| Bullsai Confirm (K243520) | Turing Medical Technologies, Inc. | 2025-03-28 |
| Nurochek-Pro System (K243426) | Headsafe Mfg Pty, Ltd. | 2025-03-27 |
| StarFormer (M008-3T) (K241785) | Fotona D.O.O. | 2025-03-27 |
| NM-01/CPT neurometer (NM-01/CPT) (K240189) | Mde Orvosbiológiai Kutató, Fejleszto, | 2025-03-26 |
| EarliPoint System (K243891) | Earlitec Diagnostics | 2025-03-26 |
| Innovasis Navigation Instruments (K250182) | Innovasis, Inc. | 2025-03-24 |
| REMI Remote EEG Monitoring System (K243185) | Epitel | 2025-03-21 |
| Consolidated Operating Room Equipment (CORE) 2 Console (K243958) | Stryker Instruments | 2025-03-21 |
| ARVIS Surgical Navigation System (K243980) | Kico Knee Innovation Company Pty Limited | 2025-03-21 |
| Knee+ (K243975) | Pixee Medical | 2025-03-20 |
| DOC Band 3D (K244056) | Cranial Technologies, Inc. | 2025-03-17 |
| Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) (K243869) | The Magstim Company Limited | 2025-03-17 |
| mBôs (Monogram mBôs TKA System) (K242121) | Monogram Orthopaedics, Inc. | 2025-03-14 |
| DeepRESP (K241960) | Nox Medical Ehf | 2025-03-14 |
| 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) (K250380) | Surgify Medical OY | 2025-03-13 |
| xvision Spine system (K250255) | Augmedics, Ltd. | 2025-03-13 |
| IceCap product line (K243788) | Bioserenity Medical Devices Group | 2025-03-13 |
| Delphi Amplifier (K243746) | Quantalx Neroscience | 2025-03-12 |
| iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R (K250374) | Stryker Instruments | 2025-03-11 |
| Duet External Drainage and Monitoring System (EDMS) (K243676) | Medtronic Neurosurgery | 2025-03-10 |
| Op.n(TM) Navigation (K242914) | Ecential Robotics | 2025-03-07 |
| EpiWatch Monitoring System (K243515) | Epiwatch, Inc. | 2025-03-07 |
| SPINEART Navigation Instrument System (K242890) | Spineart SA | 2025-03-07 |
| PureLift GLOW (K243587) | Xtreem Pulse, LLC | 2025-03-06 |
| Mako Total Hip Application 5.0 (K243751) | Mako Surgical Corp. | 2025-03-05 |
| pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device (K242676) | Phenox Limited | 2025-02-28 |
| Paradigm System (K243258) | Proprio, Inc. | 2025-02-21 |
| Falcon HST (K242447) | Compumedics Limited | 2025-02-20 |
| Sway System Sports Plus (K241737) | Sway Medical, Inc. | 2025-02-15 |
| ICS Dizcovery (1091) (K242198) | Natus Medical Denmark Aps | 2025-02-14 |
| Ampa One System (AMPA-001) (K243319) | Neuromodulatory Devices & Applications | 2025-02-13 |
| Myolight Microcurrent Handpiece (K243063) | Raja Trading Company, Inc. | 2025-02-10 |
| Delphi MCS Electrode Cap (K243243) | Quantalx Neuroscience, Ltd. | 2025-02-06 |
| Navient Image Guide Navigation System (955-NC-NC), Cranial (K241327) | Claronav | 2025-02-05 |
| JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) (K243393) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-02-03 |
| GYDER® Hip System (K243387) | Gyder Surgical Pty, Ltd. | 2025-01-29 |
| Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT (K243698) | Brainlab AG | 2025-01-28 |
| ClearPoint System (Software Version 3.0) (K243657) | ClearPoint Neuro, Inc. | 2025-01-24 |
| RF Cannula (K241367) | Shanghai Samedical & Plastic Instruments Co., Ltd. | 2025-01-23 |
| Nicolet EDX (K243982) | Natus Neurology Incorporated | 2025-01-22 |
| Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (K242446) | Persyst Development Corporation | 2025-01-22 |
| Geniant Cranial (Navigated Neurosurgical Positioning Robot) (K241333) | Koh Young Technology, Inc. | 2025-01-17 |
| Myocene (DEN230051) | Myocene | 2025-01-17 |
| ADDNOX (BPSPM1) (K243289) | Nu Eyne Co., Ltd. | 2025-01-16 |
| Medi Lift Mask (K244048) | Ya-Man, Ltd. | 2025-01-16 |
| Cala kIQ (K243848) | Cala Health, Inc. | 2025-01-16 |
| Electrode Pad (K241512) | Shenzhen Deliduo Medical Technology Co.,Ltd | 2025-01-15 |
| ARVIS® Shoulder (K243950) | Kico Knee Innovation Company Pty, Ltd. | 2025-01-13 |
| NuVasive Pulse System (K243814) | Globus Medical, Inc. | 2025-01-10 |
| TMINI Miniature Robotic System (K243481) | THINK Surgical, Inc. | 2025-01-06 |
| Synapsys VHIT (K242726) | Inventis S.R.L. | 2025-01-03 |
| Wave Electrode (AE02-60); Wave Electrode (AE02-50) (K242326) | Bionit Labs Srl | 2025-01-02 |
| FLASH EVD System (10-0002) (K242480) | 7D Surgical ULC | 2024-12-27 |
| iovera° System (K243677) | Pacira Biosciences, Inc. | 2024-12-26 |
| SpineAR SNAP (SyncAR Spine) (K243623) | Surgical Theater, Inc. | 2024-12-24 |
| Noxturnal Web (K241288) | Nox Medical Ehf | 2024-12-23 |
| ExcelsiusGPS® Instruments (K243671) | Globus Medical, Inc. | 2024-12-20 |
| Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (K243430) | Shenzhen Aozemei Technology Co., Ltd. | 2024-12-19 |
| Integrity V500 (Integrity, Integrity with VEMP) (K242954) | Vivosonic, Inc. | 2024-12-19 |
| POCKET TENS (EP-300) (K242815) | Hivox Biotek, Inc. | 2024-12-17 |
| XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (K242003) | Aesculap, Inc. | 2024-12-16 |
| CAIs Sensor (CAIs-001) (K241160) | Brainu Co., Ltd. | 2024-12-13 |
| Remex Spine Surgery Navigation Instrument (K243560) | Remex Medical Corp. | 2024-12-13 |
| BTL-785BNF-E (K242532) | BTL Industries, Inc. | 2024-12-13 |
| Natus Ultrapro S100 (982A0594) (K243495) | Natus Neurology Incorporated | 2024-12-12 |
| NExT Station; NExT Station Advanced (K242832) | Eb Neuro S.P.A. | 2024-12-12 |
| Disposable Subdermal Needle Electrode, Corkscrew (K241045) | Technomed Europe | 2024-12-11 |
| HomeSleepTest (HST, HST REM+) (K240700) | Somnomedics GmbH | 2024-12-08 |
| AnyPlus Navigated Instruments System (K243073) | GS Medical Co., Ltd. | 2024-12-06 |
| RelieVRx (K243417) | Appliedvr | 2024-12-04 |
| NeuroMatch (K241390) | LVIS Corporation | 2024-11-26 |
| WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (K240575) | Eemagine Medical Imaging Solutions GmbH | 2024-11-25 |
| Dreem 3S (K242094) | Beacon Biosignals, Inc. | 2024-11-22 |
| Nooro Body & Foot Stimulator (SM9141, SM9142) (K243334) | Xf Agencija Limited | 2024-11-22 |
| Neuvotion NeuStim NN-01 (K240632) | Neuvotion, Inc. | 2024-11-22 |
| Cala kIQ (K242259) | Cala Health, Inc. | 2024-11-22 |
| Natus BrainWatch System (K242930) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-11-19 |
| TMINI Miniature Robotic System (K243285) | THINK Surgical, Inc. | 2024-11-15 |
| SmartFlow Neuro Cannula (DEN240023) | ClearPoint Neuro, Inc. | 2024-11-13 |
| Mako Shoulder Application (1.0) (K242373) | Mako Surgical Corp. | 2024-11-07 |
| ELEXIR 2.0 (ALLIVE3) (K242719) | Nu Eyne Co., Ltd. | 2024-11-06 |
| Delphi Stimulator (K242345) | Quantalx Neuroscience | 2024-11-05 |
| Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494) (K242332) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2024-11-05 |
| Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) (K242567) | Changsha Anxiang Medical Technology Co., Ltd. | 2024-11-04 |
| Caduceus S (K242271) | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2024-10-30 |
| AtriCure cryoICE BOX (ACM) (K243157) | AtriCure, Inc. | 2024-10-29 |
| Duet External Drainage and Monitoring System (EDMS) (K242034) | Medtronic Neurosurgery | 2024-10-24 |
| Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator (K233054) | Well-Life Healthcare Limited | 2024-10-18 |
| ROSA® Knee System (K242864) | Orthosoft Inc. (d/b/a) Zimmer CAS | 2024-10-18 |
| REMI-AI Rapid Detection Module (REMI-AI RDM) (K240408) | Epitel, Inc. | 2024-10-17 |
| EGPS Navigated Instruments (K240160) | Astura Medical | 2024-10-17 |
| xvision Spine System (K241481) | Augmedics, Ltd. | 2024-10-16 |
| QUEX ED; QUEX S (K232779) | Qx World, Ltd. | 2024-10-11 |
| Nerivio; NerivioInfinity (K241756) | Theranica Bio-Electronics, Ltd. | 2024-10-08 |
| Zeta Cranial Navigation System (ZNS131-US) (K242351) | Zeta Surgical, Inc. | 2024-10-04 |
| QUADSENSE (K241298) | Eventum Orthopaedics, Ltd. | 2024-10-04 |
| Lantern® Hip (K242616) | Orthalign, Inc. | 2024-10-03 |
| Numen™ Coil Embolization System; NumenFR™ Detachment System (K242154) | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-09-30 |
| Optima Coil System (OptiBlock Line Extension) (K242582) | Balt USA, LLC | 2024-09-27 |
| Sourcerer (K241513) | Brain Electrophysiology Laboratory Company, LLC | 2024-09-27 |