| K231952 — MEDILIGHT | Medicreations, LLC Sep 3, 2025 |
| K251575 — IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | Alphatec Spine Sep 3, 2025 |
| K251909 — NeurotriS (SX2500); NeurotriS (SX3800) | A-1 Engineering Sep 3, 2025 |
| K252454 — Kinos Total Ankle System | Restor3D Sep 3, 2025 |
| K252174 — AquaCast Mask | Blessing Cathay Corporation Sep 3, 2025 |
| K250765 — AViTA Arm Type Blood Pressure Monitor Cuff | Avita Corporation Sep 3, 2025 |
| K252446 — BruxZir® NOW | Prismatik Dentalcraft, Inc. Sep 3, 2025 |
| K252539 — Tempus Pixel | Arterys, Inc. Sep 3, 2025 |
| K251726 — SignalNED System (Model RE) | Forest Devices, Inc. Sep 3, 2025 |
| K250231 — Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) | Dongguan E-Test Technology Co., Ltd. Sep 3, 2025 |
| K251615 — Aerogen Pro-X1 Controller System | Aerogen, Ltd. Sep 2, 2025 |
| K251775 — RODIN Cement | Belport Company, Inc., Gingi-Pak Sep 2, 2025 |
| K242768 — Customized Abutment and Screw | Chengdu Besmile Medical Technology Co., Ltd. Sep 2, 2025 |
| K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) | Philips Medizin Systeme Böblingen GmbH Sep 2, 2025 |
| K251975 — Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component | Ignite Orthomotion Sep 2, 2025 |
| K251408 — OsteoSight Hip (v1) | Naitive Technologies, Ltd. Sep 2, 2025 |
| K250753 — VELMENI for DENTISTS (V4D) | Velmeni, Inc. Sep 2, 2025 |
| K252364 — Edwards eSheath Optima introducer set | Edwards Lifesciences Aug 29, 2025 |
| K251106 — Sonosite LX and Sonosite PX Ultrasound Systems | FUJIFILM Sonosite, Inc. Aug 29, 2025 |
| K251217 — SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. Aug 29, 2025 |
| K251026 — Regenesis EMS Chair | Trinity Medical Solutions Aug 29, 2025 |
| K250335 — IVA & AEON Cervical and Lumbar Cage System | K&J Consulting Aug 29, 2025 |
| K251718 — ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. Aug 29, 2025 |
| K252392 — Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. Aug 29, 2025 |
| K250771 — Primescan 2 | Dentsply Sirona, Inc. Aug 29, 2025 |
| K251108 — Erbe ESU Model VIO® 3n with Accessories | Erbe Elektromedizin GmbH Aug 29, 2025 |
| K251946 — G aenial Universal Injectable II | GC America, Inc. Aug 29, 2025 |
| K250285 — NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL | Raumedic AG Aug 29, 2025 |
| K250003 — GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology, Inc. Aug 29, 2025 |
| K250290 — SurgiTwin | Twinsight Aug 29, 2025 |
| K252380 — Invisalign System | Align Technology, Inc. Aug 29, 2025 |
| K251727 — GLAM LED Facial Mask (TB-2386F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. Aug 29, 2025 |
| K250874 — Sunrise | Sunrise SA Aug 29, 2025 |
| K251324 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Aug 29, 2025 |
| K251480 — PV01 PVDF Effort Sensor | Neurotronics, LLC Aug 29, 2025 |
| K250939 — SIRIUS Endoscope System (PR-SI-1230) | Precision Robotics (Hong Kong) Limited Aug 29, 2025 |
| K243799 — Fetal Pillow | CooperSurgical, Inc. Aug 29, 2025 |
| K243859 — PRAEVAorta®2 | Nurea Aug 29, 2025 |
| K251814 — EZ IV Administration Set | Epic Medical Pte. , Ltd. Aug 29, 2025 |
| K252019 — CurvaFix Low Profile System | Curvafix, Inc. Aug 29, 2025 |
| K251181 — Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) | Merit Medical Ireland, Ltd. Aug 29, 2025 |
| K243745 — FG Bone Graft B | Full Golden Biotech Corporation Aug 29, 2025 |
| K251429 — OTC 4-Channel Rechargeable TENS Unit | Changsha Anxiang Medical Technology Co., Ltd. Aug 28, 2025 |
| K251594 — truFlex | Syrma Johari Medtech Limited Aug 28, 2025 |
| K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. Aug 28, 2025 |
| K250148 — Medical Gas Analyzer (AG200) | Prior Care Science Technology, Ltd. Aug 28, 2025 |
| K243767 — SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Aug 28, 2025 |
| K251484 — CT:VQ | 4Dmedical Limited Aug 28, 2025 |
| K252030 — RadiForce GX570; RadiForce GX570-AR | Eizo Corporation Aug 28, 2025 |
| K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL | Thermo Fisher Scientific Aug 28, 2025 |