| Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 (K172440) | Dongguan Prestige Sporting Goods., Ltd. | 2018-07-13 |
| Tinnitus Sound Generator Module (K181586) | GN Hearing A/S | 2018-07-13 |
| Injection Screw (K173556) | Biedermann Medtech, Inc. | 2018-07-13 |
| Normandy VBR System (K180673) | Zavation Medical Products, LLC | 2018-07-13 |
| G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray (K181134) | Sunstar Americas, Inc. | 2018-07-13 |
| Viking Lumbar Polyaxial Screw System (K180655) | Presidio Surgical | 2018-07-13 |
| IRRAflow CNS System (K171880) | Irras, Inc. | 2018-07-13 |
| Pulmonx Chartis Tablet Console (K180011) | Pulmonx Corporation | 2018-07-13 |
| PINXEL-RF system (K180654) | Rohrer Aesthetics, LLC | 2018-07-13 |
| Dimension Hemoglobin A1c Assay (K173909) | Siemens Healthcare Diagnostics, Inc. | 2018-07-13 |
| THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X (K180575) | Olympus Medical Systems Corp. | 2018-07-12 |
| CONOD Enteral Feeding Sets (K181276) | Conod Medical Co., Limited | 2018-07-12 |
| StatStrip Glucose Hospital Meter System (K181043) | Nova Biomedical Corporation | 2018-07-12 |
| ADVIA Centaur High-Sensitivity Troponin I (TNIH) (K171274) | Siemens Healthcare Diagnostics, Inc. | 2018-07-12 |
| FBC 921 (ALIF) (K180695) | Fbc Device Aps | 2018-07-12 |
| Modified Novy Cornual Cannulation Set (K180552) | Cook Incorporated | 2018-07-12 |
| Catalyst CSR Shoulder System (K181287) | Catalyst Orthoscience, Inc. | 2018-07-12 |
| Infrared Thermometer (K172874) | Shenzhen Jiacom Technology CO ., Ltd. | 2018-07-12 |
| ActiveCare TD-4121 Blood Glucose Monitoring System (K173511) | Taidoc Technology Corporation | 2018-07-12 |
| AIM2 (K181011) | GC America, Inc. | 2018-07-12 |
| SEKURE HbA1c Assay (K173206) | Sekisui Diagnostics P.E.I., Inc. | 2018-07-12 |
| Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (K173627) | Surgical Instrument Service and Savings, Inc. | 2018-07-12 |
| Estelite Universal Flow (K180613) | Tokuyama Dental Corporation | 2018-07-12 |
| Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G (K173881) | Owen Mumford, Ltd. | 2018-07-11 |
| INVISION Total Ankle Revision System (K180730) | Wrightmedicaltechnologyinc | 2018-07-11 |
| Medicalgorithmics Unified Cardiac Rehabilitation System (K173969) | Medicalgorithmics S.A. | 2018-07-11 |
| Aspire Introducer Needle (K180725) | Aspire Bariatrics, Inc. | 2018-07-11 |
| Intelli-C (K173631) | Nrt X-Ray A/S | 2018-07-11 |
| Dental Diode Laser System (K180967) | Lazon Medical Laser Co., Ltd. | 2018-07-11 |
| Syneron CO2RE System (K181523) | Syneron-Candela Corp | 2018-07-11 |
| 16ch Foot/ Ankle SPEEDER (K181697) | Quality Electrodynamics, LLC | 2018-07-11 |
| High-speed Turbine Handpieces for Single Use (K172543) | Beijing Dongbo Dental Handpiece Co., Ltd. | 2018-07-11 |
| NTU-USB Ultrasound USB Box (K173486) | National Taiwan University | 2018-07-11 |
| Ziehm RFD 3D Tracker (K180816) | Medtronic Navigation | 2018-07-11 |
| SALVATION Midfoot Nail (K180024) | Wrightmedicaltechnologyinc | 2018-07-11 |
| ROCCIA ALIF, ROCCIA TLIF (K180963) | Silony Medical GmbH | 2018-07-11 |
| Infrared Thermometer (K180314) | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2018-07-11 |
| Transcranial Doppler Ultrasound System (K173801) | Shenzhen Delica Medical Equipment Co., Ltd. | 2018-07-11 |
| Advanced Dental Applicance (K172991) | Dasoft Partners | 2018-07-10 |
| Zavation IBF System (K181246) | Zavation Medical Products, LLC | 2018-07-10 |
| Uscan (K181574) | EchoNous, Inc. | 2018-07-10 |
| Ceevra Reveal 2.0 (K173274) | Ceevra, Inc. | 2018-07-10 |
| LED Light Therapy Device (K180900) | Uvbiotek, LLC | 2018-07-10 |
| Synermed ISE Reagents (K181201) | Infrared Laboratory Systems, LLC (Dba Synermed) | 2018-07-10 |
| Zavation Cervical Plate System (K181244) | Zavation Medical Products, LLC | 2018-07-10 |
| TruMatch CMF Titanium 3D Printed Implant (K173039) | Materialise NV | 2018-07-10 |
| Pseudo-Patient (K180697) | Rtsafe, Inc. | 2018-07-10 |
| HardyDisk AST Plazomicin 30ug (PLZ30) (K181700) | Hardy Diagnostics | 2018-07-10 |
| Workflow Box (K181572) | Mirada Medical, Ltd. | 2018-07-10 |
| Disposable guides KDNG00 (K180970) | Koelis | 2018-07-10 |
| 3D Bolus Software (K180289) | 3D Bolus, Inc. | 2018-07-10 |
| Curiteva Cervical Interbody Fusion System (K181261) | Curiteva, LLC | 2018-07-09 |
| Personal Lubricating Jelly (K180923) | Perrigo New York, Inc. | 2018-07-09 |
| Prime Acetabular Cup System (K180798) | Microport Orthopedics, Inc. | 2018-07-09 |
| Straumann Jason Membrane (K173562) | Institut Straumann AG | 2018-07-09 |
| FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) (K181547) | Echosens | 2018-07-09 |
| EMPOWR VVC TIBIAL INSERT (K180930) | Encore Medical L.P. | 2018-07-09 |
| PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope (K181522) | Pentax of America, Inc. | 2018-07-09 |
| BMLS16-1 (K172971) | Biomedical Life Systems, Inc. | 2018-07-08 |
| PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs (K173766) | Shen Wei USA, Inc. | 2018-07-08 |
| Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set (K180868) | Cook Ireland | 2018-07-06 |
| Materialise PKA Guide System (K173970) | Materialise NV | 2018-07-06 |
| DRI Cocaine Metabolite Assay (K181499) | Microgenics Corporation | 2018-07-06 |
| GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar (K173019) | ETHICON, Inc. | 2018-07-06 |
| ASTRA-OCT Spine System (K181350) | Spinecraft, LLC | 2018-07-06 |
| InPen Dose Calculator (K181327) | Companion Medical, Inc. | 2018-07-06 |
| Vail ALIF Buttress Plate System (K180755) | Evolution Spine, LLC | 2018-07-06 |
| Tyber Medical PT Interbody Spacer System (K180590) | Tyber Medical, LLC | 2018-07-06 |
| Howell D.A.S.H Extraction Balloon with Multiple Sizing (K173659) | Wilson-Cook Medical, Inc. | 2018-07-06 |
| Elecsys BRAHMS PCT (K173927) | Roche Diagnostics | 2018-07-06 |
| OLYMPIC Posterior Spinal Fixation System (K181139) | Astura Medical, LLC | 2018-07-06 |
| Sterile Disposable Syringes (K172694) | Shenyang Mastech Medical Device Co., Ltd. | 2018-07-06 |
| GammaTile (K180515) | Isoray Medical, Inc. | 2018-07-06 |
| CHROMID CARBA agar (CARB) (K181092) | Biomerieux S.A. | 2018-07-06 |
| BIOLOX delta Option and Extra-long Heads (K173776) | Microport Orthopedics, Inc. | 2018-07-06 |
| Endorate Valve Sets (K181509) | Smartdata Suzhou Co., Ltd. | 2018-07-06 |
| CheckMyHeart Plus (K172778) | Dailycare Biomedical, Inc. | 2018-07-05 |
| FilmArray Blood Culture Identification (BCID) Panel (K181493) | Biofire Diagnostics, LLC | 2018-07-05 |
| Fractional CO2 Surgical Laser System (K173359) | Ami, Inc. | 2018-07-05 |
| Nitrile Patient Examination Powder Free Glove, Textured, Black (K161085) | Multisafe Sdn. Bhd. | 2018-07-05 |
| SureForm 60 and SureForm 60 Reloads (K173721) | Intuitive Surgical | 2018-07-05 |
| 12F Tri-Flow Triple Lumen Catheter (K181175) | Medical Components, Inc. (dba MedComp) | 2018-07-05 |
| ASAHI PTCA Guide Wire ASAHI SION black (K173277) | Asahi Intecc Co., Ltd. | 2018-07-05 |
| Disposable Hot Biopsy Forceps (K180018) | Micro-Tech (Nanjing) Co., Ltd. | 2018-07-05 |
| 400um Perforator and Accessory Vein Ablation Kit (K181044) | AngioDynamics, Inc. | 2018-07-05 |
| Riptide Aspiration System React 68 Catheter (K180705) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-07-04 |
| React 68 Catheter (K180715) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-07-04 |
| XRpad2 4343 HWC-M Flat Panel Detector (K181526) | Varex Imaging Corporation | 2018-07-03 |
| Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit (K172952) | Figaro Crowns, Inc. | 2018-07-03 |
| PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (K173679) | Pentax of America, Inc. | 2018-07-03 |
| PeriView FLEX (K181193) | Olympus Surgical Technologies America | 2018-07-03 |
| ETEST Telavancin (TLA) (0.002-32 ug/mL) (K180936) | Biomerieux S.A. | 2018-07-03 |
| Ureterorenoscope System (K180367) | Shanghai AnQing Medical Instrument Co., Ltd. | 2018-07-03 |
| Serenity Body Position Sensor, Serenity RIP Sensors (K173868) | Neurotronics, Inc. | 2018-07-02 |
| Peekplus® Interbody Fusion Device (K173864) | Vallum Corporation | 2018-07-02 |
| ULTRAPRO Mesh and ULTRAPRO ADVANCED (K180910) | ETHICON, Inc. | 2018-07-02 |
| Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP (K173276) | Medline Industries, Inc. | 2018-07-02 |
| qEEG-Pro (K171414) | Brainmaster Technologies, Inc. | 2018-07-01 |
| Zuga Dental Implant System (K171197) | Zuga Medical, Inc. | 2018-06-30 |
| Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (K181232) | Largan Medical Co., Ltd. | 2018-06-29 |