| K251734 — ProVee Video Processing Unit (PV-003) | Proverum Limited Sep 24, 2025 |
| K252183 — Resitu Slider 09 (RESL09) | Resitu Medical AB Sep 24, 2025 |
| K252227 — Pounce(TM) Sheath | Surmodics,Inc. Sep 24, 2025 |
| K250045 — uWS-Angio Pro | Shanghai United Imaging Healthcare Co., Ltd. Sep 24, 2025 |
| K252703 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) | Boston Scientific Corporation Sep 24, 2025 |
| K251206 — Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. Sep 24, 2025 |
| K252680 — Celerity 20 HP Biological Indicator | STERIS Corporation Sep 24, 2025 |
| K251483 — SwiftSight-Brain | Airs Medical, Inc. Sep 23, 2025 |
| K253053 — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. Sep 23, 2025 |
| K250209 — Polyvinyl Alcohol Embolic Microspheres | Canyon Medical, Inc. Sep 23, 2025 |
| K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900) | Edwards Lifesciences, LLC Sep 23, 2025 |
| K251894 — Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. Sep 23, 2025 |
| DEN240080 — Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated Sep 23, 2025 |
| K252644 — PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | M/S. Meril Endo Surgery Private Limited. Sep 23, 2025 |
| K252043 — Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | Olympus Winter & Ibe GmbH Sep 23, 2025 |
| K251987 — Rapid Aortic Measurements | Ischemaview, Inc. Sep 23, 2025 |
| K252045 — Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. Sep 23, 2025 |
| K251973 — Luminance Red Cold Sore Device (TN1927G) | Luminance Medical Ventures, Inc. Sep 23, 2025 |
| K251140 — Zenflow Spring Scope | Zenflow, Inc. Sep 23, 2025 |
| K243645 — IC-Flow Imaging System 2.0 | Diagnostic Green GmbH Sep 22, 2025 |
| K250388 — ENDOFLATOR + | Karl Storz SE & CO. KG Sep 22, 2025 |
| K251743 — SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | Surgical Principals, Inc. Sep 22, 2025 |
| K252315 — Santreva-ATK Endovascular Revasculariztion Catheter | AngioSafe, Inc. Sep 22, 2025 |
| K250205 — Babio® Virus Transport Kit (Non-inactivating) | Jinan Babio Biotechnology Co., Ltd. Sep 22, 2025 |
| K252613 — Unscented menstrual three-piece applicator tampon | Unibeauty (Hubei) Technology Co., Ltd. Sep 19, 2025 |
| K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | Nakanishi, Inc. Sep 19, 2025 |
| K241868 — xR IVD | Tempus AI, Inc. Sep 19, 2025 |
| K243920 — Purema H Hemoconcentrator - Pediatric | Medica USA, Inc. Sep 19, 2025 |
| K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. Sep 19, 2025 |
| K252647 — Tapestry Biointegrative Implant | Embody, Inc. Sep 19, 2025 |
| K250777 — Sonicaid Team3 | Huntleigh Healthcare , Ltd. Sep 19, 2025 |
| DEN240067 — KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | Cytocell Limited Sep 19, 2025 |
| K252662 — UniBur | Nakanishi, Inc. Sep 19, 2025 |
| K251167 — uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. Sep 19, 2025 |
| K250450 — Coated hip implants | Medacta International S.A. Sep 19, 2025 |
| K242859 — VEGA | Ibramed Equipamentos Médicos Sep 19, 2025 |
| K244035 — Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. Sep 19, 2025 |
| K250128 — Single Use Suction-Evacuation Ureteral Access Sheath | Anhui Happiness Workshop Medical Instruments Co., Ltd. Sep 19, 2025 |
| K250953 — EQUIA LC ONE | GC America, Inc. Sep 19, 2025 |
| K251100 — IPGTFL-02 | Ipg Medical Corporation Sep 19, 2025 |
| K243990 — BondEase 2 Topical Skin Adhesive | Optmed, Inc. Sep 19, 2025 |
| K250408 — Alegria Flash ENA Screen | Zeus Scientific Sep 19, 2025 |
| K252657 — Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. Sep 19, 2025 |
| K252285 — Well-Root PT | Vericom Co., Ltd. Sep 19, 2025 |
| K250649 — Bunkerhill ECG-EF | BunkerHill Health Sep 19, 2025 |
| K251002 — Videa Dental AI | Videahealth, Inc. Sep 19, 2025 |
| K250883 — ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | Olympus Medical Systems Corporation Sep 18, 2025 |
| K251479 — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) | Mobarn Medical Devices, LLC Sep 18, 2025 |
| K251905 — Normatec Elite Hip | NormaTec Industries, LP Sep 18, 2025 |
| K251597 — InnerView System | Perimetrics, Inc. Sep 18, 2025 |