510(k) Clearances — Page 106
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K242884 — Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242927 — Suction Irrigation Tubing Set | Advamedix, GmbH Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242203 — BriefCase-Quantification | Aidoc Medical , Ltd. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242722 — Manual Wheelchair (MASY23) | Sichuan Ast Medical Equipment Co., Ltd. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242871 — ATTUNE Revision Hinge Knee | Depuy Ireland UC Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242596 — Versalock Mini and Micro Plating System | GM Dos Reis Industria e Comercio Ltda. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241319 — SKR 3000 | Konica Minolta, Inc. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242998 — GMReis Ankle Plating System | GM Dos Reis Industria e Comercio Ltda. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241495 — Jazz Classic | Jazz Imaging Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232520 — Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH | Shenzhen Smallsignal Technology Co., Ltd. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242874 — Gating Reflector Block | Varian Medical Systems, Inc. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243405 — Xpert vanA | Cepheid® Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242799 — PliaFX Flo | Lifenet Health Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241157 — Secret MAX Multi-platform RF System | Ilooda Co,., Ltd. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242414 — TiLink-P Joint Fusion System | SurGenTec, LLC Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242553 — MIRARI® Cold Plasma System ( GV-M2-01) | General Vibronics, Inc. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241210 — Luja Coude | Coloplast Corp. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240569 — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber | Fink Engineering Pty, Ltd. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242291 — SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle | Sol-Millennium Medical, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240716 — AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232965 — Leg Massager (Models:RP-ALM070H, RP-ALM071H) | Shenzhen Ruiyi Business Technology Co., Ltd. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240856 — Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | Osartis GmbH Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242517 — ProAM ACDF System | Pro Surgical, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242521 — Estar-ZE | Osstem Implant Co., Ltd. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241843 — TD-7301 Spirometer (TD-7301) | Gostar Co., Ltd. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243164 — INDIBA COMPACT devices | Indiba S. A. U. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242359 — Strain AI (SAI001) | Exo, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242520 — Element Vascular Access System | Penumbra, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240746 — Neurovascular Access System Family | Q'Apel Medical, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242363 — HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241603 — Powered Wheelchair (NXN20-208, NXN20-211) | Zhejiang Nysin Medical Co., Ltd. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243064 — ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test | Eterbio, Inc. Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243323 — Iconix Knotless Anchor | Riverpoint Medical Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242293 — Medical Thulium Fiber Laser Systems (UroFiber 60Q) | Rhein Laser Technologies Co., Ltd. Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242028 — Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) | Dongguanshi Yiyingmei Technology Co., Ltd. Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243277 — Freedom® Medial Congruent Liner | Maxx Orthopedics, Inc. Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242523 — ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242516 — EUROPA Posterior Cervical Fusion System | MiRus, LLC Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242102 — CerroZone Mini | Cerrozone, LLC Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221349 — XPER Technology PREMIUM Pro Blood Glucose Monitoring System | Taidoc Technology Corporation Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243045 — BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) | Braxx Biotech Co., Ltd. Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242496 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | Eieling Technology (Shenzhen) Limited Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243316 — XENOVIEW 3.0T Chest Coil | Polarean, Inc. Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221813 — Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242930 — Natus BrainWatch System | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241747 — Saige-Dx | DeepHealth, Inc. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242402 — Power wheelchair | Zhejiang Zhonglei Medical Technology Co. , Ltd. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241700 — Tenex 2nd Generation System | Trice Medical, Inc. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242329 — CT Collaboration Live | Philips Healthcare (Suzhou) Co., Ltd. Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242471 — Power Wheelchair (W5538) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Mon Nov 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |