| 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 |
| K243179 — Sterilization Pouch and Roll | Yichang Xinxin Paper Products Co., Ltd. Jun 26, 2025 |
| K250519 — Lap.Ox Laparoscopic Tissue Oximeter | ViOptix, Inc. Jun 26, 2025 |
| K250967 — Sherlock | Open Implants, LLC Jun 26, 2025 |
| K251395 — The Rialto SI Fusion System | Medtronic Sofamor Danek USA, Inc. Jun 26, 2025 |
| K251694 — safety lancet | Tianjin Huahong Technology Co., Ltd. Jun 26, 2025 |
| K251632 — Optimas MAX System | InMode , Ltd. Jun 26, 2025 |
| K251613 — SwissGraft X | Geistlich Pharma AG Jun 26, 2025 |
| K251627 — BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) | Smith & Nephew, Inc. Jun 25, 2025 |
| K250747 — Globe® Pulsed Field System | Kardium, Inc. Jun 25, 2025 |
| K242845 — EGIS Biliary Double Bare Stent (BDB080405) | S&G Biotech, Inc. Jun 25, 2025 |
| K250774 — SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | PAJUNK GmbH Medizintechnologie Jun 25, 2025 |
| K251606 — Power Wheelchair (D26) | Anhui Jbh Medical Apparatus Co., Ltd. Jun 25, 2025 |
| K243184 — SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings Jun 25, 2025 |
| K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) | Fisher & Paykel Healthcare, Ltd. Jun 25, 2025 |
| K250302 — Flexible Partial Resin | Prismatik Dentalcraft, Inc. Jun 25, 2025 |
| K250921 — CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. Jun 25, 2025 |
| K251725 — ANAX OCT Spinal System | Cg Medtech Co., Ltd. Jun 25, 2025 |
| K250966 — CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Jun 25, 2025 |
| K251003 — X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. Jun 25, 2025 |
| K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. Jun 25, 2025 |
| K243112 — Curapuls 670 | Enraf-Nonius, B.V. Jun 25, 2025 |
| K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. Jun 25, 2025 |