| K232118 — ANDORATE® Valve Kit | Ga Health Company Limited Mon Oct 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230104 — Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL | Anthogyr Mon Oct 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232128 — Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | Shenzhen AOJ Medical Technology Co., Ltd. Sat Oct 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230125 — Neuroblade System | Clearmind Biomedical Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232504 — Calibrate CCX Interbody System | Alphatec Spine, Inc. Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232481 — RIGEL 3DR Anterior Cervical Corpectomy System | MiRus, LLC Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223863 — BONHAWA Respiratory Humidifier | Telesair, Inc. Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223697 — MRI compatibility for existing BioHorizons dental implants and abutments | BioHorizons Implant Systems, Inc. Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231744 — VyLink Spinal Screw System | Vy Spine, LLC Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232437 — Paragon 8F Balloon Guide Catheter | Wallaby Medical Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230495 — Serena Sleep Night Guard | Meris Investment Group Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231642 — Veuron-Brain-pAb3 | Heuron Co., Ltd. Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232822 — Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) | Gbs Commonwealth Co., Ltd. Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231672 — S1 | Medpark Co., Ltd. Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230440 — Xpert® Xpress CoV-2 plus | Cepheid® Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230370 — SpotLight/SpotLight Duo (with DLIR option) | Arineta , Ltd. Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222143 — APIS (R), VERIS (TM) | Sweetbio, Inc. Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231495 — The Evolve System with the Transform Applicator | InMode , Ltd. Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232429 — Titan Dental Design | Clearadvance, LLC Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K211676 — Motiva Flora SmoothSilk Tissue Expander | Motiva USA, LLC Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230741 — Macro & Micro-Test HCG Pregnancy Test Midstream | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232809 — Cross Vascular RF Generator and Footswitch (optional accessory) | Cross Vascular, Inc. Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232838 — Monkey RingsTM External Fixation System | Paragon 28, Inc. Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231486 — Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230707 — Skypro, Surgical Gown 6021 | Skypro Medical Supplies Company Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230650 — Monopolar Electrode Surgical Instrument | Vhmed (Nantong) Co. , Ltd. Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231708 — Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) | Axogen Corporation Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN200076 — ORi | Masimo Corporation Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232802 — TMINI Miniature Robotic System | THINK Surgical, Inc. Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231231 — MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices | Paragon 28, Inc. Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231814 — ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231574 — Scenaria View 4.2 | FUJIFILM Healthcare Americas Corporation Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231152 — Collagen Wound Dressing | Winner Medical Co., Ltd. Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231475 — MONTAGE-QS Settable, Resorbable Bone Putty | Orthocon, Inc. Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222222 — Artemis, Artemis TPO, Artemis MX | Eigen Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231551 — Stethophone | Sparrow Acoustics, Inc. Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232448 — FREEPRINT® splintmaster | Detax GmbH Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232998 — Montage- XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232852 — Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable | Cross Vascular, Inc. Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230717 — Exactech® Vantage® Total Ankle System | Exactech, Inc. Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233233 — EMPHASYS Femoral Stems | Depuy Ireland UC Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231050 — Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230116 — Vital Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232499 — IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) | Shenzhen Lescolton Electrical Appliance Co., Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232460 — Disposable electrosurgical pencil (MD1000) | Shenzhen Mecun Medical Supply Co., Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232070 — Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) | Better Care Plastic Technology Co., Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222025 — G4Derm / G4Derm Plus Synthetic Wound Matrix | Gel4med, Inc. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232574 — VASSALLO GT Crossing14 | Filmec Co. , Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230618 — MegaGen Dental Implant Systems Portfolio - MR Conditional | Megagen Implant Co., Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230220 — NeuViz 128 Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |