| Leksell® Vantage Stereotactic System (K261932) | Elekta Solutions AB | 2026-08-05 |
| xvision Spine system (K261854) | Augmedics, Ltd. | 2026-07-31 |
| Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) (K262253) | Orthalign, Inc. | 2026-07-31 |
| Motivista (CT-155) (K254038) | Click Therapeutics, Inc. | 2026-07-30 |
| SMARTVERTIGO™ Vestibular Assessment System (K260566) | VertigoDx, Inc. | 2026-07-30 |
| TnR Cranial Implant (K251959) | T&R BIOFAB CO., Ltd. | 2026-07-30 |
| Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) (K261410) | Suite 201, National Innovation Centre | 2026-07-30 |
| SPINEART Navigation Instrument System (K261205) | Spineart SA | 2026-07-29 |
| CraniUS Plate (K261058) | CraniUS, LLC | 2026-07-29 |
| TMINI Miniature Robotic System (K261024) | THINK Surgical, Inc. | 2026-07-24 |
| Ion-L Navigated Instruments (K262121) | SurGenTec, LLC | 2026-07-24 |
| FACEGYM Pro Device (HD-109) (K253932) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-07-23 |
| Op.n™ Spine Navigation and Robotic Guidance (K261113) | Ecential Robotics | 2026-07-22 |
| Raney Clips Kit (K253814) | Beijing Honghugaoxiang Science and Technology Development CO | 2026-07-21 |
| Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) (K260578) | Ambu A/S | 2026-07-14 |
| SedLine Sedation Monitor (K260880) | Masimo Corporation | 2026-07-10 |
| Zeta TMS Navigation System (K261471) | Zeta Surgical, Inc. | 2026-07-09 |
| OTS Hip (K261852) | Ortoma AB | 2026-07-01 |
| Ceribell Monitor (K261101) | Ceribell, Inc. | 2026-06-30 |
| UB ERP System (K253767) | Universal Brain | 2026-06-30 |
| BraiN20® (BraiN20) (K253301) | Time IS Brain, S.L. | 2026-06-27 |
| SOMNUM (SOMNUM) (K253390) | Honeynaps Co., Ltd. | 2026-06-27 |
| VERTICALE® Navigation Instruments (K253921) | Silony Medical GmbH | 2026-06-26 |
| Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array (K261442) | Cadwell Industries, Inc. | 2026-06-26 |
| TENS 7000 Rechargeable 4 Channel (TENS 7000H) (K260412) | Shenzhen Dongdixin Technology Co., Ltd. | 2026-06-26 |
| ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) (K260709) | Longeviti Neuro Solutions | 2026-06-25 |
| VELYS™ Robotic-Assisted Solution (K260480) | Depuy Ireland UC | 2026-06-25 |
| Target Xtra Detachable Coil (K261772) | Stryker Neurovscular | 2026-06-24 |
| Ceribell Neurology Review Software (K260998) | Ceribell, Inc. | 2026-06-24 |
| Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) (K261004) | Integra Lifesciences Production Corporation | 2026-06-23 |
| Dynamis Robotic Surgical System (K260369) | LEM Surgical AG | 2026-06-20 |
| CORUS™ Navigation System-GN (K261665) | Providence Medical Technology, Inc. | 2026-06-18 |
| 3D MAC Titanium Cranial Plate (TCP) System (K253116) | The Surgeon General, Department of the Army (TSG-DA) | 2026-06-18 |
| Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) (K253055) | Nordic Kinetics AB | 2026-06-17 |
| TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) (K260425) | Hivox Biotek, Inc. | 2026-06-16 |
| Permatage XT Settable Bone Putty (K261265) | Orthocon, Inc. | 2026-06-15 |
| Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (K261604) | Neuroelectrics Barcelona S.L.U. | 2026-06-13 |
| Cognitive Function Neuroimaging (cfNI) Software (1.0.0) (K253015) | VoxNeuro, Inc. | 2026-06-12 |
| UNEEG EpiSight System (K253607) | Uneeg Medical A/S | 2026-06-11 |
| EyeBOX SNAP (K254086) | Oculogica, Inc. | 2026-06-05 |
| Precision S 4K Sinuscope (K253602) | Stryker Endoscopy | 2026-06-04 |
| MeRT System (K260402) | Wave Neuroscience | 2026-06-03 |
| BioWave BioWraps (K261522) | Biowave Corporation | 2026-06-03 |
| VITA Multi-Function Head Brush (TB-2343F, TB-2442F) (K260179) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 2026-06-03 |
| SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments (K260571) | Life Spine, Inc. | 2026-06-02 |
| Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee (K253507) | Orthalign, Inc. | 2026-06-02 |
| Cube 4D Navigation System, VirtuEye Pro (K261540) | Fiagon GmbH | 2026-06-02 |
| Navigated LLIF Impactable Tracker (K261060) | Tyber Medical, LLC | 2026-05-29 |
| Ulike Clear Zero (YC10 BU) (K260895) | Guangxi Ulike Medical Technology Co., Ltd. | 2026-05-28 |
| STIMPOD NMS460 Nerve Stimulator (K252712) | Algiamed Technologies USA, Inc. | 2026-05-28 |
| CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody (K254157) | Medos International SARL | 2026-05-26 |
| MagVenture Accelerated TMS (aTMS) Therapy System (K260189) | Tonica Elektronik A/S | 2026-05-22 |
| Ion-C Navigation Instruments (K260329) | SurGenTec, LLC | 2026-05-22 |
| Apollo TMS Therapy System;Apollo light TMS Therapy System (K260560) | Mag & More GmbH | 2026-05-22 |
| ROSA® Shoulder System (K260582) | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-05-21 |
| Numen™ Helia Coil Embolization System; NumenFR™ Detachment System (K260351) | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2026-05-20 |
| Portable Neuromodulation Stimulator (PoNS) (K253061) | Helius Medical, Inc. | 2026-05-13 |
| Pytheas Your Guided Trajectory (K252880) | Pytheas Navigation Sas | 2026-05-11 |
| Hydro Irrigation System (K253679) | Stryker Instruments | 2026-05-08 |
| Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) (K253237) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 2026-05-08 |
| Modius Spero (DEN250013) | Neurovalens Limited | 2026-05-08 |
| DeepSkin (DEP100) (K252621) | El Global Trade, Ltd. | 2026-05-08 |
| MR Conditional Cup Electrodes (K254183) | Technomed Europe | 2026-05-07 |
| Zeta Navigation System (K253663) | Zeta Surgical, Inc. | 2026-05-01 |
| Tutamen Self Adhesive Electrodes (K252439) | Dongguan Tutamen Metalwork Co., Ltd. | 2026-05-01 |
| Knee+ (K253805) | Pixee Medical S.A.S. | 2026-04-24 |
| myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) (K253256) | Otto Bock Healthcare Products GmbH | 2026-04-22 |
| Wovyn Depth Electrode (K253970) | Sensomedical Labs, Ltd. | 2026-04-17 |
| Enso for Migraine (K254216) | Hinge Health, Inc. | 2026-04-16 |
| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
| Foundation Surgical Navigated Lateral Disc Prep Instruments (K260011) | Foundation Surgical Group, Inc. | 2026-04-16 |
| SPRINT PNS System (K240974) | Spr Therapeutics, Inc. | 2026-04-14 |
| Pressio 3 Multi-parameter Neuromonitoring System (K252241) | Sophysa | 2026-04-10 |
| VRNT (K254004) | Cognifisense, Inc. | 2026-04-10 |
| EASYMADE-TI (K252251) | CG Bio Co., Ltd. | 2026-04-09 |
| SILKBridge (K260245) | KLISBio S.r.l. | 2026-04-09 |
| SPINEART Navigation Instrument System (K254158) | Spineart SA | 2026-04-09 |
| neuropacs (DEN240071) | Automated Imaging Diagnostics, LLC | 2026-04-03 |
| Ceribell Brain Monitor Headband (K260363) | Ceribell, Inc. | 2026-04-03 |
| SYMPHONY Navigation Ready Instruments (K260240) | Medos International SARL | 2026-03-27 |
| Stealth AXiS Cranial clinical application (K253379) | Medtronic Navigation, Inc. | 2026-03-26 |
| REAL INTELLIGENCE™ CORI™ (K260601) | Blue Belt Technologies, Inc. | 2026-03-26 |
| Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) (K253627) | Surgify Medical OY | 2026-03-26 |
| CUVIS-joint (CJ150) (K252037) | Curexo, Inc. | 2026-03-25 |
| Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (K253098) | Nexstim Oyj | 2026-03-20 |
| TiLink-L Navigation Instruments (K253604) | SurGenTec, LLC | 2026-03-20 |
| Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (K252358) | Nexstim Oyj | 2026-03-20 |
| Noxturnal Web (K260585) | Nox Medical Ehf | 2026-03-20 |
| EUROPA™ Posterior Cervical Fusion Navigated Instruments (K253444) | MiRus, LLC | 2026-03-18 |
| Q Pedicle Instruments (K260546) | K2m, Inc. | 2026-03-17 |
| Cala kIQ Plus (K253587) | Cala Health, Inc. | 2026-03-17 |
| Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (K253447) | Orthocon, Inc. | 2026-03-16 |
| Stealth AXiS™ ENT clinical application (K253395) | Medtronic Navigation, Inc. | 2026-03-16 |
| New Wave System (K260455) | Zeto, Inc. | 2026-03-13 |
| Permatage Flowable, Settable Bone Paste (K253732) | Orthocon, Inc. | 2026-03-13 |
| Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (K260453) | Bionit Labs Srl | 2026-03-12 |
| Onera SleepMap (SLEEPMAP) (K253668) | Onera B.V. | 2026-03-08 |
| Velocity Alpha MR High Speed Surgical Drill System (K253772) | Adeor Medical AG | 2026-03-06 |
| EarliPoint Assessment (K253442) | Earlitec Diagnostics | 2026-03-05 |
| TENS/EMS device (GUSE01) (K253896) | Globalcare Medical Technology Co., Ltd. | 2026-03-04 |