| K233182 — Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) | Zibo Kaiyue Mould Technology Co., Ltd. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230751 — EW10-EC02 Endoscopy Support Program | Fujifilm Corporation Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232598 — Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223721 — Masimo Stork | Masimo Corporation Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230501 — Spirobank Oxi | Mir Medical International Research USA Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233237 — xeo+ Family | Cutera, Inc. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231825 — Panther TPS | Prowess, Inc. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230949 — ARTIS pheno (VE30A) | Siemens Medical Solutions USA, Inc. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232939 — IPL Hair Removal Device | Shenzhen Borria Technology Co., Ltd. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230050 — Body Temperature Software (BTS) | Fitbit, LLC Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232957 — Sterile and Non-Sterile Ultrasound Gels | Jianerkang Medical Co., Ltd. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232875 — Vial Adapter 20mm | West Pharma. Services IL, Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231801 — MedHealth DVT compression Devices MHH900S/MHH900E | Medhealth Medical Limited Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231645 — PherDal® At-Home Insemination Kit | Pherdal Fertility Science, Inc. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230950 — ARTIS icono (VE30A) | Siemens Medical Solutions USA, Inc. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232580 — Disposable Endobronchial Blocker Tube | Shenzhen Insighters Medical Technology Co., Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231721 — Disposable Hot Biopsy Forceps | Beijing Zksk Technology Co., Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223470 — C50 | Sopro Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233374 — Secret Pro | Ilooda Co,., Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233670 — Ascension Silicone MCP; Ascension Silicone PIP | Ascension Orthopedics, Inc. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231570 — StrokeViewer Perfusion | Nico-Lab B.V. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231887 — ARIX Ankle Distal Tibia System | Jeil Medical Corporation Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233227 — VELYS Robotic-Assisted Solution | Depuy Ireland UC Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232401 — Disposable Veress Needles | Hangzhou Kangji Medical Instrument Co., Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233648 — Millipede 088 Access Catheter | Perfuze, Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233647 — VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231181 — bright CT | Dentium Co., Ltd (Ict Branch) Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232283 — PhySoftAMS® | Physician Software Systems, LLC Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232455 — SofWave System | Sofwave Medical, Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231039 — CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230964 — Power Wheelchair (N5909) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233594 — Genesys Spine 3DP AIS-C II Cervical Interbody System | Genesys Spine Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232680 — fMRI Hardware System | Nordicneurolab AS Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231870 — CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | Ge Medical Systems Information Technologies, Inc. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231803 — Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230852 — HemosIL Chromogenic Factor IX | Instrumentation Laboratory Company Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232572 — Kalitec Navigated Instrument System | Kalitec Direct, LLC Doing Business AS Kalitec Medical Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231337 — EndeavorRx | Akili Interactive Labs, Inc. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232652 — Anatomical Plating System (various) | Tyber Medical, LLC Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233811 — DT Controlled Phototherapy Equipment | Daavlin Distributing Co. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232231 — QP-Brain® | Quibim S.L. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232063 — SaliPen | Saliwell , Ltd. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233621 — NeuroStar Advanced Therapy System (Version 3.8) | Neuronetics Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232237 — Tyto Insights for Wheeze Detection | Tyto Care , Ltd. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232077 — Atalante X | Wandercraft SAS Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232863 — Radiant Renewal Skincare Wand (HD-15, HD-15A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230742 — ACCLARENT AERA Eustachian Tube Dilation System | Acclarent, Inc. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |