251648 — GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. Jun 24, 2025 |
| K250326 — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) | Spectrum Medical S.R.L. Jun 24, 2025 |
| K251644 — ProAM ALIF System | Pro Surgical, Inc. Jun 24, 2025 |
| K243142 — Cranial 4Pi Immobilization | Brainlab AG Jun 23, 2025 |
| K250885 — Ceftobiprole BPR 5 µg Disc | Liofilchem, Inc. Jun 23, 2025 |
| K250143 — Digital Prism Correction Feature (DPCF) | Apple, Inc. Jun 23, 2025 |
| K250470 — Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) | Shenzhen AOJ Medical Technology Co., Ltd. Jun 23, 2025 |
| K242924 — OPXION Optical Skin Viewer (OPXSV1-01F) | Opxion Technology, Inc. Jun 23, 2025 |
| K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) | Olympus Medical Systems Corp. Jun 23, 2025 |
| K251271 — TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. Jun 23, 2025 |
| K243339 — WiTOF | Idmed Jun 23, 2025 |
| K251570 — Hippocampe Marathon and Trail | Vipamat Sarl Jun 23, 2025 |
| K243053 — Navient Image Guided Navigation System (ENT) (955-NC-NC) | Claronav Jun 20, 2025 |
| K250968 — PathPresenter Clinical Viewer | Pathpresenter Corporation Jun 20, 2025 |
| K242964 — Celsi Warmer | Hadleigh Health Technologies Jun 20, 2025 |
| K251224 — Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. Jun 20, 2025 |
| K242981 — Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. Jun 20, 2025 |
| K243398 — CT Scanner TSX-501R/1 V11.1 | Canon Medical Systems Corporation Jun 20, 2025 |
| K251114 — FloPatch FP120 | Flosonics Medical Jun 20, 2025 |
| K243168 — Alinity i Rubella IgG | Abbott Laboratories Jun 20, 2025 |
| K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters | Sophysa Jun 20, 2025 |
| K242911 — Medconn Glycated Hemoglobin Test system | Shanghai Medconn Medical Technology Co., Ltd. Jun 20, 2025 |
| K250583 — AdheResp Smart Breath-actuated Mesh Nebulizer | Hcmed Innovations Co., Ltd. Jun 20, 2025 |
| 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 |