| WHILL Model R (K242760) | Whill, Inc. | 2025-01-06 |
| DermiSphere Dermal Template (K241904) | Fesariustherapeutics, Inc. | 2025-01-06 |
| INNOVISION-EXII (K242119) | Dk Medical System | 2025-01-03 |
| Elemental Granulate (K241283) | Zinkh NV | 2025-01-03 |
| Clarify DL (K241350) | Ge Medical Systems Israel, Functional Imaging | 2025-01-03 |
| syngo.CT Dual Energy (K241757) | Siemens Medical Solutions USA, Inc. | 2025-01-03 |
| EVOLVE Nitric Oxide Delivery System (K242578) | Mallinckrodt Manufacturing, LLC | 2025-01-03 |
| Synapsys VHIT (K242726) | Inventis S.R.L. | 2025-01-03 |
| Inbella RF System (K243737) | Inbella Medical, Inc. | 2025-01-03 |
| NobelProcera Zirconia Implant Bridge (K240346) | Nobel Biocare AB | 2025-01-03 |
| i-STAT hs-TnI cartridge with the i-STAT 1 System (K240984) | Abbott Point of Care, Inc. | 2025-01-03 |
| Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive (K250015) | Ormco Corporation | 2025-01-03 |
| DUET-V (Model: ESK-3261DV) (K233118) | Eunsung Global Corp | 2025-01-03 |
| JLK-ICH (K243363) | JLK, Inc. | 2025-01-03 |
| GBR System (K233419) | Proimtech Saglik Urunleri Anonim Sirketi | 2025-01-03 |
| PENTAX Medical Video Colonoscope (EC38-i20cWL) (K242110) | Pentax of America, Inc. | 2025-01-03 |
| Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) (K242789) | Dongguan Laiguang Electronic Technology Co., Ltd. | 2025-01-02 |
| Wave Electrode (AE02-60); Wave Electrode (AE02-50) (K242326) | Bionit Labs Srl | 2025-01-02 |
| Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) (K243049) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2025-01-02 |
| Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) (K242448) | Anhui Jbh Medical Apparatus Co., Ltd. | 2025-01-02 |
| Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter (K241388) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2025-01-02 |
| Haemostasis Clips (K241005) | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | 2025-01-02 |
| CrystLCare™ PRO Biorestorative, Fluoride-Plus (K241568) | GreenMark Biomedical, Inc. | 2025-01-02 |
| Ortho AI (K241696) | Ortho Ai, LLC | 2025-01-02 |
| Ezra Flash (K242334) | Ezra Ai, Inc. | 2025-01-02 |