| K232274 — IPL hair removal device | Lumenessa Corp Sep 28, 2023 |
| K231188 — ALIGN Radial Head System | Skeletal Dynamics, Inc. Sep 28, 2023 |
| K232275 — Invictus® Spinal Fixation System | Alphatec Spine, Inc. Sep 27, 2023 |
| K231538 — FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., Sep 27, 2023 |
| K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | Cepheid Sep 27, 2023 |
| K230563 — EVOLUTION® Hinge Knee System | Microport Orthopedics, Inc. Sep 27, 2023 |
| K232668 — Cove Strip, OsteoCove Strip | SeaSpine Orthopedics Corporation Sep 27, 2023 |
| K214117 — Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer | Abbott Diagnostics Technologies AS Sep 27, 2023 |
| K231076 — VariLift®-C Interbody Fusion System | Wenzel Spine, Inc. Sep 27, 2023 |
| K232260 — Thinline Sheath Introducer | Inneuroco, Inc. Sep 27, 2023 |
| K232596 — EndoGI S-Path Biliary Stent System | Endogi Medical, Ltd. Sep 27, 2023 |
| K231108 — Talon Transseptal Sheath | Inari Medical, Inc. Sep 27, 2023 |
| K232609 — Micro Ace Advanced Micro Access System | Merit Medical Systems, Inc. Sep 27, 2023 |
| K232167 — VySpan PCT System | Vy Spine, LLC Sep 27, 2023 |
| K232255 — EZSensor XHD | Qpix Solutions, Inc. Sep 27, 2023 |
| K232616 — Volta AF-Xplorer | Volta Medical Sep 27, 2023 |
| K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) | Hantech Medical Device Co., Ltd. Sep 27, 2023 |
| K230925 — Disposable Injection Needle AF series | Alton (Shanghai) Medical Instruments Co., Ltd. Sep 27, 2023 |
| K231007 — CEDIA Heroin Metabolite (6-AM) Assay | Microgenics Corporation Sep 27, 2023 |
| K230884 — AVVIGO'+ Multi-Modality Guidance System | Boston Scientific Corporation Sep 26, 2023 |
| K223496 — Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems | Prismatik Dentalcraft, Inc. Sep 26, 2023 |
| K232233 — Invisalign System with Mandibular Advancement Featuring Occlusal Blocks | Align Technology, Inc. Sep 26, 2023 |
| K231971 — DEKA PHYSIQ 360 | El.En S.P.A. Sep 26, 2023 |
| K213517 — Access Thyroglobulin Antibody II | Beckman Coulter, Inc. Sep 26, 2023 |
| K232336 — ES Series V2 | E-Scopics Sep 26, 2023 |
| DEN220026 — VasQ | Laminate Medical Technologies , Ltd. Sep 26, 2023 |
| K230252 — OFIX MIS App | Orthofix US, LLC Sep 26, 2023 |
| K220396 — EasyStat 300 | Medica Corporation Sep 26, 2023 |
| K230513 — Arthrex Univers Apex OptiFit Humeral Stem | Arthrex, Inc. Sep 26, 2023 |
| K232617 — ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Sep 26, 2023 |
| K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad Sep 26, 2023 |
| K221052 — Self-Fitting hearing aids | Huizhou Jinghao Medical Technology Co., Ltd. Sep 25, 2023 |
| K230825 — Smileyscope System (Therapy Mode) | Smileyscope Holding, Inc. Sep 25, 2023 |
| K231928 — EFAI RTSUITE CT HCAP-Segmentation System | Ever Fortune.Ai, Co., Ltd. Sep 25, 2023 |
| K231888 — BD Texium Needle-Free Syringe | Care Fusion Sep 25, 2023 |
| K232097 — IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. Sep 25, 2023 |
| K230778 — EndoCore | Praxis Medical, LLC Sep 25, 2023 |
| K231739 — Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. Sep 25, 2023 |
| K223933 — Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | Exactech, Inc. Sep 25, 2023 |
| K231891 — Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | Coloplast Sep 25, 2023 |
| K231977 — PEACH 2, PEACH 2 Duo, PEACH 2 go | Foreo, Inc. Sep 25, 2023 |
| K230857 — TiLink-P SI Joint Fusion System | SurGenTec, LLC Sep 25, 2023 |
| K230184 — Holter ECG and ABP System | Edan Instruments, Inc. Sep 25, 2023 |
| K220265 — ADVIA Centaur® NT-proBNPII (PBNPII) | Siemens Healthcare Diagnostics, Inc. Sep 24, 2023 |
| K223919 — B.Light Clear Evo and B.Light Restore Evo | Bemer Int AG Sep 23, 2023 |
| K222778 — Osstem Implant System | Osstem Implant Co., Ltd. Sep 23, 2023 |
| K231767 — Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. Sep 22, 2023 |
| K232571 — CATHTONG II PICC Catheter | L&Z Us, Inc. Sep 22, 2023 |
| K232594 — CATHTONG II PICC Catheter | L&Z Us, Inc. Sep 22, 2023 |
| K232193 — Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) | Yurob Rehabilitation Medical Co., Ltd. Sep 22, 2023 |