| DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (K260069) | Synthes GmbH | 2026-03-09 |
| Onera SleepMap (SLEEPMAP) (K253668) | Onera B.V. | 2026-03-08 |
| Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (K251807) | Olympus Medical Systems Corp. | 2026-03-06 |
| Treace Medical Concepts (TMC) Screw Fixation System (K260361) | Treace Medical Concepts, Inc. | 2026-03-06 |
| Water-based lubricant (K253983) | Guangzhou Haoyimai Trading Co., Ltd. | 2026-03-06 |
| VELYS™ Hip Navigation (K253551) | Depuy Ireland UC | 2026-03-06 |
| EmeryGlide™ (EG18008901) (K253262) | Nano4imaging GmbH | 2026-03-06 |
| TeKBrace Knotless Anchor (K253538) | Theramicro | 2026-03-06 |
| JFord Speculum Sleeve™ (K252208) | Ford Medtech, LLC | 2026-03-06 |
| CVAC Image Processor (K260013) | Calyxo, Inc. | 2026-03-06 |
| BONTREE PLUS (K251818) | Hudens Bio Co., Ltd. | 2026-03-06 |
| Single use stone retrieval balloons (K253132) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-03-06 |
| Bunkerhill Contrast CAC (K260166) | BunkerHill Health | 2026-03-06 |
| Bunkerhill Contrast AVC (K260167) | BunkerHill Health | 2026-03-06 |
| Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) (K253951) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-03-06 |
| Velocity Alpha MR High Speed Surgical Drill System (K253772) | Adeor Medical AG | 2026-03-06 |
| CEPHX3D (K252538) | Orca Dental AI , Ltd. | 2026-03-05 |
| YUWELL® Electronic Blood Pressure Monitor (YE630CR) (K252779) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-03-05 |
| EarliPoint Assessment (K253442) | Earlitec Diagnostics | 2026-03-05 |
| Phantom® Hindfoot TTC/TC Nail System (K253591) | Paragon 28, Inc. | 2026-03-05 |
| AV Cardiac CT (K260169) | Philips Medical Systems Nederland B.V. | 2026-03-05 |
| Magnifico Open (100009900) (K251901) | Esaote, S.p.A. | 2026-03-05 |
| CORIS System (K253267) | Nanosonics Limited | 2026-03-05 |
| Arthrex FibuLock Nail System (K252196) | Arthrex, Inc. | 2026-03-05 |
| Extension tube (K251788) | Zhuhai DR Medical Instruments Co., Ltd. | 2026-03-05 |
| Adhese 2 (K252450) | Ivoclar Vivadent, Inc. | 2026-03-05 |
| Mendit (K260380) | Escala Medical, Ltd. | 2026-03-04 |
| TENS/EMS device (GUSE01) (K253896) | Globalcare Medical Technology Co., Ltd. | 2026-03-04 |
| LifeVac (DEN250012) | Lifevac, LLC | 2026-03-04 |
| ANTERIS Thoracolumbar Plate System (K260015) | SpineCraft | 2026-03-04 |
| Klär Lite (RCW-KL1000) (K253871) | Radcliffe Watts, LLC | 2026-03-04 |
| Dentis SQ-SL AXEL Fixture (K253493) | Dentis Co., Ltd. | 2026-03-04 |
| SureSmile Software (K253565) | Dentsply Sirona, Inc. | 2026-03-04 |
| Active Intramedullary (AIM) Tibial Nail System (K252025) | Satori Orthopaedics, Inc. | 2026-03-04 |
| Aevumed FENIX Suture Anchor (K254306) | Aevumed, Inc. | 2026-03-04 |
| QT Scanner 2000 Model A (K253898) | QT Imaging Holdings, Inc. | 2026-03-04 |
| Electric Wheelchair (MP148) (K253870) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2026-03-04 |
| Healing Abutment System (K251434) | Osstem Implant Co., Ltd. | 2026-03-04 |
| LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) (K253878) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-03-04 |
| 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 (K260365) | Devicor Medical Products, Inc. | 2026-03-04 |
| PathLoc Lumbar Plate System (K251940) | L&K BIOMED Co., Ltd. | 2026-03-03 |
| Annalise Enterprise (K253818) | Harrison-AI Medical Pty, Ltd. | 2026-03-03 |
| ZAFIRA® (K254245) | New Stetic, SA | 2026-03-03 |
| TMINI® Miniature Robotic System (K260010) | THINK Surgical, Inc. | 2026-03-03 |
| Bond-PR™ Universal Adhesive (K260682) | Premier Dental Products Company | 2026-03-03 |
| CO2 Laser Treatment Machine (CFR3M1) (K253920) | Haidari Beauty Technology (Beijing) Co., Ltd. | 2026-03-03 |
| Surgical Face Mask (Ear mount) (K252534) | Zhejiang Hangkang Medical Equipment Co., Ltd. | 2026-03-03 |
| SOTA Cloud Smart Sensor (1.5) (K251793) | Sota Cloud Corp. | 2026-03-03 |
| Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (K260353) | Arthrex, Inc. | 2026-03-03 |
| LED Therapy Light (COB1400, HP1800PRO) (K253874) | Shenzhen Hanhua Opto Co., Ltd. | 2026-03-03 |
| Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) (K253845) | Ram.Shaw Pte. , Ltd. | 2026-03-03 |
| POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (K252487) | Gyrus Acmi, Inc. | 2026-03-02 |
| UltraPrint-Dental Hard Splint UV (K253798) | Guangzhou Heygears IMC., Inc. | 2026-03-02 |
| Arthrex Nano FiberTak Suture Anchor (K254229) | Arthrex, Inc. | 2026-03-02 |
| Clarius Ejection Fraction AI (K253593) | Clarius Mobile Health Corp. | 2026-03-02 |
| 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) (K253771) | Nanjing Devin Medical Technology Co., Ltd. | 2026-03-02 |
| VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (K254054) | Synthes GmbH | 2026-03-02 |
| Microwave Ablation Device (K252632) | Nanjing Dewen Medical Technology Co., Ltd. | 2026-03-02 |
| “FLNT Base” and “FLNT Temp” (K253380) | Liaoning Upcera Co., Ltd. | 2026-03-02 |
| KARL STORZ Mediastinoscopes and Instruments (K260003) | Karl Storz SE & CO. KG | 2026-03-02 |
| Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (K252531) | Myofunctional Research Co. | 2026-03-02 |
| MESI mTABLET SPIRO (K251777) | Mesi D.O.O. | 2026-03-02 |
| Evala Nerve Stimulator (EPNR002) (K253536) | Epineuron Technologies, Inc. | 2026-02-27 |
| Ligence Heart (K253535) | Ligence Uab | 2026-02-27 |
| Atellica CH Diazo Total Bilirubin (D_TBil) (K251998) | Siemens Healthcare Diagnostics, Inc. | 2026-02-27 |
| AViTA Pulse Oximeter (SP61) (K252448) | Avita Corporation | 2026-02-27 |
| LigaMend (K253695) | Riverpoint Medical, LLC | 2026-02-27 |
| One-Stop (K253797) | Mediclus Co., Ltd. | 2026-02-27 |
| C-Lant Port (K252714) | Vigor Medical Technologies , Ltd. | 2026-02-27 |
| HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (K260292) | Atraverse Medical | 2026-02-27 |
| Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) (K253829) | Beijing HuaCheng Taike Technology Co., Ltd. | 2026-02-27 |
| Allday Moisturizing Rinse (K253778) | Elevate Oral Care | 2026-02-27 |
| HKT Anatomical Locking Trauma System (K254249) | Hankil Tech Medical Co., Ltd. | 2026-02-27 |
| Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) (K253828) | Beijing HuaCheng Taike Technology Co., Ltd. | 2026-02-27 |
| Owl Night Guard (K253641) | Owl Dental Lab, Inc. | 2026-02-26 |
| PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid (K253791) | DePuy Mitek, Inc. | 2026-02-26 |
| SWINGO-3D Lumbar Cage System (K254017) | Implanet | 2026-02-26 |
| BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device (K253578) | Aidoc Medical , Ltd. | 2026-02-26 |
| Copioumed AAMI 3 Surgical Gown (K251860) | Copioumed International, Inc. | 2026-02-26 |
| RIB LINK™ Fixation System (K252166) | Globus Medical, Inc. | 2026-02-26 |
| InnovexView (GC146-17, GC150-20, GC155-23) (K254251) | Shanghai AnQing Medical Instrument Co., Ltd. | 2026-02-26 |
| Enbio PRO (K260254) | Enbio Group AG | 2026-02-26 |
| CAPRI (K254271) | ORO Co., Ltd. | 2026-02-26 |
| ENOS Software Guided External Fixation System (K253764) | Disior, Ltd. | 2026-02-26 |
| KARL STORZ ICG Imaging System with RUBINA® Lens (K254242) | Karl Storz SE & CO. KG | 2026-02-26 |
| Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm (K251700) | Speciality Fibres and Materials Limited | 2026-02-26 |
| GMK 3D Metal Tibial Tray Extension (K253328) | Medacta International S.A. | 2026-02-26 |
| ANNE Maternal (K253021) | Sibel Health, Inc. | 2026-02-26 |
| Aster (K254182) | Osteonic Co., Ltd. | 2026-02-26 |
| Remi Impression Material (K251724) | Grindguard, Inc. | 2026-02-25 |
| Electric wheelchair (K253789) | Zhejiang Yikang Medical Technology Co., Ltd. | 2026-02-25 |
| BD Surgiphor™ Antimicrobial Irrigation System (910110) (K253996) | Becton, Dickinson and Company (BD) | 2026-02-25 |
| Mako Total Knee Application (K260222) | Mako Surgical Corp. | 2026-02-25 |
| Konig Bell Circumcision Clamp (K251687) | Medline Industries, LP | 2026-02-25 |
| FIREFLY® Pedicle Screw Navigation Guide (K253472) | Mighty Oak Medical | 2026-02-25 |
| Ventana™ A Anterior Lumbar Interbody System (K253559) | Spinal Elements, Inc. | 2026-02-25 |
| AI Platform 2.2 (AIP002) (K260217) | Exo Imaging | 2026-02-24 |
| IntraSight Plus (K253714) | Philips Image Guided Therapy Corporation | 2026-02-24 |
| OSSIOfiber® Suture Anchor (K254055) | OSSIO , Ltd. | 2026-02-24 |
| Swift Ray 1 (K251678) | Swift Medical, Inc. | 2026-02-24 |