| Upcera Glaze Paste, Glaze Powder, and Glaze Liquid (K181167) | Liaoning Upcera Co., Ltd. | 2018-09-02 |
| Cadwell Zenith System (K181466) | Cadwell Industries, Inc. | 2018-09-01 |
| AmCAD-UT Detection 2.2 (K180006) | Amcad Biomed Corporation | 2018-08-31 |
| CarriGen PF (K182107) | Etex Corporation | 2018-08-31 |
| LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (K181464) | DiaSorin, Inc. | 2018-08-31 |
| myTAP2 (K181482) | Airway Management, Inc. | 2018-08-31 |
| BIO-C REPAIR (K180185) | Angelus Industria DE Produtos Odontologicos S/A | 2018-08-31 |
| CareSens S Fit Blood Glucose Monitoring System (K180866) | I-Sens, Inc. | 2018-08-31 |
| ALTAPORE (K181225) | Baxter Healthcare Corporation | 2018-08-31 |
| IlluminOss Bone Stabilization System (K181228) | Illuminoss Medical, Inc. | 2018-08-31 |
| Reusable & Disposable SpO2 Sensors (K173368) | Shenzhen Coreray Technology, Ltd. | 2018-08-31 |
| Intelligent Mesh Nebulizer (K171549) | Qingdao Future Medical Technology Co., Ltd. | 2018-08-31 |
| ChemoCLAVE Cytotoxic Medication Preparation and Delivery System (K173477) | Icu Medical, Inc. | 2018-08-31 |
| Cure™ OPEL-C Plate System (K181543) | Meditech Spine, LLC | 2018-08-31 |
| Sofia 2 Lyme FIA, Sofia Lyme Control Set (K173496) | Quidel Corporation | 2018-08-30 |
| DEKA Motus AY (K181486) | El.En Electronic Engineering Spa | 2018-08-30 |
| SpineJack Expansion Kit (K181262) | Vexim SA | 2018-08-30 |
| Anchor plate (K173623) | Biomaterials Korea, Inc. | 2018-08-30 |
| Dissecting Balloon System (K182024) | Applied Medical Resources Corp. | 2018-08-30 |
| Arthrex PushLock Tenodesis Anchor (K181513) | Arthrex, Inc. | 2018-08-30 |
| Spectralis HRA + OCT and variants (K173648) | Heidelberg Engineering GmbH | 2018-08-30 |
| Neodent Implant System – GM Line (K180536) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018-08-30 |
| Swiss LithoClast Trilogy (K181997) | E.M.S Electro Medical Systems S.A | 2018-08-30 |
| LYFT (K180888) | Uplevity, Inc. | 2018-08-30 |
| b-ONE® Total Hip System (K173380) | B-One Ortho, Corp. | 2018-08-30 |
| Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 (K173042) | Edan Instruments, Inc. | 2018-08-30 |
| ACCUFUSE Cervical System (K181471) | Absolute Advantage Medical, LLC | 2018-08-29 |
| ResCUBE™ Ligament Fixation System (K181799) | Cousin Biotech Sas | 2018-08-29 |
| Genesys Spine AIS-C Cervical Stand-Alone System (K181295) | Genesys Spine | 2018-08-29 |
| Change Healthcare Enterprise Viewer (K181185) | Change Healthcare Canada Company | 2018-08-29 |
| ZELTIQ CoolSculpting System (K181740) | Zeltiq Aesthetics, Inc. | 2018-08-29 |
| Meta P&Bond (K180802) | Meta Biomed Co., Ltd. | 2018-08-29 |
| Geister retractor for neuro - and spine surgery (K180610) | Geister Medizin Technik GmbH | 2018-08-29 |
| Equinox Advantage (K173205) | O-Two Medical Technologies, Inc. | 2018-08-29 |
| Natrelle 133S Tissue Expander (K182054) | Allergan | 2018-08-29 |
| Zio AT ECG Monitoring System, ZEUS System (K181502) | iRhythm Technologies, Inc. | 2018-08-29 |
| CD HORIZON™ Spinal System (K182119) | Medtronic Sofamor Danek USA, Inc. | 2018-08-29 |
| REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (K172906) | Osteoremedies, LLC | 2018-08-29 |
| Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set (K180073) | Shenzhen Vitavitro Bio-Tech Co., Ltd. | 2018-08-29 |
| TruClear Elite Hysteroscope (K180496) | Covidien | 2018-08-29 |
| Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style (K181104) | Shenzhen Combei Technology Co., Ltd. | 2018-08-29 |
| Tenex Health TX System with the TXP MicroTip (K181367) | Tenex Health, Inc. | 2018-08-28 |
| Disposable Insulin Pen Needle (K181069) | Zhejiang Kindly Medical Devices Co., Ltd. | 2018-08-28 |
| Universal SmartECG (K173952) | Vectracor, Inc. | 2018-08-28 |
| BD MAX CT/GC/TV 20-Day QC Panel (K181683) | Microbiologics, Inc. | 2018-08-28 |
| DemeTECH DemeDIOX absorbable surgical suture (K181582) | Demetech Corporation | 2018-08-27 |
| DENV Detect NS1 ELISA (K181473) | InBios International, Inc. | 2018-08-27 |
| Tranquil Interbody System (K181483) | Nexus Spine, LLC | 2018-08-27 |
| JO Classic Hybrid Personal Lubricant (K181408) | United Consortium | 2018-08-27 |
| BenQ Diagnostic Ultrasound System (K181313) | Qisda Corporation | 2018-08-27 |
| Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw (K180179) | Orthofix, Inc. | 2018-08-24 |
| APTUS CMC-I Fusion Plate System (K181009) | Medartis AG | 2018-08-24 |
| EPINAUT (K173541) | Imedicom Co., Ltd. | 2018-08-24 |
| NuVasive Brigade Lateral System (K181386) | Nu Vasive, Incorporated | 2018-08-24 |
| AcuSnare Polypectomy Snare (K173673) | Wilson-Cook Medical, Inc. | 2018-08-24 |
| Solitaire 2 and Solitaire Platinum Revascularization Device (K181060) | Medtronic Neurovascular | 2018-08-24 |
| EasyMax BT Self-Monitoring Blood Glucose System (K182057) | Eps Bio Technology Corp. | 2018-08-24 |
| CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module (K173978) | Biosense Webster, Inc. | 2018-08-24 |
| IOLMaster 700 (K173771) | Carl Zeiss Meditec, AG | 2018-08-24 |
| RadiForce GX560, GX560-AR (K181609) | Eizo Corporation | 2018-08-24 |
| AOS Small Fragment Plating System Lite (K181035) | Advanced Orthopaedic Solutions, Inc. (Aos) | 2018-08-24 |
| Double Medical Femoral Nail System (K172830) | Double Medical Technology, Inc. | 2018-08-24 |
| NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter (K180040) | Abbott Vascular | 2018-08-24 |
| CancelleX Porous Titanium Lumbar Interbody Device (K180373) | Xenco Medical, LLC | 2018-08-24 |
| Smylic Invisible Clear Aligners (K173784) | Smylio, Inc. | 2018-08-23 |
| MATRx plus (DEN170090) | Zephyr Sleep Technologies | 2018-08-23 |
| MyoSure XL Tissue Removal Device for Fluent (K181974) | Hologic, Inc. | 2018-08-23 |
| GMK Sphere - Kinematic Alignment (K173890) | Medacta International S.A. | 2018-08-23 |
| ADVIA Centaur Herpes-1 IgG (K181333) | Biokit, S.A. | 2018-08-23 |
| Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter (K173657) | Cook Incorporated | 2018-08-23 |
| ADVIA Centaur Herpes-2 IgG (K181334) | Biokit, S.A. | 2018-08-23 |
| Z-CAD smile (K170050) | Metoxit AG | 2018-08-23 |
| GMK Sphere CR Tibial Inserts (K181635) | Medacta International S.A. | 2018-08-23 |
| Stat Profile Prime Plus Analyzer System (K180186) | Nova Biomedical Corporation | 2018-08-23 |
| Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit (K173732) | The Binding Site Group , Ltd. | 2018-08-23 |
| SpyGlass DS and DS II Direct Visualization System (K181439) | Boston Scientific Corporation | 2018-08-23 |
| Freespira (K180173) | Palo Alto Health Sciences, Inc. | 2018-08-23 |
| NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe (K180542) | Boston Endo Surgical Tech, | 2018-08-22 |
| autoLog IQ Autotransfusion System (K181954) | Medtronic Perfusion Systems | 2018-08-22 |
| GrandioSO x-tra (K181312) | Voco GmbH | 2018-08-22 |
| Non-invasive blood pressure measurement systems (K173024) | Joytech Healthcare Co. , Ltd. | 2018-08-22 |
| H. PYLORI QUIK CHEK (K181379) | Techlab, Inc. | 2018-08-21 |
| exGraft, exGraft Carbon ePTFE Vascular Grafts (K180957) | Peca Labs | 2018-08-21 |
| ATEC Cervical Spacer System (K181435) | Alphatec Spine, Inc. | 2018-08-21 |
| PENTAX Medical Endoscopic Ultrasound System (K182004) | Pentax of America, Inc. | 2018-08-21 |
| MIDAScope and Introducer Kit, and MIDASystem (K181982) | Intravu, Inc. | 2018-08-21 |
| SIMPLYSTRONG, SIMPLYEZEE (K181791) | Genicon, Inc. | 2018-08-21 |
| H. PYLORI CHEK™ (K181400) | Techlab, Inc. | 2018-08-21 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K181973) | Medtronic, Inc. | 2018-08-21 |
| Confidence Blood Glucose Monitoring System (K173658) | Applied Biomedical, LLC | 2018-08-21 |
| PICO 7 Single Use Negative Pressure Wound Therapy System (K180698) | Smith & Nephew Medical Limited | 2018-08-21 |
| Reusable NIBP Cuff (K173197) | Orantech, Inc. | 2018-08-21 |
| Fever Scout (K181013) | VivaLNK, Inc. | 2018-08-21 |
| BD Vacutainer Eclipse Signal Blood Collection Needle (K170824) | Becton, Dickinson and Company | 2018-08-20 |
| BEXCORE Breast Biopsy System, Biopsy Needle (K171890) | Medical Park Co., Ltd. | 2018-08-20 |
| AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (K181768) | Assure Tech. (Hangzhou) Co, Ltd. | 2018-08-20 |
| re.t.a Reuseable Tampon Applicator (K180850) | Thinx, Inc. | 2018-08-20 |
| SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (K181968) | Safecare Biotech (Hangzhou) Co., Ltd. | 2018-08-20 |
| Young INFINITY Cordless Handpiece System (K171377) | Young Dental Manufacturing Co. 1, LLC | 2018-08-20 |
| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) | W. L. Gore & Associates, Inc. | 2018-08-17 |