25 510(k) decisions in the last 30 days (sample).
Automate alerts: Watch 510(k) clearances and receive only new or updated rows each run.
Run FDA device clearances monitor on Apify| Device | Type | Applicant | Product code | Decision |
|---|---|---|---|---|
| Elecsys EBV VCA IgG | 510(k) | Roche Diagnostics | LSE | 2026-10-02 |
| Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | 510(k) | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | IYN | 2026-10-02 |
| OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts | 510(k) | OsteoCentric Technologies | HWC | 2026-10-02 |
| TDM Large Bone Plate and Screw System | 510(k) | Tdm Co., Ltd. | HRS | 2026-10-02 |
| Elecsys EBV EBNA IgG | 510(k) | Roche Diagnostics | LSE | 2026-10-02 |
| Xpert Xpress CoV-2/Flu plus | 510(k) | Cepheid® | QOF | 2026-10-02 |
| REMEX-T(K)100C | 510(k) | Remedi, Inc. | IZL | 2026-10-02 |
| Lung Guidance | 510(k) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | QJU | 2026-10-02 |
| Response Ortho Smart Fixator - Hexapod System | 510(k) | Response Ortho Solutions, LLC | KTT | 2026-10-02 |
| cCeLL405 | 510(k) | VPIX Medical, Inc. | QFX | 2026-10-02 |
| Neurora | 510(k) | Argus Cognitive, Inc. | QPF | 2026-10-02 |
| Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14) | 510(k) | Shenzhen Ninenovo Technology Limited | DQA | 2026-10-02 |
| Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System | 510(k) | Spinal Simplicity, LLC | PEK | 2026-10-02 |
| Medical Monitor (32MD08WC) | 510(k) | Lg Electronics.Inc | PGY | 2026-10-02 |
| MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor | 510(k) | Steris | FEB | 2026-10-02 |
| AnyPlus II Spinal Fixation System | 510(k) | GS Medical Co., Ltd. | NKB | 2026-10-02 |
| Ventricular Catheters, Thomale Catheter | 510(k) | Aesculap, Inc. | JXG | 2026-10-02 |
| CVS Advanced PLUS Blood Glucose Monitoring System | 510(k) | I-Sens, Inc. | NBW | 2026-10-02 |
| Plenity-V (MC0979 / GS110) | 510(k) | Gelesis SRL | QFQ | 2026-10-02 |
| Hemostatic Clip | 510(k) | Anrei Medical (Hz) Co., Ltd. | PKL | 2026-10-02 |
| AltiVate Reverse® Glenosphere with RAVN Technology | 510(k) | Encore Medical L.P. | PHX | 2026-10-02 |
| stentFIX System Set (100.50n) | 510(k) | Ovesco Endoscopy AG | PKL | 2026-10-02 |
| OAB Delivery Catheter | 510(k) | Cognition Medical Corp. | QJP | 2026-10-02 |
| ZSAlign Cervical Interbody System | 510(k) | ZSFab, Inc. | OVE | 2026-10-02 |
| Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) | 510(k) | Barco NV | PGY | 2026-10-02 |