| 17HK701G-W (K183286) | Lg Electronics.Inc | 2018-12-07 |
| Nihon Kohden NKV-550 Series Ventilator System (K181695) | Nihon Kohden Orangemed, Inc. | 2018-12-07 |
| GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A (K182183) | Samsung Electronics Co., Ltd. | 2018-12-07 |
| BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody (K183102) | Leica Biosystems Newcastle, Limited | 2018-12-07 |
| Contour 24 (K183111) | Quality Electrodynamics, LLC | 2018-12-07 |
| CUSA Clarity Ultrasonic Surgical Aspirator System (K182809) | Integra LifeSciences Corporation | 2018-12-07 |
| Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra (K183100) | Leica Biosystems Newcastle, Limited | 2018-12-07 |
| FiXcision (K182664) | Agency For Medical Innovations GmbH | 2018-12-07 |
| Nexus DR Digital X-ray Imaging System with stitching (K183212) | Varex Imaging Corporation | 2018-12-07 |
| Neck Care Therapy, Model: SYK 509B (K172897) | Shenzhen Osto Technology Co., Ltd. | 2018-12-07 |
| Resin for Temporary Crown & Bridge (K180657) | Dentis Co., Ltd. | 2018-12-07 |
| C-Zero Pedicle Screw System, Freedom Pedicle Screw System (K180754) | Signature Orthopaedics Pty, Ltd. | 2018-12-07 |
| Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 (K181583) | Flexicare Medical Limited. | 2018-12-07 |
| Avenir Complete Hip System (K182048) | Zimmer, Inc. | 2018-12-07 |
| Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System (K182007) | Renovis Surgical Technologies | 2018-12-07 |
| SignalMark Lung Biopsy Site Marker (K180175) | View Point Medical, Inc. | 2018-12-07 |
| PATRIOT® Lumbar Spacers, SUSTAIN® Spacers (K181357) | Globus Medical, Inc. | 2018-12-06 |
| PowerLook Tomo Detection V2 Software (K182373) | Icad, Inc. | 2018-12-06 |
| Unity Network ID (K183116) | GE Healthcare | 2018-12-06 |
| KerraContact Ag Perf Advanced Perforated Silver Wound Dressing (K182680) | Exciton Technologies, Inc. | 2018-12-06 |
| FFRct (K182035) | HeartFlow, Inc. | 2018-12-06 |
| EVOLUTION Stemmed CS Femur (K182125) | Microport Orthopedics, Inc. | 2018-12-06 |
| AMRA Profiler (K173749) | Amra Medical AB | 2018-12-06 |
| Simplicit90Y (K182016) | Mirada Medical, Ltd. | 2018-12-06 |
| DePuy Synthes T-PAL Spacer System (K181231) | Depuy Synthes Spine | 2018-12-06 |
| Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths (K182006) | Hologic, Inc. | 2018-12-06 |
| IntelliSpace Radiology (K182926) | Philips Healthcare Informatics, Inc. | 2018-12-06 |
| Zenition 70 (K183040) | Philips Medical Systems Nederland B.V. | 2018-12-06 |
| RII Smart IR Thermometer (K163601) | Radiant Innovation, Inc. | 2018-12-06 |
| Senhance Surgical System (K183098) | Transenterix, Inc. | 2018-12-06 |
| Elevo® Kit Snoring Intervention Device (K181107) | Zelegent, Inc. | 2018-12-06 |
| Vivid iq (K181727) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-12-06 |
| Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection (K181529) | Contego Medical, LLC | 2018-12-06 |
| MagnetOs Putty (K181958) | Kuros Biosciences B.V | 2018-12-06 |
| Synthetic Polyisoprene Lubricated Male Condom - 5 senses (K182438) | Sxwell USA, LLC | 2018-12-06 |
| No-contact Forehead Thermometer (K173048) | Dongguan Simzo Electronic Technology Co., Ltd. | 2018-12-06 |
| Endoform Reconstructive Template - Non Absorbable (K181935) | Aroa Biosurgery , Ltd. | 2018-12-04 |
| MOSAIQ Oncology Information System (K183034) | Elekta, Inc. | 2018-12-04 |
| Coolrail Linear Pen (K183065) | AtriCure, Inc. | 2018-12-04 |
| 6420 Ultrasound System (K183191) | Esaote, S.p.A. | 2018-12-04 |
| Healix™ Compression Screw System (K182949) | Nvision Biomedical Technologies, LLC | 2018-12-04 |
| NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus (K182479) | Hycor Biomedical | 2018-12-04 |
| Spartan eCoil System (K180653) | Spartan Micro, Inc. | 2018-12-04 |
| Monaco RTP System (K183037) | Elekta, Inc. | 2018-12-04 |
| AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter (K180615) | Fresenius Kabi USA,Llc | 2018-12-04 |
| Elekta Unity (K182076) | Elekta Limited | 2018-12-04 |
| CAAS MR Solutions (K181825) | Pie Medical Imaging BV | 2018-12-04 |
| HS50 / HS60 Diagnostic Ultrasound System (K181336) | Samsung Medison Co., Ltd. | 2018-12-04 |
| NobelZygoma 0° (K183069) | Nobel Biocare AB | 2018-12-04 |
| MectaLIF Posterior Extension (K181970) | Medacta International S.A. | 2018-12-04 |
| Action Trackchair (K181908) | Action Manufacturing, Inc. | 2018-12-03 |
| Wondfo T-Cup Multi-Drug Urine Test Cup (K182701) | Guangzhou Wondfo Biotech Co., Ltd. | 2018-12-03 |
| LZI Fentanyl Enzyme Immunoassay (K181159) | Lin-Zhi International, Inc. | 2018-12-03 |
| IMPLANTER DENTAL PLANNING SOFTWARE (K173083) | Implanter, LLC | 2018-12-03 |
| Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set (K182146) | Sol-Millennium Medical, Inc. | 2018-12-03 |
| xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) (K183023) | Luminex Molecular Diagnostics, Inc. | 2018-11-30 |
| Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K182600) | Better Care Plastic Technology Co., Ltd. | 2018-11-30 |
| Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System (K182046) | Tyson Bioresearch, Inc. | 2018-11-30 |
| Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System (K182663) | Finemec Co., Ltd. | 2018-11-30 |
| POPS! one Blood Glucose Monitoring System (K181588) | Taidoc Technology Corporation | 2018-11-30 |
| Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit (DEN180040) | Meridian Bioscience, Inc. | 2018-11-30 |
| Advanced Skin Renewing Device (K182498) | Jiangsu Unimed Laser Technology Co., Ltd. | 2018-11-30 |
| Tinnitus Sound Generator Module (K180495) | GN Hearing A/S | 2018-11-30 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL (K182797) | Thermo Fisher Scientific | 2018-11-30 |
| Ambu aScope RLS Slim (K181286) | Ambu A/S | 2018-11-30 |
| xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) (K183030) | Luminex Molecular Diagnostics, Inc. | 2018-11-30 |
| ZOLL Propaq M (K180482) | ZOLL Medical Corporation | 2018-11-30 |
| ChitoZolve (K181696) | Gyrus Acmi, Inc. | 2018-11-30 |
| SubtlePET (K182336) | Subtle Medical, Inc. | 2018-11-30 |
| BD PhaSeal Optima Closed System Transfer Device (K181221) | Becton, Dickinson and Company | 2018-11-30 |
| Planmed Verity (K180918) | Planmed OY | 2018-11-30 |
| Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens (K182249) | Bausch & Lomb, Incorporated | 2018-11-30 |
| EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System (K182245) | Edwards Lifesciences, LLC | 2018-11-30 |
| Arterial Pressure Monitoring Set/Tray (K180792) | Cook Incorporated | 2018-11-30 |
| FerriSmart Analysis System (K182218) | Resonance Health Analysis Services Pty, Ltd. | 2018-11-30 |
| Spectra S3 Plus (K181784) | Uzinmedicare Co. | 2018-11-30 |
| welloStationX (K180298) | Wello, Inc. | 2018-11-30 |
| Transcend 365 miniCPAP System (K180388) | Somnetics International, Inc. | 2018-11-30 |
| Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART (K181524) | Vyaire Medical, Inc. | 2018-11-30 |
| UNO Negative Pressure Wound Therapy System (K180840) | Genadyne Biotechnologies, Inc. | 2018-11-30 |
| XVWeb 3D (K182815) | Apteryx, Inc. | 2018-11-30 |
| ASI Automated ASI RPR Test for Syphilis on the ASI Evolution (K182391) | Arlington Scientific, Inc. (Asi) | 2018-11-30 |
| Prizma (K173589) | G-Medical Innovations , Ltd. | 2018-11-30 |
| Single Use Hot Biopsy Forceps FD-231 (K173495) | Olympus Medical Systems Corp. | 2018-11-30 |
| Espire Elbow Pro, Espire Elbow Hybrid (K182757) | College Park Industries, Inc. | 2018-11-29 |
| AS-3XX Series Fingertip Pulse Oximeter (K180685) | Xiamen Acurio Instruments Co., Ltd. | 2018-11-29 |
| Ceramic Denture Zirconia Ceramics Block (K181816) | Qinhuangdao Silide Ceramic Technology Co., Ltd. | 2018-11-29 |
| V3 Segmental Plating System (K182418) | Atlas Spine, Inc. | 2018-11-29 |
| Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System (K182047) | Tyson Bioresearch, Inc. | 2018-11-29 |
| Thoraguard System (K181667) | Centese, Inc. | 2018-11-29 |
| Afinion HbA1c Dx on Afinion 2 (K182988) | Alere Technologies AS | 2018-11-29 |
| BD MAX Enteric Viral Panel, BD MAX Instrument (K181427) | Becton, Dickinson and Company | 2018-11-29 |
| Persyst 14 EEG Review and Analysis Software (K182181) | Persyst Development Corporation | 2018-11-29 |
| Device Electrosurgical Generator ESG-150 (K182587) | Olympus Winter & Ibe GmbH | 2018-11-29 |
| VivaSight-SL (TVT) system (K181880) | Etview , Ltd. | 2018-11-29 |
| Implant-One System (K173701) | Implant Logistics, Inc. | 2018-11-29 |
| SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System (K180665) | K2m, LLC | 2018-11-28 |
| NuVasive Reline Fenestrated Screws, High V+ Bone Cement (K180498) | Nu Vasive, Incorporated | 2018-11-28 |
| Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks (K183010) | Smith & Nephew, Inc. | 2018-11-28 |
| SMS Femoral Stem (K181693) | Medacta International S.A. | 2018-11-28 |