| K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. Oct 6, 2023 |
| K232760 — Swoop® Portable MR Imaging System® | Hyperfine, Inc. Oct 6, 2023 |
| K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. Oct 6, 2023 |
| K231300 — Nutricair Enteral Syringe with ENFit | Cair Lgl Oct 6, 2023 |
| K232480 — ProtekDuo Veno-Venous Cannula Sets | Cardiacassist, Inc. Oct 6, 2023 |
| K232056 — IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 | Dongguan Lide Electric Appliance Co., Ltd. Oct 6, 2023 |
| K223905 — Vivio® LVEDP System | Avicena, LLC Oct 6, 2023 |
| DEN220087 — Edison System | HistoSonics, Inc. Oct 6, 2023 |
| K232407 — Cautery Protective Actuation System (CPAS) | Safer Surgeries Medical Devices, LLC Oct 6, 2023 |
| K230853 — EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. Oct 6, 2023 |
| K232044 — Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. Oct 6, 2023 |
| K232173 — Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. Oct 6, 2023 |
| K231603 — Standard Staple-Line Reinforcement (SSLR23) | Standard Bariatrics, Inc. Oct 6, 2023 |
| K232055 — Vial Adapter | Shanghai Lingfu Technology Co., Ltd. Oct 6, 2023 |
| K230777 — Patient Examination Gloves | 3A Glove Sdn. Bhd. Oct 6, 2023 |
| K223926 — VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | Medimaging Integrated Solution, Inc (Miis) Oct 6, 2023 |
| K221777 — Disposable Sterile Syringe | Weihai Shengjie Medical Technology Co., Ltd. Oct 6, 2023 |
| K230144 — Denti.AI Detect | Denti.Ai Technology, Inc. Oct 6, 2023 |
| K232046 — Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection | Xeridiem Medical Devices, A Spectrum Plastics Group Company Oct 6, 2023 |
| K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories Limited Oct 5, 2023 |
| K232279 — LifeStyles NRL Textured Condom | Suretex Limited Oct 5, 2023 |
| K232367 — cmAngio® V1.0 | Curemetrix, Inc. Oct 5, 2023 |
| K232395 — ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD | Biomérieux Oct 5, 2023 |
| K231001 — DeepTek CXR Analyzer v1.0 | Deeptek Medical Imaging Pvt, Ltd. Oct 5, 2023 |
| K223740 — Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) | Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. Oct 5, 2023 |
| K230780 — MFG-05 | Zimmer Medizinsysteme GmbH Oct 5, 2023 |
| K221550 — Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited Oct 5, 2023 |
| K233044 — Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. Oct 5, 2023 |
| K231078 — All-Suture Anchor | Riverpoint Medical, LLC Oct 5, 2023 |
| K230070 — MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® | Promamedical, Inc. Oct 5, 2023 |
| K232704 — Clarius Ultrasound Scanner | Clarius Mobile Health Corp. Oct 5, 2023 |
| K230242 — OsteoCentric Dental Implant System | OsteoCentric Technologies Oct 5, 2023 |
| K232675 — Heating Tens, FT-615 | Hivox Biotek, Inc. Oct 5, 2023 |
| K231025 — EFAI NeuroSuite CT ICH Assessment System | Ever Fortune.Ai, Co., Ltd. Oct 4, 2023 |
| K232023 — Momentum Spine | Momentum Health, Inc. Oct 4, 2023 |
| K232763 — Electrode Handpieces (VCT, RFTV, BMDT series) | RF Medical Co., Ltd. Oct 4, 2023 |
| K232844 — The IQoolTM System | Braincool AB Oct 4, 2023 |
| K232767 — Nautilus VF ECMO Oxygenator | Mc3, Inc. Oct 4, 2023 |
| K230135 — Copioumed Chemotherapy Isolation Gown | Copioumed International, Inc. Oct 4, 2023 |
| K231398 — VUNO Med-DeepBrain | Vuno, Inc. Oct 4, 2023 |
| K231567 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) | Better Care Plastic Technology Co., Ltd. Oct 4, 2023 |
| DEN230002 — DuraGraft | Marizyme, Inc. Oct 4, 2023 |
| K231772 — V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Oct 3, 2023 |
| K232406 — KARL STORZ OR1 SCB CONTROL (WU300) | Karl Storz SE & CO. KG Oct 3, 2023 |
| K232094 — Orchid Safety Release ValveTM | Linear Health Sciences, LLC Oct 3, 2023 |
| K232914 — SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | STERIS Corporation Oct 3, 2023 |
| K232722 — endo.digital Platform | DreaMed Diabetes, Ltd. Oct 3, 2023 |
| K232918 — enspire 300 Series Automated Endoscope Reprocessor | STERIS Corporation Oct 3, 2023 |
| K232762 — dS Breast Coil 7ch 1.5T | Invivo Corporation (Business Trade Name: Philips) Oct 3, 2023 |
| K232712 — uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. Oct 3, 2023 |