| aprevo® cervical interbody system (K252894) | Carlsmed, Inc. | 2026-01-06 |
| V-DAC Catheter (K251097) | Vesalio, Inc. | 2026-01-06 |
| Medconn 8K Glycated Hemoglobin Test System (K252749) | Shanghai Medconn Medical Technology Co., Ltd. | 2026-01-06 |
| Pen Needle (K252886) | Hh Global Technology, Inc. | 2026-01-06 |
| TRILEAP Plating System (K253178) | Crossroads Extremity Systems | 2026-01-06 |
| Sensilift Pro (ST300XXYYZZZ) (K250341) | El Global Trade, Ltd. | 2026-01-06 |
| ChartCheck (RADCH V1.6) (K252988) | Radformation, Inc. | 2026-01-05 |
| Disposable Medical Face Mask (K252650) | Makrite Industries, Inc. | 2026-01-05 |
| HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System (K252018) | Samsung Medison Co., Ltd. | 2026-01-05 |
| maiLink (K253008) | Maihub Corp. | 2026-01-05 |
| Puracyn® Plus Antimicrobial Irrigation Solution (K251757) | Innovacyn, Inc. | 2026-01-05 |
| Atellica IM Total PSA II (tPSAII) (K251630) | Siemens Healthcare Diagnostics, Inc. | 2026-01-05 |
| SurfRider 13 Microcatheter (K251668) | Kaneka Americas Holding, Inc. | 2026-01-05 |
| Mobility Scooter (BC-MS310) (K252817) | Ningbo Baichen Medical Devices Co., Ltd. | 2026-01-02 |
| FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit (K253867) | ZuriMED Technologies AG | 2026-01-02 |
| Ready to use Nelaton Catheter (K251178) | Jamjoom Fullcare Corporation | 2026-01-02 |
| MONTAGE XT Cranial Cement (K253854) | Orthocon, Inc. | 2026-01-02 |