| 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 |
| K252350 — da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. Aug 28, 2025 |
| K252437 — JAZZ Spinal System | Implanet Aug 28, 2025 |
| K250788 — Definium Tempo Select | Ge Hualun Medical Systems Co. , Ltd. Aug 28, 2025 |
| K243901 — SmartPilot YpsoMate NS-A2.25 | Ypsomed AG Aug 28, 2025 |
| K252411 — JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie Aug 28, 2025 |
| K252505 — Powder-Free Vinyl Exam Gloves, clear | Basic Medical Technology, Inc. Aug 28, 2025 |
| K252057 — Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System | Imperative Care, Inc. Aug 28, 2025 |
| K252383 — Somfit D | Compumedics Limited Aug 28, 2025 |
| K252118 — CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. Aug 27, 2025 |
| K250947 — VistaSoft 4.0 and VisionX 4.0 | Durr Dental SE Aug 27, 2025 |
| K243166 — Dermalage | Infection Elimination Solutions, LLC Aug 27, 2025 |
| K251716 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology, Inc. Aug 27, 2025 |
| K241766 — QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV Aug 27, 2025 |
| K243774 — ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations Aug 27, 2025 |
| K251382 — Phoenix Sinus Tarsi Stent System | Astra Orthomed, Inc. Aug 27, 2025 |
| K251415 — Additively Manufactured Aligner Resin | Aidite (Qinhuangdao) Technology Co., Ltd. Aug 27, 2025 |
| K252419 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical, Inc. Aug 27, 2025 |
| K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini | QIAGEN GmbH Aug 27, 2025 |
| K243687 — Vital Signs | Oxehealth Limited Aug 27, 2025 |
| K251068 — KnoxFog Anti-fogging Device | Uv One Hygienics, Inc. Aug 27, 2025 |
| K251752 — Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) | Shanghai AnQing Medical Instrument Co., Ltd. Aug 27, 2025 |
| K241882 — Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. Aug 27, 2025 |