| Neck Care Therapy, Model: SYK 509B (K172897) | Shenzhen Osto Technology Co., Ltd. | 2018-12-07 |
| Spartan eCoil System (K180653) | Spartan Micro, Inc. | 2018-12-04 |
| Espire Elbow Pro, Espire Elbow Hybrid (K182757) | College Park Industries, Inc. | 2018-11-29 |
| Persyst 14 EEG Review and Analysis Software (K182181) | Persyst Development Corporation | 2018-11-29 |
| gammaCore Sapphire (K182369) | Electrocore, Inc. | 2018-11-27 |
| Low-frequency Multi-function physiotherapy instrument (K172837) | Shenzhen Osto Technology Co., Ltd. | 2018-11-26 |
| PlayMakar Sport Muscle Stimulator, Model PRO-500 (K182581) | Playmakar, Inc. | 2018-11-21 |
| MR Compatible Aspiration Kit (K181731) | Mri Interventions, Inc. | 2018-11-20 |
| CodMan Certas Plus Programmable Valve (K182265) | Integra Lifesciences Corp. | 2018-11-20 |
| Serenity Piezo Sensor, Serenity Thermocouple Sensor (K181709) | Neurotronics, Inc. | 2018-11-16 |
| Heat Pain Pro (K181992) | Omron Healthcare, Inc. | 2018-11-09 |
| AtriCure cryoICE cryoSPHERE cryoablation probe (K182565) | AtriCure, Inc. | 2018-11-09 |
| Brainlab Compatible K2M Navigation Instruments (K181890) | K2m | 2018-11-09 |
| ELAN 4 Air Motor System (K172907) | Aesculap, Inc. | 2018-11-09 |
| Steribite (K180949) | Rjr Surgical, Inc. | 2018-11-08 |
| Universal Mesh - Sterile (K182425) | Stryker Leibinger GmbH & Co KG | 2018-11-06 |
| Mazor X System (Mazor X Stealth Edition) (K182077) | Mazor Robotics , Ltd. | 2018-11-02 |
| ClearPoint System (K181195) | Mri Interventions, Inc. | 2018-11-02 |
| NavLock Trackers, Robotic Reference Frame (K182104) | Medtronic Navigation | 2018-11-02 |
| CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition (K182121) | Medtronic Sofamor Danek USA, Inc. | 2018-11-02 |
| DAEHAN Adhesive Surface Electrodes (K180247) | Daehan Medical Systems Co., Ltd. | 2018-11-01 |
| V2 OTC Pain Relief TENS (K182767) | Everyway Medical Instruments Co.,Ltd | 2018-10-26 |
| A6 OTC Pain Relief TENS (K182753) | Everyway Medical Instruments Co.,Ltd | 2018-10-26 |
| CONVIVO (K181116) | Carl Zeiss Meditec, AG | 2018-10-25 |
| External upper limb tremor stimulator (K182706) | Cala Health, Inc. | 2018-10-25 |
| Codman Certas Plus Electronic Tool Kit (K181902) | Integra Lifesciences Corp. | 2018-10-25 |
| Solitare Platinum Revascularization Device (K181186) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-10-25 |
| Spine Wave Navigated Instruments (K181596) | Spine Wave, Inc. | 2018-10-24 |
| ImPACT (K181223) | Impact Applications, Inc. | 2018-10-20 |
| ELAN 4 Electro Motor System Tools (K172709) | Aesculap, Inc. | 2018-10-17 |
| KidCap (K180568) | Eastern Cranial Affiliates, LLC | 2018-10-16 |
| OSSDSIGN Cranioplug (K181539) | Ossdsign AB | 2018-10-12 |
| ADAPT for Gamma3, Gamma3 (K181848) | Stryker GmbH | 2018-10-12 |
| NuFACE Trinity (K181008) | Carol Cole Company Dba Nuface | 2018-10-11 |
| Sense System with IBT Electrodes (K182112) | Infinite Biomedical Technologies, LLC | 2018-10-05 |
| POWEREASE System (K182436) | Medtronic Sofamor Danek USA, Inc. | 2018-10-04 |
| StrataMR guider tool (K181622) | Medtronic Neurosurgery | 2018-10-01 |
| RightEye Vision System (K181771) | Righteye, LLC | 2018-09-28 |
| Everyway Wireless TENS & EMS Unit (K181707) | Everyway Medical Instruments Co.,Ltd | 2018-09-26 |
| Spineology Navigation Instruments (K182345) | Spineology, Inc. | 2018-09-21 |
| Ortoma Treatment Solution - OTS (K181449) | Ortoma AB | 2018-09-19 |
| Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit (K180981) | Stimwave Technologies Incorporated | 2018-09-19 |
| ThermaCare Quick Therapy TENS (K181102) | Pfizer, Inc. | 2018-09-15 |
| DizzyDoctor System 1.0.0 (K182214) | Dizzydoctor Systems, LLC | 2018-09-14 |
| Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) (K180369) | Relievant Medsystems | 2018-09-14 |
| TENS device-HeadaTerm, eEspress (K172450) | Wat Medical Technology (Ningbo) Co., Ltd. | 2018-09-13 |
| Dual output digital therapy massager (K172834) | Shenzhen Osto Technology Co., Ltd. | 2018-09-06 |
| Cadwell Zenith System (K181466) | Cadwell Industries, Inc. | 2018-09-01 |
| Geister retractor for neuro - and spine surgery (K180610) | Geister Medizin Technik GmbH | 2018-08-29 |
| Solitaire 2 and Solitaire Platinum Revascularization Device (K181060) | Medtronic Neurovascular | 2018-08-24 |
| Freespira (K180173) | Palo Alto Health Sciences, Inc. | 2018-08-23 |
| Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System (DEN170078) | Brainways , Ltd. | 2018-08-17 |
| BioWaveGO (K180943) | Biowave Corporation | 2018-08-17 |
| Mag Vita TMS Therapy System w/Theta Burst Stimulation (K173620) | Tonica Elektronik A/S | 2018-08-14 |
| iStim S2 OTC Pain Relief TENS (K181849) | Everyway Medical Instruments Co., Ldt. | 2018-08-10 |
| Anchor Bolt (as an accessory to Depth Electrodes) (K181544) | Ad-Tech Medical Instrument Corporation | 2018-08-09 |
| 7D Surgical System Cranial Application (K181041) | 7D Surgical, Inc. | 2018-08-08 |
| Self-adhesive Electrode (K181234) | Dong Guan OU Kang Electronics Co., Ltd. | 2018-08-07 |
| HORIZON TMS Therapy System (K180907) | Magstim Company, Ltd. | 2018-08-03 |
| SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit (K181422) | Spr Therapeutics, Inc. | 2018-07-31 |
| OsteoFab Patient Specific Cranial Device (K180064) | Oxford Performance Materials, Inc. | 2018-07-27 |
| neuromate Gen III (K181706) | Renishaw Mayfield Sarl | 2018-07-26 |
| I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System (K181025) | Neuro Kinetics, Inc. | 2018-07-24 |
| Voyager Trajectory Array Guide (V-TAG) (K180854) | Voyager Therapeutics, Inc. | 2018-07-23 |
| TruDi NAV Suction Instruments (K180948) | Acclarent, Inc. | 2018-07-20 |
| GuardianTM Burr Hole Cover System (K181382) | St Jude Medical | 2018-07-20 |
| NicoletOne (K173366) | Natus Neurology Incorporated | 2018-07-20 |
| Ultra Facial Toning System (K181062) | Micro Current Technology, Inc. | 2018-07-18 |
| Cadwell Apollo System (K180269) | Cadwell Industries, Inc. | 2018-07-17 |
| IRRAflow CNS System (K171880) | Irras, Inc. | 2018-07-13 |
| Ziehm RFD 3D Tracker (K180816) | Medtronic Navigation | 2018-07-11 |
| BMLS16-1 (K172971) | Biomedical Life Systems, Inc. | 2018-07-08 |
| Serenity Body Position Sensor, Serenity RIP Sensors (K173868) | Neurotronics, Inc. | 2018-07-02 |
| qEEG-Pro (K171414) | Brainmaster Technologies, Inc. | 2018-07-01 |
| NuVasive Pulse System (K180038) | Nu Vasive, Incorporated | 2018-06-29 |
| ZMI Self-Adhesive Electrodes (K180865) | Zmi Electronics , Ltd. | 2018-06-28 |
| Navigation Instruments (K180690) | Globus Medical, Inc. | 2018-06-25 |
| OSSEODUO Shaver and Drill System (K173066) | Bien-Air Surgery SA | 2018-06-22 |
| Wireless Pain Relieve Device (K180331) | Shenzhen Dongdixin Technology Co., Ltd. | 2018-06-22 |
| SD LTM STIM Cortical Stimulator (K180761) | Micromed S.P.A. | 2018-06-18 |
| Natus Photic Stimulator (K173936) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-15 |
| Smart External Drain (SED) System (K181301) | Aqueduct Critical Care, Inc. | 2018-06-14 |
| Natus Brain Monitor Amplifier (K180290) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-14 |
| VERASENSE for Zimmer Biomet Persona (K180459) | Orthosensor, Inc. | 2018-06-07 |
| Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator (K180956) | Shenzhen Roundwhale Technology Co. , Ltd. | 2018-06-07 |
| Balego TENS Digital Edition with Accessories for Pain Relief (OTC) (K181207) | Everyway Medical Instruments Co., Ldt. | 2018-06-06 |
| TAMA BEMS device (K173093) | Tama Research Corporation | 2018-06-05 |
| Silverwear Silver Pro Garment Device (K171798) | Media Plus, LLC | 2018-06-01 |
| ActiGraph CentrePoint Insight Watch (K181077) | Actigraph | 2018-05-24 |
| Reusable and Self-Adhesive Electrodes (K180773) | Shaoxing Dongzhi Electrical Technology Co., Ltd. | 2018-05-22 |
| Cellvizio 100 Series Systems with Confocal Miniprobes (K180270) | Mauna Kea Technologies | 2018-05-22 |
| EEG-Now (K180524) | Encephalodynamics, Inc. | 2018-05-18 |
| BrainScope One (K181179) | Brainscope Company, Inc. | 2018-05-18 |
| AURA ICP MONITORING SYSTEM (K172209) | Branchpoint Technologies, Inc. | 2018-05-18 |
| Navigated INFINITY Instruments (K181111) | Medtronic Sofamor Danek USA, Inc. | 2018-05-17 |
| CustomizedBone Service (K180513) | Fin-Ceramica Faenza S.P.A. | 2018-05-15 |
| SeaSpine Navigation System (K172517) | SeaSpine Orthopedics Corporation | 2018-05-11 |
| g.Estim PRO (K173684) | G.Tec Medical Engineering GmbH | 2018-05-04 |
| Apollo TMS Therapy System (K180313) | Mag & More GmbH | 2018-05-04 |
| Trackit T4 EEG Amplifier (K172271) | Lifelines , Ltd. | 2018-05-04 |