| NeurotriS (SX2500); NeurotriS (SX3800) (K251909) | A-1 Engineering | 2025-09-03 |
| SignalNED System (Model RE) (K251726) | Forest Devices, Inc. | 2025-09-03 |
| PV01 PVDF Effort Sensor (K251480) | Neurotronics, LLC | 2025-08-29 |
| NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL (K250285) | Raumedic AG | 2025-08-29 |
| OTC 4-Channel Rechargeable TENS Unit (K251429) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-08-28 |
| NeuroEars-Anna™ (K243709) | Neuroears, Inc. | 2025-08-25 |
| Sparrow Ascent (K251246) | Spark Biomedical, Inc. | 2025-08-25 |
| Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) (K250784) | Shenzhen Yicai Health Technology Co., Ltd. | 2025-08-21 |
| Delphi-MD System (DEN250002) | Quantalx Neuroscience, Ltd. | 2025-08-20 |
| Apollo TMS Therapy System (K243539) | Mag & More GmbH | 2025-08-18 |
| Evolution Spine Navigation Instruments (K250167) | Evolution Spine | 2025-08-18 |
| OneRF Trigeminal Nerve Radiofrequency Probes (K251243) | Neuroone Medical Technologies Corp. | 2025-08-15 |
| CP Relief Wand Rx - TENS/NMES (K252236) | N & C Holdings, LLC | 2025-08-15 |
| Electrotherapy Electrodes (K250841) | Baisheng Medical Co., Ltd. | 2025-08-13 |
| RelieVRx (Pico G3) (K251519) | Appliedvr | 2025-08-13 |
| MagVenture TMS Therapy System (K251125) | Tonica Elektronik A/S | 2025-08-11 |
| Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (K243531) | Integra Lifesciences Production Corporation | 2025-08-08 |
| MagVenture TMS Therapy System (K251119) | Tonica Elektronik A/S | 2025-08-08 |
| OptiVu™ Shoulder (K252170) | Mr Surgical Solutions, LLC | 2025-08-08 |
| BTL-199 (K250309) | BTL Industries, Inc. | 2025-08-07 |
| GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) (K251247) | Boston Scientific Neuromodulation Corporation | 2025-08-07 |
| Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) (K243552) | Integra Lifesciences Production Corporation | 2025-08-06 |
| Sleep Watch (K251574) | Ambulatory Monitoring, Inc. | 2025-07-31 |
| NextAR(TM) Spine (K250477) | Medacta International S.A. | 2025-07-31 |
| T65 (9016E061-) (K252032) | Tonica Elektronik A/S | 2025-07-30 |
| CORUS™ Navigation System-GX (K251060) | Providence Medical Technology, Inc. | 2025-07-30 |
| 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) (K251187) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-28 |
| Fusion Craniofacial Implant; Fusion Skull Implant (K250334) | Kelyniam Global, Inc. | 2025-07-25 |
| Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) (K251073) | Innovasis, Inc. | 2025-07-23 |
| VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) (K251505) | Alafair Biosciences | 2025-07-22 |
| MF SC GEN2 Facial Toning System (K252218) | Micro Current Technology, Inc. | 2025-07-18 |
| VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) (K251175) | Alafair Biosciences | 2025-07-17 |
| StimTrial Neuromodulation System (K243782) | Bioventus, LLC | 2025-07-16 |
| NightWatch+ US (K243199) | Livassured BV | 2025-07-12 |
| Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System (K251472) | Inion OY | 2025-07-11 |
| Microcurrent Facial Device (CEC101, EE0101, EEI101) (K244004) | Shenzhen Dachi Communication Co., Ltd. | 2025-07-10 |
| OptiVu™ Shoulder (K250108) | Mr Surgical Solutions, LLC | 2025-07-09 |
| EZ-FIDUCIALS (K250505) | Phasor Health, LLC | 2025-07-09 |
| ExcelsiusXR™ (K241525) | Globus Medical, Inc. | 2025-07-08 |
| TalisMann Neuromodulation System (K243678) | Bioventus, LLC | 2025-07-03 |
| Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) (K250286) | The Magstim Company Limited | 2025-07-03 |
| Felix NeuroAI System (K250096) | Fasikl Incorporated | 2025-07-01 |
| Ampa One System (AMPA-001) (K251210) | Neuromodulatory Devices & Applications | 2025-06-27 |
| External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters (K242974) | Sophysa | 2025-06-20 |
| TMINI Miniature Robotic System (K250877) | THINK Surgical, Inc. | 2025-06-20 |
| Navient Image Guided Navigation System (ENT) (955-NC-NC) (K243053) | Claronav | 2025-06-20 |
| EpiMonitor (K250515) | Empatica S.r.l. | 2025-06-19 |
| SPINEART Navigation Instrument System (K242933) | Spineart SA | 2025-06-18 |
| COAPTIUM Connect with TISSIUM LIGHT (DEN240066) | Tissium SA | 2025-06-17 |
| Geister K-Rex rongeurs (K242759) | Geister Medizin Technik GmbH | 2025-06-06 |
| Synchrony (20-3000) (K242704) | Synapse Biomedical, Inc. | 2025-06-05 |
| Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (K242464) | Medtronic Navigation, Inc. | 2025-06-05 |
| Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) (K251433) | Surgify Medical OY | 2025-06-04 |
| Paradigm System (K250879) | Proprio, Inc. | 2025-06-04 |
| EVAC (K243205) | Phasor Health, LLC | 2025-06-03 |
| Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II (K251315) | Remex Medical Corp. | 2025-05-29 |
| TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) (K243856) | Shenzhen Astec Technology Co., Ltd. | 2025-05-29 |
| Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) (K242841) | ABBOTT MEDICAL | 2025-05-27 |
| NeuroMatch (K250239) | LVIS Corporation | 2025-05-23 |
| Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575) | Brain Navi Biotechnology Co., Ltd. | 2025-05-23 |
| SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 (K250361) | Geske Beauty Tech GmbH | 2025-05-23 |
| HJY VisualNext 3D Endoscopic Vision System (K243429) | Hjy Smart Medical Device Co., Ltd. | 2025-05-21 |
| OTS Hip (K250086) | Ortoma AB | 2025-05-16 |
| Mixed Reality Spine Navigation (K242569) | Brainlab AG | 2025-05-16 |
| OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) (K250213) | Stryker Instruments | 2025-05-15 |
| Nerivio; Nerivio Infinity (K250405) | Theranica Bio-Electronics, Ltd. | 2025-05-14 |
| Helios Dura Regeneration Matrix (K250420) | Helios Biomedical, Inc. | 2025-05-14 |
| TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) (K250360) | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-05-11 |
| TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) (K250053) | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-05-09 |
| Altus Spine Navigation System (K243419) | Altus Partners, LLC | 2025-05-08 |
| CIONIC NEURAL SLEEVE (NS-200) (K243828) | Cionic, Inc. | 2025-05-02 |
| Neu Platform (K250153) | Neuhealth Digital , Ltd. | 2025-04-25 |
| Mako Total Knee Application (3.0); Hybrid Tip Pointer (K250608) | Mako Surgical Corp. | 2025-04-25 |
| Freespira Breathing System (K233337) | Freespira, Inc. | 2025-04-24 |
| Dynamis Robotic Surgical System (K243326) | LEM Surgical AG | 2025-04-23 |
| Minder System (DEN240062) | Epi-Minder Pty, Ltd. | 2025-04-17 |
| Ultimate rTMS (K243460) | Brain Ultimate, Inc. | 2025-04-17 |
| Ultimate rTMS for OCD (M-series) (K243459) | Brain Ultimate, Inc. | 2025-04-17 |
| Medyssey Navigation System (K242806) | Medyssey Co, Ltd. | 2025-04-16 |
| DCM (PW-DCM) (K243513) | Pneumowave, Ltd. | 2025-04-16 |
| Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) (K250094) | Neuralynx, Inc. | 2025-04-14 |
| CT-132 (DEN240064) | Click Therapeutics, Inc. | 2025-04-11 |
| Canvas Dx (K243558) | Cognoa, Inc. | 2025-04-11 |
| NEAT 001 (K250058) | Brain Electrophysiology Laboratory Company, LLC | 2025-04-10 |
| cryoICE cryoXT cryoablation probe (cryoXT) (K250371) | AtriCure, Inc. | 2025-04-10 |
| autoSCORE (V 2.0.0) (K243743) | Holberg Eeg AS | 2025-04-09 |
| AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) (K250752) | Integra LifeSciences Corporation | 2025-04-09 |
| Ceribell Seizure Detection Software (K241589) | Ceribell, Inc. | 2025-04-09 |
| Patch-TEA (Model TRI-21) (K243613) | Transtimulation Research, Inc. | 2025-04-09 |
| Jmoon Conductive Gel (K243749) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-04-08 |
| Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) (K250033) | Guangzhou Pinzhi Medical Technology Co., Ltd. | 2025-04-07 |
| EyeBOX EBX-4.1 (K242116) | Oculogica, Inc. | 2025-04-04 |
| Salvo® Robotic Navigation Instruments (K243514) | Spine Wave, Inc. | 2025-04-03 |
| Progenix Select Stim (K242460) | Progenix, LLC | 2025-04-02 |
| FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (K243659) | SeaSpine Orthopedics Corporation | 2025-04-02 |
| Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) (K243889) | Orthocell, Ltd. | 2025-04-02 |
| Nerve Wrap (07-DW-001-TAB) (K242113) | Biocircuit Technologies, Inc. | 2025-04-02 |
| Préime DermaFacial (MicroT) (K243072) | EMA Aesthetics , Ltd. | 2025-04-01 |
| Layer 7-T (K242618) | Precision Neuroscience, Corp. | 2025-03-30 |
| Neuro Omega System; NeuroSmart System (K250601) | Alpha Omega Engineering , Ltd. | 2025-03-30 |