| K250096 — Felix NeuroAI System | Fasikl Incorporated Jul 1, 2025 |
| K251933 — SnugFit ASA Extension | Medacta International S.A. Jul 1, 2025 |
| K250204 — Endoscopic Camera System | Shenzhen Sophway Technology Co., Ltd. Jul 1, 2025 |
| K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | Thermo Fisher Scientific Jun 30, 2025 |
| K250670 — EchoConfidence (USA) | Mycardium AI Limited Jun 30, 2025 |
| K250987 — aprevo® posterior/transforaminal lumbar interbody fusion device | Carlsmed, Inc. Jun 30, 2025 |
| K250484 — PIUR tUS inside | Piur Imaging GmbH Jun 30, 2025 |
| K243647 — Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation Jun 30, 2025 |
| K250022 — HeroTracker Sense | Voluntis Jun 30, 2025 |
| K251000 — Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) | Shenzhen Chuangtong Yigou Technology Co., Ltd. Jun 30, 2025 |
| K251088 — Otsuka Digital Feedback Device | Otsuka America Pharmaceutical, Inc. Jun 30, 2025 |
| K250972 — Primum Hydrophilic Guiding Catheter | Pendracare Jun 29, 2025 |
| K250585 — LumenaTM Ureteral Access Sheath | Cathegenix (Xiamen) Co., Ltd. Jun 27, 2025 |
| K243130 — Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co., Ltd., Jun 27, 2025 |
| K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Sorin Group Italia S.R.L. Jun 27, 2025 |
| K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4You AG Jun 27, 2025 |
| K251210 — Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications Jun 27, 2025 |
| K243144 — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. Jun 27, 2025 |
| K243682 — SonoPlex STIM; SonoPlex II | PAJUNK GmbH Medizintechnologie Jun 27, 2025 |
| K251431 — FIX-C PEEK ACIF SA System | Jeil Medical Corporation Jun 27, 2025 |
| K250648 — Philips iCT CT system | Philips Medical Systems Nederland B.V. Jun 27, 2025 |
| K243077 — Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) Jun 27, 2025 |
| K250984 — Maestro System (REF100) | Moon Surgical Jun 27, 2025 |
| K243187 — Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical Jun 27, 2025 |
| K251660 — T3 Pro Implants ZimVie Packaging System | Biomet 3I, LLC Jun 27, 2025 |
| K250828 — CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC Jun 27, 2025 |
| K251654 — BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. Jun 27, 2025 |
| K243388 — Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. Jun 27, 2025 |
| K243190 — USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG Jun 27, 2025 |
| K251642 — Dental CBCT X-ray System | Yian Medical Technology (Haining) Co., Ltd. Jun 27, 2025 |
| K243900 — eMotus Respiratory Motion Management System | Empnia, Inc. Jun 27, 2025 |
| K243816 — Testa TP Pivoting Spacer System | Spine Wave, Inc. Jun 27, 2025 |
| K242988 — Genostis Osteosynthesis System | Genostis AF Jun 27, 2025 |
| K251329 — Diode laser device (RF3120-BI) | Risu Medical Technology Co., Ltd. Jun 27, 2025 |
| K250522 — Multi4 System | Multi4 Medical AB Jun 27, 2025 |
| K250310 — VIKING Fixed Curve Diagnostic Catheter | Boston Scientific Corporation Jun 27, 2025 |
| K251116 — Luja Coudé | Coloplast Corp. Jun 27, 2025 |
| K243183 — RTMsense Respiratory Monitoring System | Rtm Vital Signs, LLC Jun 27, 2025 |
| K243175 — Disposable Intermittent Catheter (TPU Catheter) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. Jun 26, 2025 |
| K250940 — Atmo Gas Capsule System | Atmo Biosciences, Ltd. Jun 26, 2025 |
| K250929 — TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) | TriMed, Inc. Jun 26, 2025 |
| K251728 — Velacur One (LI-1100) | Sonic Incytes Medical Corp Jun 26, 2025 |
| K243391 — AISight Dx | PathAI, Inc. Jun 26, 2025 |
| K243636 — Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC Jun 26, 2025 |
| K242846 — Doppler FHR Detector (BF-500D+, BF-560) | Shenzhen Bestman Instrument Co., Ltd. Jun 26, 2025 |
| K250956 — HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics Jun 26, 2025 |
| K243275 — Equinoxe® Scapula Fracture System | Exactech, Inc. Jun 26, 2025 |
| K243079 — NeuroTrac® MyoPlus Pro (MYO120U) | Verity Medical , Ltd. Jun 26, 2025 |
| K251717 — Freedom® Total Knee System Titanium Tibial Base Plate | Maxx Orthopedics, Inc. Jun 26, 2025 |
| K250548 — Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) | Joytech Healthcare Co. , Ltd. Jun 26, 2025 |