| K231976 — StealthStation Cranial Software, v3.1.5 (9735585) | Medtronic Navigation, Inc. Oct 19, 2023 |
| K232897 — Arthrex Small External Fixation System | Arthrex, Inc. Oct 18, 2023 |
| K230199 — Byte Aligner System | Dentsply Sirona, Inc. Oct 18, 2023 |
| K231225 — EConsole1 | DRTECH Corporation Oct 18, 2023 |
| K230951 — Terumo Injection Filter Needle (NF-3013RBKE05M) | Terumo Europe N.V. Oct 18, 2023 |
| K231395 — INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. Oct 18, 2023 |
| K231781 — OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. Oct 18, 2023 |
| K232123 — MectaLIF Anterior Lag Extension | Medacta International S.A. Oct 18, 2023 |
| K231826 — Omnipod 5 ACE Pump | Insulet Corporation Oct 18, 2023 |
| K231907 — Medline Safety Insulin and TB Syringes | Medline Industries, LP Oct 18, 2023 |
| K232924 — T-Line® Hernia Mesh | Deep Blue Medical Advances, Inc. Oct 18, 2023 |
| K232524 — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. Oct 18, 2023 |
| K231824 — SmartBolus Calculator | Insulet Corporation Oct 18, 2023 |
| K230702 — Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) | Qingdao Kingon Medical Science And Technology Co., Ltd. Oct 18, 2023 |
| K231105 — Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) | Shanghai AnQing Medical Instrument Co., Ltd. Oct 17, 2023 |
| K223911 — Lumen 155-SF | Intricon Corporation Oct 17, 2023 |
| K232903 — Legend X Platform | Pollogen, Ltd. Oct 17, 2023 |
| K232878 — TransLoc 3D | Foundation Fusion Solutions, LLC (Dba Cornerloc) Oct 17, 2023 |
| K222214 — ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | Thi Total Healthcare Innovation GmbH Oct 17, 2023 |
| K231477 — Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. Oct 17, 2023 |
| K231899 — HAtetracell-C Titanium Cervical IBF System | Innovasis, Inc. Oct 17, 2023 |
| K232151 — Dynamic TiBase | Talladium España, SL Oct 17, 2023 |
| K232089 — SOZO Pro | ImpediMed Limited Oct 17, 2023 |
| K231725 — Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) | Hunan Endoso Life Technology Co., Ltd. Oct 16, 2023 |
| K232118 — ANDORATE® Valve Kit | Ga Health Company Limited Oct 16, 2023 |
| K232020 — Iontophoresis Electrodes | Top-Rank Health Care Co., Ltd. Oct 16, 2023 |
| K230570 — Willow Generation 3 Breast Pump | Willow Innovations, Inc. Oct 16, 2023 |
| K230249 — Ikshana | Immersivetouch Oct 16, 2023 |
| K230104 — Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL | Anthogyr Oct 16, 2023 |
| K232128 — Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | Shenzhen AOJ Medical Technology Co., Ltd. Oct 14, 2023 |
| K231672 — S1 | Medpark Co., Ltd. Oct 13, 2023 |
| K230741 — Macro & Micro-Test HCG Pregnancy Test Midstream | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. Oct 13, 2023 |
| K232481 — RIGEL 3DR Anterior Cervical Corpectomy System | MiRus, LLC Oct 13, 2023 |
| K232437 — Paragon 8F Balloon Guide Catheter | Wallaby Medical Oct 13, 2023 |
| K232822 — Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) | Gbs Commonwealth Co., Ltd. Oct 13, 2023 |
| K231744 — VyLink Spinal Screw System | Vy Spine, LLC Oct 13, 2023 |
| K223697 — MRI compatibility for existing BioHorizons dental implants and abutments | BioHorizons Implant Systems, Inc. Oct 13, 2023 |
| K230125 — Neuroblade System | Clearmind Biomedical Oct 13, 2023 |
| K230495 — Serena Sleep Night Guard | Meris Investment Group Oct 13, 2023 |
| K223863 — BONHAWA Respiratory Humidifier | Telesair, Inc. Oct 13, 2023 |
| K211676 — Motiva Flora SmoothSilk Tissue Expander | Motiva USA, LLC Oct 13, 2023 |
| K232504 — Calibrate CCX Interbody System | Alphatec Spine, Inc. Oct 13, 2023 |
| K232429 — Titan Dental Design | Clearadvance, LLC Oct 13, 2023 |
| K231642 — Veuron-Brain-pAb3 | Heuron Co., Ltd. Oct 13, 2023 |
| K230440 — Xpert® Xpress CoV-2 plus | Cepheid® Oct 13, 2023 |
| K230370 — SpotLight/SpotLight Duo (with DLIR option) | Arineta , Ltd. Oct 13, 2023 |
| K222143 — APIS (R), VERIS (TM) | Sweetbio, Inc. Oct 13, 2023 |
| K231495 — The Evolve System with the Transform Applicator | InMode , Ltd. Oct 13, 2023 |
| K231708 — Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) | Axogen Corporation Oct 12, 2023 |
| K231486 — Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC Oct 12, 2023 |