| encevis (2.1) (K240993) | Ait Austrian Institute of Technology GmbH | 2024-09-27 |
| Permatage Settable Bone Putty (K241027) | Orthocon, Inc. | 2024-09-26 |
| Traus SSG10 Surgical System (K233153) | Saeshin Precision Co., Ltd. | 2024-09-20 |
| NeuroField Analysis Suite (K240420) | Neurofield, Inc. | 2024-09-20 |
| CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (K241893) | Medos International SARL | 2024-09-16 |
| Traus SSG30 Surgical System (K232938) | Saeshin Precision Co., Ltd. | 2024-09-16 |
| TENS & EMS Stimulator (MHD-1083) (K241678) | Shenzhen Minghuangda Electronics Co., Ltd. | 2024-09-09 |
| BE Plus PRO, Neurotravel LIGHT (K242305) | Eb Neuro S.P.A. | 2024-09-04 |
| DreamClear (K240646) | Somnomed Technologies Inc., Doing Business AS Remware | 2024-09-04 |
| SignalNED System (Model RE) (K242306) | Forest Devices, Inc. | 2024-09-04 |
| Talee, Talee PostOp (K241957) | Invent Medical USA, LLC | 2024-08-30 |
| Daylight (K233872) | Big Health, Inc. | 2024-08-30 |
| 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) (K241518) | The Magstim Company Limited | 2024-08-30 |
| Unipro (K-UNIPRO-US) (K232441) | Tenscare, Ltd. | 2024-08-30 |
| Target Detachable Coils (K242243) | Stryker Neurovscular | 2024-08-29 |
| Grass® MR Conditional/CT Cup Electrodes (K242346) | Natus Manufacturing Limited | 2024-08-29 |
| BT-1000 (K232991) | Bistos Co., Ltd. | 2024-08-28 |
| TENSWave (K241228) | Zynex Medical Officer | 2024-08-27 |
| Q Guidance System; Mako Spine System; (K241517) | Stryker Leibinger GmbH & Co KG | 2024-08-27 |
| TMINI Miniature Robotic System (K242264) | THINK Surgical, Inc. | 2024-08-23 |
| VEEGix EEG System (K240593) | NeuroServo, Inc. | 2024-08-23 |
| Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation (K233801) | Boston Scientific Neuromodulation | 2024-08-23 |
| cCeLL - In vivo (K233391) | VPIX Medical, Inc. | 2024-08-21 |
| Nalu Neurostimulation System for Peripheral Nerve Stimulation (K232415) | Boston Scientific Neuromodulation | 2024-08-21 |
| Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (K241458) | Borvo Medical, Inc. | 2024-08-20 |
| OnPoint Augmented Reality Spine System (K241870) | Onpoint Surgical, Inc. | 2024-08-19 |
| COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) (K242057) | Avanos Medical, Inc. | 2024-08-14 |
| Pixie Pulse (SM9068) (K241365) | Pixie Cup, LLC | 2024-08-12 |
| 360CAS Knee (K242009) | Kico Knee Innovation Company Pty, Ltd. | 2024-08-08 |
| HipXpert and HipInsight System (K233315) | Surgical Planning Associates, Inc. | 2024-08-08 |
| SPINEART Navigation Instrument System (K241644) | Spineart SA | 2024-08-07 |
| Sleepio® (K233577) | Big Health, Inc. | 2024-08-05 |
| Bendini Cloud Application (K233706) | Nuvasive | 2024-08-02 |
| A Breathing System (ABS) (K233580) | Deepwell Dtx, Inc. | 2024-08-01 |
| Spine Navigation System (K233725) | Medivis, Inc. | 2024-07-26 |
| DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) (K241883) | Pro Med Instruments GmbH | 2024-07-26 |
| Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories (K241171) | Stryker Leibinger GmbH & Co KG | 2024-07-25 |
| “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) (K241130) | Point Robotics MedTech, Inc. | 2024-07-24 |
| Transcutaneous Electrical Nerve Stimulator (K6106) (K241119) | Shenzhen Yicai Health Technology Co., Ltd. | 2024-07-22 |
| Wireless TENS & EMS (Model SM9110,SM9113,SM9116) (K233067) | Chongqing Rob Linka Science and Technology Co., Ltd. | 2024-07-19 |
| B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (K240821) | Braincare Desenvolvimento E Inovação Tecnológica S.A. | 2024-07-18 |
| CEFALY Connected - OTC, CEFALY Connected - Rx (K234029) | Cefaly Technology | 2024-07-18 |
| allay Nerve Cap (DEN230061) | Tulavi Therapeutics | 2024-07-16 |
| TMINI Miniature Robotic System (TMINI 1.1) (K241031) | THINK Surgical, Inc. | 2024-07-12 |
| Anatase Navi Disposable Instrument (K241625) | Remex Medical Corp. | 2024-07-05 |
| BLUE 400; BLUE 400 S (K240215) | Carl Zeiss Meditec, AG | 2024-06-28 |
| NuFACE® FIX+ (K240564) | Carol Cole Company Dba Nuface® | 2024-06-27 |
| TENS&EMS units (SM9109A, SM9109B) (K241509) | Plexus Yoga, LLC Dba Chirp | 2024-06-27 |
| MyndMove, MyndMove 2.0 (K233006) | Myndtec, Inc. | 2024-06-25 |
| Mochida Nerve Cuff (K233322) | Mochida Pharmaceutical Co., Ltd. | 2024-06-21 |
| Freedom Peripheral Nerve Stimulator (PNS) System (K233162) | Curonix | 2024-06-20 |
| VERABAND™ (K233987) | Arbor Medical Innovations, LLC | 2024-06-17 |
| Robotic Integration Instruments (K233256) | DePuy Synthes | 2024-06-17 |
| CROSSNAV Navigation Enabled Instruments (K233255) | DePuy Synthes | 2024-06-17 |
| ExcelsiusFlex™ (K240721) | Globus Medical, Inc. | 2024-06-14 |
| TELIGEN System Navigation Ready Instruments (K233254) | DePuy Synthes | 2024-06-14 |
| INNOVERSE Navigation Instruments (K241082) | Innosys Co., Ltd. | 2024-06-14 |
| Spine Navigation and Robotic-Assistance Device (K233228) | Ecential Robotics | 2024-06-14 |
| Mako Total Knee Application (K241011) | Mako Surgical Corp. | 2024-06-11 |
| DOOPANG (K232749) | Ybrain, Inc. | 2024-06-11 |
| Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01) (K240108) | Gymmax Technology Shenzhen Co., Ltd. | 2024-06-10 |
| Invictus Robotic Navigation Instruments (K240951) | Alphatec Spine | 2024-06-06 |
| Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece (K240662) | Stryker Leibinger GmbH & Co KG | 2024-06-06 |
| VELYS Robotic-Assisted Solution (K240211) | Depuy Ireland UC | 2024-06-05 |
| Milieve (YPS-301BD) (K233751) | Soterix Medical, Inc. | 2024-06-03 |
| Deep TMS System (K222196) | Brainsway , Ltd. | 2024-05-31 |
| NET Recovery Corp/NET Device (K233166) | Net Recovery | 2024-05-29 |
| Apollo TMS Therapy System (K232639) | Mag & More GmbH | 2024-05-24 |
| Racz Neurostat RF Generator (K232632) | Epimed International | 2024-05-24 |
| Drill Guide; Drill Bit; Spine & Trauma Navigation (K240701) | Brainlab AG | 2024-05-23 |
| TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) (K233985) | Megin OY | 2024-05-15 |
| BEAR 2 Body (K232242) | Foreo, Inc. | 2024-05-13 |
| CORUS Navigation Access System (K240625) | Providence Medical Technology, Inc. | 2024-05-03 |
| Remex Spine Surgery Navigation System II (K233513) | Remex Medical Corp. | 2024-05-01 |
| Flexset System (K233403) | Zeto, Inc. | 2024-04-30 |
| DuraPro™ Oscillating System (K240568) | Globus Medical, Inc. | 2024-04-29 |
| ARVIS® Shoulder (K240062) | Insight Medical Systems, Inc. | 2024-04-29 |
| Bone Anchor (NGS-BA-01) (K233703) | ClearPoint Neuro, Inc. | 2024-04-26 |
| DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) (K240319) | Pro Med Instruments GmbH | 2024-04-24 |
| NextAR™ Spine Platform (K233172) | Medacta International S.A. | 2024-04-24 |
| MamaLift Plus (K223515) | Curio Digital Therapeutics, Inc. | 2024-04-22 |
| SafeOp 3: Neural Informatix Systeem (K234092) | Alphatec Spine, Inc. | 2024-04-19 |
| Electrical Neuromuscular Stimulator, Cure Trio (K233046) | Oriental Inspiration Limited | 2024-04-19 |
| Glide (91000-GL-X) (K240884) | Infinite Biomedical Technologies, LLC | 2024-04-15 |
| Virage® Navigation System (K240647) | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2024-04-05 |
| VSP PEEK Cranial Implant (K231834) | 3D Systems, Inc. | 2024-04-04 |
| Oxevision Sleep Device (K233618) | Oxehealth Limited | 2024-04-03 |
| Rejoyn (K231209) | Otsuka America Pharmaceutical, Inc. | 2024-03-30 |
| Genesys Spine Sacroiliac Joint Fusion System with Navigation (K233595) | Genesys Spine | 2024-03-29 |
| CustomizedBone Service (K240567) | Fin-Ceramica Faenza S.P.A. | 2024-03-28 |
| Modius Stress (K232253) | Neurovalens Limited | 2024-03-27 |
| Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) (K231425) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2024-03-27 |
| Transcutaneous Electrical Nerve Stimulator (9029SCM) (K240292) | Hong Kong Etech Groups Limited | 2024-03-25 |
| MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (K234080) | Soterix Medical, Inc. | 2024-03-25 |
| NeuroStar Advanced Therapy System (All previously cleared models) (K231926) | Neuronetics, Inc. | 2024-03-22 |
| Electrical Stimulator System (K232439) | Gymmax Technology Shenzen Co., Ltd. | 2024-03-21 |
| Automatic Registration (K234047) | Brainlab AG | 2024-03-20 |
| Amydi-med Disposable Non-invasive EEG electrodes (K240668) | Shenzhen Amydi-Med Electrics Tech Co., Ltd. | 2024-03-19 |
| Real Intelligence™ CORI™ (K240139) | Blue Belt Technologies, Inc. | 2024-03-18 |
| STARband 3D (K240466) | Orthomerica Products, Inc. | 2024-03-15 |