| 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 |
| K231960 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether | Anx Robotica Corporation Oct 3, 2023 |
| K230085 — Lung-CAD | Imagen Technologies, Inc. Oct 3, 2023 |
| K232230 — YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE) | Zhenjiang Assure Medical Equipment Co., Ltd. Oct 3, 2023 |
| K232064 — Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) | Isikel Manufacturing, LLC Oct 2, 2023 |
| K232359 — Surgical face mask | Kingstar Medical (Xianning) Co., Ltd. Oct 2, 2023 |
| K221972 — Warantec Custom Abutment | Warantec Co., Ltd. Oct 2, 2023 |
| K230681 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl | Central Medicare Sdn Bhd Oct 2, 2023 |
| K231716 — OsteoFlo® HydroPutty | SurGenTec, LLC Oct 2, 2023 |
| K231520 — tmCMF Solution | Techmah Cmf Oct 2, 2023 |
| K221890 — Elecsys Tg II | Roche Diagnostics Sep 30, 2023 |
| K231622 — REGER Nebulizer Irrigation Cannula | Reger Medizintechnik, GmbH Sep 29, 2023 |
| K231649 — Intraosseous Fusion Device System | Auxano Medical, LLC Sep 29, 2023 |
| K231957 — SafeBreak® Vascular | Lineus Medical Sep 29, 2023 |
| K223085 — Miris Human Milk Analyzer (HMA) | Miris AB Sep 29, 2023 |
| K221274 — StarFormer, TightWave | Fotona D.O.O. Sep 29, 2023 |
| K230591 — TriLEAP Plating System | Crossroads Extremity Systems Sep 29, 2023 |
| DEN220023 — Procise ADL | Procisedx, Inc. Sep 29, 2023 |
| K232299 — CeraPutty | Meta Biomed Co., Ltd. Sep 29, 2023 |
| DEN210056 — Procise IFX | Procisedx, Inc. Sep 29, 2023 |
| K221508 — AnemoCheck Home | Sanguina, Inc. Sep 29, 2023 |
| K231527 — TriALTIS Navigation Enabled Instruments | Medos International Sàrl Sep 29, 2023 |
| K230045 — HipCheck | Stryker Corp. Sep 29, 2023 |
| K230847 — Chemotherapy Gloves | 3A Glove Sdn. Bhd. Sep 29, 2023 |
| K232690 — Amulet Steerable Delivery Sheath | ABBOTT MEDICAL Sep 29, 2023 |
| K223873 — Boppli Infant Blood Pressure Monitor | Pyrames, Inc. Sep 29, 2023 |
| K212769 — DYNEX SmartPLEX MMRV IgG Assay Kit | Dynex Technologies, Inc. Sep 29, 2023 |
| K231628 — BeShape One Device | Beshape Technologies , Ltd. Sep 29, 2023 |
| K232651 — BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation Sep 29, 2023 |
| K221900 — Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation Sep 29, 2023 |
| K232701 — Guardenia (GAR-1) | Advanced Surgical Concepts Sep 29, 2023 |
| K221570 — Antibacterial bandage | Allmed Medical Products Co., Ltd. Sep 29, 2023 |
| K231702 — WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet | OTU Medical, Inc. Sep 29, 2023 |