| K253267 — CORIS System | Nanosonics Limited Thu Mar 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251901 — Magnifico Open (100009900) | Esaote, S.P.A. Thu Mar 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260169 — AV Cardiac CT | Philips Medical Systems Nederland B.V. Thu Mar 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253493 — Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253871 — Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253878 — LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253565 — SureSmile Software | Dentsply Sirona, Inc. Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253870 — Electric Wheelchair (MP148) | Suzhou Master Machinery Manufacturing Co.,Ltd Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251434 — Healing Abutment System | Osstem Implant Co., Ltd. Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253896 — TENS/EMS device (GUSE01) | Globalcare Medical Technology Co., Ltd. Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260365 — Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char | Devicor Medical Products, Inc. Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250012 — LifeVac | Lifevac, LLC Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260380 — Mendit | Escala Medical, Ltd. Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254306 — Aevumed FENIX Suture Anchor | Aevumed, Inc. Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253898 — QT Scanner 2000 Model A | QT Imaging Holdings, Inc. Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252025 — Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260015 — ANTERIS Thoracolumbar Plate System | SpineCraft Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260682 — Bond-PR Universal Adhesive | Premier Dental Products Company Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260010 — TMINI® Miniature Robotic System | THINK Surgical, Inc. Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252534 — Surgical Face Mask (Ear mount) | Zhejiang Hangkang Medical Equipment Co., Ltd. Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253874 — LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto Co., Ltd. Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253920 — CO2 Laser Treatment Machine (CFR3M1) | Haidari Beauty Technology (Beijing) Co., , Ltd. Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253818 — Annalise Enterprise | Harrison-AI Medical Pty, Ltd. Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254245 — ZAFIRA® | New Stetic, SA Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253845 — Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte. , Ltd. Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251940 — PathLoc Lumbar Plate System | L & K Biomed Co., Ltd. Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251793 — SOTA Cloud Smart Sensor (1.5) | Sota Cloud Corp. Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251777 — MESI mTABLET SPIRO | Mesi D.O.O. Mon Mar 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253798 — UltraPrint-Dental Hard Splint UV | Guangzhou Heygears IMC., Inc. Mon Mar 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254229 — Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. Mon Mar 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253593 — Clarius Ejection Fraction AI | Clarius Mobile Health Corp. Mon Mar 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. Mon Mar 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252632 — Microwave Ablation Device | Nanjing Dewen Medical Technology Co., Ltd. Mon Mar 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260003 — KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG Mon Mar 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253771 — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) | Nanjing Devin Medical Technology Co., Ltd. Mon Mar 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253380 — FLNT Base and FLNT Temp | Liaoning Upcera Co., Ltd. Mon Mar 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252531 — Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. Mon Mar 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254054 — VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | Synthes GmbH Mon Mar 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251998 — Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253778 — Allday Moisturizing Rinse | Elevate Oral Care Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253828 — Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) | Beijing HuaCheng Taike Technology Co., Ltd. Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254249 — HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252714 — C-Lant Port | Vigor Medical Technologies , Ltd. Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253829 — Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) | Beijing HuaCheng Taike Technology Co., Ltd. Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253695 — LigaMend | Riverpoint Medical, LLC Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253536 — Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260292 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253535 — Ligence Heart | Ligence Uab Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252448 — AViTA Pulse Oximeter (SP61) | Avita Corporation Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |