510(k) Clearances — Page 176
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K222214 — ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | Thi Total Healthcare Innovation GmbH Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223911 — Lumen 155-SF | Intricon Corporation Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232903 — Legend X Platform | Pollogen, Ltd. Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231899 — HAtetracell-C Titanium Cervical IBF System | Innovasis, Inc. Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232151 — Dynamic TiBase | Talladium España, SL Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232089 — SOZO Pro | ImpediMed Limited Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232020 — Iontophoresis Electrodes | Top-Rank Health Care Co., Ltd. Mon Oct 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231725 — Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) | Hunan Endoso Life Technology Co., Ltd. Mon Oct 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232118 — ANDORATE® Valve Kit | Ga Health Company Limited Mon Oct 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230570 — Willow Generation 3 Breast Pump | Willow Innovations, Inc. Mon Oct 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230249 — Ikshana | Immersivetouch 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) |
| K211676 — Motiva Flora SmoothSilk Tissue Expander | Motiva USA, LLC 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) |
| K223863 — BONHAWA Respiratory Humidifier | Telesair, 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) |
| 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) |
| K230495 — Serena Sleep Night Guard | Meris Investment Group 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) |
| K232481 — RIGEL 3DR Anterior Cervical Corpectomy System | MiRus, LLC 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) |
| 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) |
| 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) |
| K232429 — Titan Dental Design | Clearadvance, LLC 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) |
| 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) |
| K231475 — MONTAGE-QS Settable, Resorbable Bone Putty | Orthocon, 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) |
| K230650 — Monopolar Electrode Surgical Instrument | Vhmed (Nantong) Co. , Ltd. 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) |
| K231551 — Stethophone | Sparrow Acoustics, Inc. Thu Oct 12 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) |
| 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) |
| K230707 — Skypro, Surgical Gown 6021 | Skypro Medical Supplies Company 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) |
| K231814 — ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, 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) |
| 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) |
| K231574 — Scenaria View 4.2 | FUJIFILM Healthcare Americas Corporation 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) |
| 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) |