| K252517 — Manual Wheelchair (SYIV100A008) | Ningbo Shenyu Medical Equipment Co.,Ltd Oct 3, 2025 |
| K251859 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation Oct 3, 2025 |
| K252820 — PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) | Internacional Farmacéutica S.A DE C.V Oct 3, 2025 |
| K252806 — Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) | Shanghai AnQing Medical Instrument Co., Ltd. Oct 3, 2025 |
| K250662 — Bunkerhill MAC | BunkerHill Health Oct 3, 2025 |
| K242946 — HESTIA (L200-A) | Senbitec Co., Ltd. Oct 3, 2025 |
| K251639 — xvision Spine system | Augmedics, Ltd. Oct 3, 2025 |
| K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Bioscience, Inc. Oct 3, 2025 |
| K251646 — extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices Oct 3, 2025 |
| K252129 — AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. Oct 3, 2025 |
| K252769 — Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) | Shenzhen Finicare Co., Ltd. Oct 2, 2025 |
| K252440 — EasyTeleMed (2.0.2) | Ingeniars S.R.L. Oct 2, 2025 |
| K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | Liofilchem S.R.L. Oct 2, 2025 |
| K250551 — 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) | Shenzhen Sophway Technology Co., Ltd. Oct 2, 2025 |
| K251124 — G-Bond Universal | GC America, Inc. Oct 2, 2025 |
| K250860 — BreatheBand® (Model 1000) | Exemplar Medical, LLC Oct 2, 2025 |
| K251442 — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | Ningbo Tianyi Medical Appliance Co., Ltd. Oct 2, 2025 |
| K250766 — LungQ 4 | Thirona BV Oct 2, 2025 |
| K252758 — Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. Oct 2, 2025 |
| K250523 — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) | Simergent, LLC Oct 2, 2025 |
| K251215 — Philips IntelliSpace Cardiovascular | Philips Medical Systems Nederland B.V. Oct 2, 2025 |
| K252059 — CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | Artivion, Inc. Oct 2, 2025 |
| K243152 — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | Applied Medical Resources Corp. Oct 2, 2025 |
| K251398 — IPL Hair Removal Device (IPL-001, IPL-002) | Shenzhen Enmind Technology Co., Ltd. Oct 2, 2025 |
| K252096 — Light Therapy Decollete Mask (1019135) | Merchsource, LLC Oct 1, 2025 |
| K252447 — Picosecond laser device (BMPS4) | Hebei Newangie Technology Co., Ltd. Oct 1, 2025 |
| K250026 — Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) | Wuxi Hisky Medical Technologies Co., Ltd. Oct 1, 2025 |
| K251501 — Visby Medical Men's Sexual Health Test | Visby Medical, Inc. Oct 1, 2025 |
| K251767 — Vena MicroAngioscope System | Vena Medical Holdings Corp Oct 1, 2025 |
| K250083 — PRO-DOSE System | Nu-Rise, SA Oct 1, 2025 |
| K252804 — Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, | Shenzhen Ulike Smart Electronics Co., Ltd. Oct 1, 2025 |
| K251899 — E Blator | New Deantronics Taiwan , Ltd. Oct 1, 2025 |
| K251825 — Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) | Shenzhen Ulike Smart Electronics Co., Ltd. Oct 1, 2025 |
| K250767 — Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics Oct 1, 2025 |
| K252106 — External Fixation Mini Rail System | Paragon 28, Inc. Sep 30, 2025 |
| K251669 — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter | Shanghai Draeger Medical Instrument Co., Ltd. Sep 30, 2025 |
| K252085 — Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | Wright Medical Technology, Inc. (Stryker Corporation) Sep 30, 2025 |
| K251690 — Arthrex SpeedFLEX Implant | Arthrex, Inc. Sep 30, 2025 |
| K250050 — miDiagnostics HSV-1&2 CSF Test | Midiagnostics NV Sep 30, 2025 |
| K252072 — Francisella tularensis Real-time PCR assay | Centers For Disease Control And Prevention Sep 30, 2025 |
| K251799 — Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) | Jiangsu Bangbang Intelligent Technology Co., Ltd. Sep 30, 2025 |
| K243270 — TigerConnect Alarm Management | Tigerconnect Sep 30, 2025 |
| K250331 — Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. Sep 30, 2025 |
| K251197 — Dexter L6 System | Distalmotion SA Sep 30, 2025 |
| K252722 — Biopsy Forceps | Fehling Instruments GmbH Sep 30, 2025 |
| K250023 — SMART PCFD | Disior, Ltd. Sep 29, 2025 |
| K252594 — UltraGuideCTR® image guided soft tissue release system | Sonex Health Sep 29, 2025 |
| K252054 — SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. Sep 29, 2025 |
| K243833 — Portable oxygen concentrator (JAY-1000P) | Longfian Scitech Co., Ltd. Sep 29, 2025 |
| K251104 — SureTome SW Sphincterotome with DomeTip | Wilson-Cook Medical Sep 29, 2025 |