| K231887 — ARIX Ankle Distal Tibia System | Jeil Medical Corporation Dec 14, 2023 |
| K233227 — VELYS Robotic-Assisted Solution | Depuy Ireland UC Dec 14, 2023 |
| K232401 — Disposable Veress Needles | Hangzhou Kangji Medical Instrument Co., Ltd. Dec 14, 2023 |
| K233648 — Millipede 088 Access Catheter | Perfuze, Ltd. Dec 14, 2023 |
| K233647 — VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. Dec 14, 2023 |
| K232455 — SofWave System | Sofwave Medical, Ltd. Dec 14, 2023 |
| K233594 — Genesys Spine 3DP AIS-C II Cervical Interbody System | Genesys Spine Dec 13, 2023 |
| K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx | Hangzhou AllTest Biotech Co., Ltd. Dec 13, 2023 |
| K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation Dec 13, 2023 |
| K231039 — CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. Dec 13, 2023 |
| K231614 — MiroTract Wound Matrix | Reprise Biomedical, Inc. Dec 13, 2023 |
| K230964 — Power Wheelchair (N5909) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Dec 13, 2023 |
| K231803 — Neodent Implant System - Zirconia Implant System | JJGC Indústria E Comércio De Materiais Dentários S.A. Dec 13, 2023 |
| K232877 — FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C Stand Alone System | K&J Consulting Corporation Dec 13, 2023 |
| K230852 — HemosIL Chromogenic Factor IX | Instrumentation Laboratory Company Dec 13, 2023 |
| K231870 — CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | Ge Medical Systems Information Technologies, Inc. Dec 13, 2023 |
| K233688 — Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation Dec 13, 2023 |
| K232680 — fMRI Hardware System | Nordicneurolab AS Dec 13, 2023 |
| K232572 — Kalitec Navigated Instrument System | Kalitec Direct, LLC Doing Business AS Kalitec Medical Dec 13, 2023 |
| K232659 — Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Guangzhou Decheng Biotechnology Co., Ltd. Dec 13, 2023 |
| K231337 — EndeavorRx | Akili Interactive Labs, Inc. Dec 13, 2023 |
| K232652 — Anatomical Plating System (various) | Tyber Medical, LLC Dec 13, 2023 |
| K233811 — DT Controlled Phototherapy Equipment | Daavlin Distributing Co. Dec 13, 2023 |
| K232231 — QP-Brain® | Quibim S.L. Dec 13, 2023 |
| K232063 — SaliPen | Saliwell , Ltd. Dec 13, 2023 |
| K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH Dec 13, 2023 |
| K233621 — NeuroStar Advanced Therapy System (Version 3.8) | Neuronetics Dec 13, 2023 |
| K232237 — Tyto Insights for Wheeze Detection | Tyto Care , Ltd. Dec 13, 2023 |
| K232077 — Atalante X | Wandercraft SAS Dec 13, 2023 |
| K232863 — Radiant Renewal Skincare Wand (HD-15, HD-15A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Dec 13, 2023 |
| K230742 — ACCLARENT AERA Eustachian Tube Dilation System | Acclarent, Inc. Dec 13, 2023 |
| K232947 — SIRA RFA Electrosurgical Device | Innoblative Designs, Inc. Dec 12, 2023 |
| K233646 — Intri24 Introducer Sheath (52-101) | Inari Medical, Inc. Dec 12, 2023 |
| K233645 — StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection | Boston Scientific Corporation - Dec 12, 2023 |
| K233037 — Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Device Co., Ltd. Dec 12, 2023 |
| K230872 — Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System | Shanghai Sanyou Medical Co, Ltd. Dec 12, 2023 |
| K233684 — TriALTIS Spine System | Medos International SARL Dec 12, 2023 |
| K233634 — TeleScan | Bb Imaging Dec 12, 2023 |
| DEN230027 — NaviCam ProScan | Ankon Technologies Co., Ltd. Dec 12, 2023 |
| K233222 — Aygün Sterilization Container Systems | Aygun Surgical Instruments Co., Inc. Dec 12, 2023 |
| K232451 — Insulia Bolus Companion | Voluntis Sa. Dec 12, 2023 |
| K233455 — ARx MIS Spinal Screw System | Life Spine, Inc. Dec 12, 2023 |
| K231669 — Ziehm Solo FD | Ziehm Imaging GmbH Dec 12, 2023 |
| K232425 — Signature ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) Dec 12, 2023 |
| K232290 — INTELLIO SHIFT System | ArthroCare Corporation Dec 11, 2023 |
| K232797 — Hygenix | Shenzhen Hygenix Industrial Co., Ltd. Dec 11, 2023 |
| K232303 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | Depuy Ireland UC Dec 11, 2023 |
| K232985 — 24HR513C | Lg Electronics.Inc Dec 11, 2023 |
| K232096 — Transpara Density 1.0.0 | Screenpoint Medical B.V. Dec 11, 2023 |
| K233693 — Nio Color 8MP (MDNC-8132) | Barco N.V. Dec 11, 2023 |