510(k) Clearances — Page 162
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231805 — qXR-LN | Qure.Ai Technologies Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232717 — Apex Locator (AL-Pex), Apex Locator (AL-Pex+) | Changzhou Haili Medical Co., Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233264 — Anthogyr INTEGRAL Guided Surgery Cassettes | Anthogyr Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234043 — 3M Transbond Orthodontic Adhesive | 3M Unitek Orthodontic Products Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230267 — NeuMoDx CT/NG Assay 2.0 | Neumodx Molecular, Inc. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232338 — Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 | Alicn Medical Shenzhen, Inc. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233742 — CloudTMS Edge for OCD | Teleemg, LLC Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230020 — BioTraceIO Lite | Techsomed Medical Technologies , Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233734 — Interson USB Ultrasound System | Interson Corporation Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232535 — MAGNETOM Sola; MAGNETOM Altea | Siemens Medical Solutions USA, Inc. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223745 — Novae® Dual Mobility System, Hype® Hip System | Serf Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233027 — NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232881 — Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder | Jiangsu Kangbao Medical Equipment Co., Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233104 — SofWave System | Sofwave Medical, Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233423 — Tyber Medical Anatomical Plating System Line extension to the Mini-Frag System | Tyber Medical, LLC Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233112 — HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231531 — Pediarity | Hinlab, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231307 — Elos Accurate Customized Abutment | Elos Medtech Pinol A/S Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233276 — Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232320 — iSR`obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223359 — LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing | Huizhou Foryou Medical Devices Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223729 — FLOWpresso | Medella Health Limited Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221753 — Kangbeier Child Surgical Mask | Xinxiang Kangbeier Medical Technology Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233498 — Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233396 — Cannulated Screw System | Smith & Nephew, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232329 — Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter | Medivators (A Subsidiary of Steris Corporation) Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232784 — RELiZORB® | Alcresta Therapeutics, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | Sysmex America, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231027 — KaiBiLi Extended ViralTrans | Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232944 — CALLISTO eye | Carl Zeiss Meditec, AG Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233018 — PICOSECOND Nd:YAG Laser System | Ids, Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233465 — RadiForce MX317W | Eizo Corporation Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232579 — Twoplus Applicator | Hannah Life Technologies Pte , Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231889 — Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) | Ultrasound Biotechnology (Shanghai) Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233741 — Hoffmann LRF System | Stryker GmbH Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232888 — Disposable Laryngeal Electrodes | Suzhou Haishen Medical Device Associates Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232744 — syngo Virtual Cockpit (VB10A) | Siemens Healthcare GmbH Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233154 — SkyOPS Orthopedic Plate System | Sky Surgical, LLC Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231099 — SMR Hybrid Glenoid System | Lima Corporate S.P.A. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233813 — Bearing nsPVA Express | Merit Medical Systems, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233016 — Dental Glass Ceramics | Shenzhen Yurucheng Dental Materials Co., Ltd. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232870 — TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) | Varian Medical Systems, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233848 — Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | Gynesonics, Inc. Thu Dec 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231968 — Tactoset® Injectable Bone Substitute | Anika Therapeutics, Inc. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231354 — Pocket Ultrasound System (C10) | Beijing Konted Medical Technology Co.,Ltd Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223585 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear | Yung Sheng Optical Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233017 — TM Plating System | Tyber Medical, LLC Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232992 — 10THERMA | Tentech, Inc. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232048 — Cogent Hemodynamic Monitoring System; Cogent HMS | Icu Medical Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232017 — ARK Methotrexate II Assay | Ark Diagnostics, Inc. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |