| TMINI® Miniature Robotic System (K260010) | THINK Surgical, Inc. | 2026-03-03 |
| Mako Total Knee Application (K260222) | Mako Surgical Corp. | 2026-02-25 |
| “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set (K252989) | Point Robotics MedTech, Inc. | 2026-02-20 |
| SPRY TMS Therapy System (0550) (K251653) | Soterix Medical, Inc. | 2026-02-20 |
| Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (K252597) | Alphatec Spine, Inc. | 2026-02-19 |
| Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor (K253623) | Stryker Leibinger GmbH & Co KG | 2026-02-19 |
| VERTICALE GPS Instruments (K254148) | Silony Medical GmbH | 2026-02-19 |
| PreOp v3 (K252565) | Clouds of Care | 2026-02-13 |
| STAR RF Ablation System (K251802) | Merit Medical Systems, Inc. | 2026-02-13 |
| Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (K253381) | Medtronic Navigation, Inc. | 2026-02-12 |
| Ceribell Instant EEG Headset (K254033) | Ceribell, Inc. | 2026-02-09 |
| Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories (K252871) | Stryker Leibinger GmbH & Co KG | 2026-02-06 |
| Q Interbody Instruments (K252873) | K2m, Inc. | 2026-02-06 |
| ROSA Knee System with UltraSound Imaging Platform (USIP) (K252058) | Balmoral Medical, LLC | 2026-02-06 |
| Encora X1 (K251517) | Encora, Inc. | 2026-02-05 |
| Navigation Module of the Cortium® System (K252087) | Ulrich Medical USA, Inc. | 2026-02-03 |
| Optima Coil System (OptiOne Coil System) (K254221) | Balt USA, LLC | 2026-01-27 |
| POINT Kinguide Agile Robotic Arm Surgical Stereotactic System (K252755) | Point Robotics MedTech, Inc. | 2026-01-23 |
| Affirm 400 (K251286) | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2026-01-21 |
| NeuroSpan Bridge (K253363) | Auxilium Biotechnologies, Inc. | 2026-01-17 |
| actiTENS mini (K252767) | Sublimed | 2026-01-16 |
| METICULY Patient-specific titanium mesh implant (K252958) | Meticuly Co., Ltd. | 2026-01-14 |
| DYNAMIS™ Navigation System (K252962) | Promethean Restorative, LLC | 2026-01-12 |
| SafeOp 3: Neural Informatix System (K252842) | Alphatec Spine, Inc. | 2026-01-11 |
| NextAR Hip Platform (K252847) | Medacta International S.A. | 2026-01-09 |
| Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models (K253308) | Materialise NV | 2026-01-07 |
| MONTAGE XT Cranial Cement (K253854) | Orthocon, Inc. | 2026-01-02 |
| Genesis Sleep (K252951) | Neurofield, Inc. | 2025-12-31 |
| TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) (K253305) | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-12-31 |
| Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (K252146) | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025-12-23 |
| VEINOPLUS Back (K251958) | Dynapulse Medical | 2025-12-23 |
| TENS&EMS (HZ9151B, HZ9151C, HZ9151D) (K253740) | Hong Qiangxing (Shenzhen) Electronics Limited | 2025-12-23 |
| Aura Glide (FC40) (K252187) | Aura Medical, LLC | 2025-12-23 |
| TMINI Miniature Robotic System (K253661) | THINK Surgical, Inc. | 2025-12-22 |
| EmbraceMini (K252981) | Empatica S.r.l. | 2025-12-22 |
| Paradigm System (K252950) | Proprio, Inc. | 2025-12-15 |
| Hypnos (369054-200) (K250851) | Cadwell Industries, Inc. | 2025-12-14 |
| Target Detachable Coil (K252694) | Stryker Neurovascular | 2025-12-11 |
| Intellidrop (K251598) | Brainspace, Inc. | 2025-12-10 |
| Ceribell Delirium Monitor System (K251936) | Ceribell, Inc. | 2025-12-08 |
| REAL INTELLIGENCE™ CORI™ XT (CORI XT) (K252841) | Blue Belt Technologies, Inc. | 2025-12-05 |
| Spineology Navigation Instruments (K251943) | Spineology, Inc. | 2025-12-04 |
| HippoMind (v1.0) (K251881) | Hippoclinic | 2025-12-03 |
| Sophy Mini Monopressure Valve (SM1) (K250636) | Sophysa | 2025-11-28 |
| NX01 (NX01) (K251550) | Naox Technologies Sas | 2025-11-25 |
| Transcutaneous Electrical Nerve Stimulator (RJTENS-2) (K252688) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2025-11-24 |
| Nelli (Version 7.11) (K251506) | Neuro Event Labs OY | 2025-11-21 |
| Ceribell Infant Seizure Detection Software (K252070) | Ceribell, Inc. | 2025-11-21 |
| Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (K251856) | Everyway Medical Instruments Co.,Ltd | 2025-11-21 |
| LEGACY (K252696) | Phasor Health, LLC | 2025-11-21 |
| Collagen Dura Regeneration Membrane - Repair (K251191) | Collagen Matrix, Inc. | 2025-11-18 |
| DeepRESP (K252330) | Nox Medical Ehf | 2025-11-17 |
| Neurolyser XR (NXR100) (DEN250015) | Fusmobile, Inc. | 2025-11-14 |
| Rosa® Knee System (K251314) | Orthosoft Inc. (d/b/a) Zimmer CAS | 2025-11-13 |
| Synthes Patient Specific Implants (K243715) | Synthes GmbH | 2025-11-12 |
| KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE (K252573) | KLS-Martin L.P. | 2025-11-10 |
| BrainsWay Deep TMS System (K251391) | Brainsway , Ltd. | 2025-11-07 |
| Triathlon Pro (K243131) | Sigma Biomedical | 2025-11-07 |
| mb-FIX Cranial Stabilization Systems (K250423) | Medical Bees GmbH | 2025-11-06 |
| Hubly Drill (H100) (K250815) | Hubly, Inc. | 2025-11-06 |
| EVAC-MRI (K252514) | Phasor Health, LLC | 2025-11-05 |
| Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept (K250363) | Beijing Sinovation Medical Technology Co., Ltd. | 2025-11-05 |
| ExcelsiusGPS™ Instruments (K250599) | Globus Medical, Inc. | 2025-11-05 |
| GREEN (K252060) | Phasor Health, LLC | 2025-10-31 |
| Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (K251381) | Ceribell, Inc. | 2025-10-31 |
| Firebird SI Navigation System (K252088) | Orthofix US, LLC | 2025-10-31 |
| Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (K252160) | Persyst Development, LLC | 2025-10-31 |
| Medi Lift Essential Eye Mask (K250618) | Ya-Man, Ltd. | 2025-10-29 |
| Navigated Instruments (K252742) | Tyber Medical, LLC | 2025-10-28 |
| TECHFIT Patient-Specific Cranial System (K250297) | Techfit Digital Surgery, Inc. | 2025-10-27 |
| OsteoCentric Navigated Instruments System (K250520) | Osteocentric Technologies, Inc. | 2025-10-27 |
| NeuroAlign software (K231897) | Medivis, Inc. | 2025-10-21 |
| InZone IST Detachment System; IZDS Connecting Cable (K251832) | Stryker Neurovascular | 2025-10-17 |
| JOVS Electric Stimulation Beauty Device (JE2) (K250227) | Shenzhen Qianyu Technology Co., Ltd. | 2025-10-17 |
| StealthStation S8 Spine Software (K251282) | Medtronic Navigation, Inc. | 2025-10-17 |
| Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) (K251034) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2025-10-12 |
| Zeta Navigation System (ZNS131-US) (K251927) | Zeta Surgical, Inc. | 2025-10-10 |
| TMINI Miniature Robotic System (K252544) | THINK Surgical, Inc. | 2025-10-10 |
| EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) (K251366) | Nihon Kohden Corporation | 2025-10-09 |
| Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) (K252553) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2025-10-09 |
| PainChek (PainChek Adult) (DEN240073) | Painchek Limited (Ltd.) | 2025-10-06 |
| xvision Spine system (K251639) | Augmedics, Ltd. | 2025-10-03 |
| allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) (K252051) | Tulavi Therapeutics, Inc. | 2025-09-29 |
| SpineAR SNAP (SyncAR Spine) (K252054) | Surgical Theater, Inc. | 2025-09-29 |
| Optima Coil System (Optima Packing Coil System) (K252700) | Balt USA, LLC | 2025-09-26 |
| RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer (K251971) | Stryker Instruments | 2025-09-25 |
| UniBur (K252662) | Nakanishi, Inc. | 2025-09-19 |
| Sunny Plus (Sunny) (K251649) | ShenB Co., Ltd. | 2025-09-18 |
| iGPS Navigation Instruments (K251780) | SI-BONE, Inc. | 2025-09-15 |
| CloudTMS Edge (K250689) | Teleemg, LLC | 2025-09-14 |
| BrainsWay Deep TMS System (K251449) | Brainsway , Ltd. | 2025-09-13 |
| Spine & Trauma Navigation Instruments (K252562) | Brainlab AG | 2025-09-12 |
| Mazor X System / Mazor X Stealth Edition (K251316) | Mazor Robotics , Ltd. | 2025-09-11 |
| OptiVu™ Shoulder (K252530) | Mr Surgical Solutions, LLC | 2025-09-10 |
| Quadsense (Quadsense and Quadsense Pro) (K252524) | Eventum Orthopaedics, Ltd. | 2025-09-09 |
| Coaptium Connect with Tissium Light (K251957) | Tissium SA | 2025-09-08 |
| SOLOPASS 2.0 System (K251317) | Intravent Medical Partners | 2025-09-05 |
| Ball Joint Guide Array (66295) (K250893) | Bayer Medical Care, Inc. | 2025-09-04 |
| Apollo TMS Therapy System (K243700) | Mag & More GmbH | 2025-09-04 |
| NextAR(TM) Shoulder Platform (K251737) | Medacta International S.A. | 2025-09-04 |