| DRI OCT Triton (K173119) | Topcon Corporation | 2018-01-19 |
| KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (K171731) | Kronus, Inc. | 2018-01-19 |
| EM-4000 Specular Microscope (K171313) | Tomey Corporation | 2018-01-19 |
| PreXion3D Excelsior (K173878) | Prexion Corporation | 2018-01-19 |
| PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope (K173554) | Pentax of America, Inc. | 2018-01-19 |
| BioSphere MIS Putty (BioSphere MIS) (K173301) | Synergy Biomedical, LLC | 2018-01-19 |
| Focus Cap (K171673) | Gce Medical Corporation | 2018-01-19 |
| Reliance Lumbar IBF System (K173283) | Reliance Medical Systems, LLC | 2018-01-19 |
| ReddyPort NIV Access Elbow (K171827) | Smd Manufacturing, LLC | 2018-01-19 |
| DIP Arthrodesis System (K173616) | In2bones Sas | 2018-01-19 |
| OnSight 3D Extremity System (K173478) | Carestream Health, Inc. | 2018-01-19 |
| Angel Align System (K171674) | Smile Development Corp | 2018-01-19 |
| FORZA® XP Expandable Spacer System (K172696) | Orthofix, Inc. | 2018-01-19 |
| Fiji Anchor (K171228) | Sportwelding GmbH | 2018-01-19 |
| Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume (K173891) | Vascular Solutions, Inc. | 2018-01-19 |
| Straumann Dental Implant System (K171784) | Straumann USA, LLC | 2018-01-19 |
| LINK® BiMobile(TM) Dual Mobility System (K171273) | Waldemar Link GmbH & Co. KG | 2018-01-19 |
| FUJIFILM Bronchoscope Model EB-530P (K171291) | Fujifilm Medical Systems U.S.A, Inc. | 2018-01-19 |
| GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert (K173875) | Stelkast, Inc. | 2018-01-19 |
| Choice Spine Laminoplasty™ Fixation System (K173215) | Choicespine, LP | 2018-01-19 |
| Nurture Rest (K172962) | Neonatal Loving Kare, Inc. | 2018-01-18 |
| Stryker AIM Light Source and SafeLight cable (K173866) | Stryker | 2018-01-18 |
| BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap (K172575) | Baronova, Inc. | 2018-01-18 |
| Flex Robotic System and Flex Transabdominal Drive (K172796) | Medrobotics Corporation | 2018-01-18 |
| Pelvifine Pelvic Muscle Trainer (K163288) | Shenzhen Konmed Technology Co., Ltd. | 2018-01-18 |
| Navigated INFINITY™ Instruments (K173338) | Medtronic Sofamor Danek USA, Inc. | 2018-01-18 |
| FMS VUE II Fluid Management and Tissue Debridement System (K171237) | Medos International SARL | 2018-01-18 |
| PulsioFlex Monitoring System (K172259) | Pulsion Medical Systems SE | 2018-01-18 |
| Tritanium® TL Curved Posterior Lumbar Cage (K173476) | Stryker | 2018-01-18 |
| Barrx SB RFA Endoscopic Catheter (K173559) | Covidien, LLC | 2018-01-18 |
| AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System (K172319) | STERIS Corporation | 2018-01-18 |
| Lumilisse IPL Hair Remover (K172791) | Conair Corporation | 2018-01-18 |
| NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) (K173479) | Novo Nordisk, Inc. | 2018-01-17 |
| Endotracheal tube; Reinforced Endotracheal tube (K170234) | Zhanjiang Star Enterprise Co., Ltd. | 2018-01-17 |
| epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test (K171247) | Epocal, Inc. | 2018-01-17 |
| Kinsa QuickCare Thermometer (K173730) | Kinsa, Inc. | 2018-01-17 |
| Unity Total Knee System (K173884) | Corin U.S.A. Limited | 2018-01-17 |
| ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes (K173582) | Thermigen, L.L.C | 2018-01-17 |
| PROPEL Device (K172164) | Propel Orthodontics, LLC | 2018-01-17 |
| OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) (K173820) | Boston Scientific Corporation | 2018-01-17 |
| OBA-MCP, Orthodontic Bracket Adhesive with MCP (K173020) | Pulpdent Corporation | 2018-01-17 |
| Ortho System (K171634) | 3Shape A/S | 2018-01-17 |
| ARIA Radiation Therapy Management (K173838) | Varian Medical Systems, Inc. | 2018-01-17 |
| Medline Disposable Electronic Thermometer Probe Cover (K173113) | Medline Industries, Inc. | 2018-01-17 |
| Arthrex PushLock (K173240) | Arthrex, Inc. | 2018-01-16 |
| Navigo Workstation Version 2.0 (K173054) | UC-CARE , Ltd. | 2018-01-16 |
| Quickie(r) Q700-UP M (K172384) | Sunrise Medical (Us), LLC | 2018-01-16 |
| Activ Ankle (K173641) | Newclip Technics | 2018-01-16 |
| Yamahachi Pink CAD/CAM Disk (K172683) | YAMAHACHI DENTAL MFG., Co. | 2018-01-16 |
| K2M Navigation Instruments (K171556) | K2m | 2018-01-16 |
| ACCLARENT AERA Eustachian Tube Balloon Dilation System (K171761) | Acclarent, Inc. | 2018-01-16 |
| Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt (K172189) | Truemed Group, LLC | 2018-01-16 |
| CS Imaging (K173622) | Trophy | 2018-01-16 |
| Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel (K172977) | Nanova Biomaterials, Inc. | 2018-01-16 |
| Elos Accurate Customized Abutment, Elos Prosthetic Screw (K171799) | Elos Medtech Pinol A/S | 2018-01-15 |
| MR4 Laser (K171354) | Multi Radiance Medical | 2018-01-13 |
| Aleo BME Liquid Bandage (K171148) | Aleo Bme, Inc. | 2018-01-12 |
| Action Trackstander models TR1816, TR1820, TR2016, and TR2020 (K163451) | Action Manufacturing, Inc. | 2018-01-12 |
| ImagenUniversal (K173547) | Cardiovascular Imaging Technologies | 2018-01-12 |
| HI-TORQUE TurnTrac Guide Wire Family (K173795) | Abbott Vascular | 2018-01-12 |
| A5 Anesthesia System (K171311) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-12 |
| ipsogen JAK2 RGQ PCR Kit (K172287) | Qiagen, Inc. | 2018-01-12 |
| ARBOR External Fixation System (K172438) | Globus Medical, Inc. | 2018-01-12 |
| syngo.via RT Image Suite (K173635) | Siemens Medical Solutions USA, Inc. | 2018-01-12 |
| One Touch Condom with Benzocaine (K171213) | Thai Nippon Rubber Industry Public Company Limited. | 2018-01-12 |
| Single Lumen Ovum Aspiration Needles (K171625) | Willian A. Cook Australia Pty, Ltd. | 2018-01-12 |
| A7 Anesthesia System (K171292) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-12 |
| PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (K171958) | Mectron S.P.A. | 2018-01-12 |
| T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (K172774) | Stryker Trauma GmbH | 2018-01-12 |
| Optima XR240amx, AutoGrid (K173602) | Ge Medical Systems, LLC | 2018-01-12 |
| GU60A & GU60A-65 (K173828) | Samsung Electronics Co., Ltd. | 2018-01-12 |
| Illumeo System (K173588) | Philips Medical Systems Technologies , Ltd. | 2018-01-12 |
| IRRIS (Infra-Red-Red Intubation System) (K171411) | A.R Guide IN Medical , Ltd. | 2018-01-12 |
| Microcatheter (K173560) | Surmodics,Inc. | 2018-01-12 |
| MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (K171498) | Meso Scale Diagnostics, LLC | 2018-01-12 |
| HBS2 Headless Bone Screw (K171628) | Stuckenbrock Medizintechnik GmbH | 2018-01-12 |
| cobas Factor II and Factor V Test (K172913) | Roche Molecular Systems, Inc. | 2018-01-12 |
| Wiltrom Spinal Fixation System (K172548) | Wiltrom Corporation Limited | 2018-01-12 |
| 6440 Ultrasound System (K173291) | Esaote, S.p.A. | 2018-01-12 |
| K-Y Silicone (K173504) | Reckitt Benckiser, LLC | 2018-01-12 |
| HYDRASHIFT 2/4 daratumumab, daratumumab Control (K172195) | Sebia | 2018-01-11 |
| Automated ankle brachial pressure index measuring device (K172655) | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2018-01-11 |
| Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 (K173090) | Toshibamedical Systems Corporation | 2018-01-11 |
| GLOBAL UNITE Platform Shoulder System (K170748) | Depuy Ireland UC | 2018-01-11 |
| Microcatheter and guide-wire system (K171665) | Suzhou Hengrui Disheng Medical Co., Ltd. | 2018-01-11 |
| Bruxor (K172452) | Sleep Specialties, LLC | 2018-01-11 |
| ExoToe Staple (K172205) | Exotoe, LLC | 2018-01-11 |
| DTX Studio diagnose (K172224) | Nobel Biocare AB | 2018-01-11 |
| Besmed Peak Flow Meter (K172804) | Besmed Health Business Corp | 2018-01-11 |
| Dentium Ti-Base (K171622) | Dentium Co., Ltd. | 2018-01-11 |
| ECHELON OVAL V6.0A MRI System (K172110) | Hitachi Healthcare Americas Corporation | 2018-01-11 |
| Digital Electrocardiograph (K171517) | Biocare Bio-Medical Equipment Co., Ltd. | 2018-01-11 |
| CEREC Ortho Software (K171122) | Dentsply Sirona | 2018-01-11 |
| Diazyme EZ Vitamin D Assay (K172992) | Diazyme Laboratories | 2018-01-11 |
| ET Hybrid Abutment (K170421) | Hiossen, Inc. | 2018-01-11 |
| FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M (K171207) | Fujifilm Medical Systems U.S.A, Inc. | 2018-01-11 |
| Instalief (K172358) | Privi Medical Pte, Ltd. | 2018-01-10 |
| Amplatz Support Wire Guide with Apex Curve (K171445) | Cook Incorporated | 2018-01-10 |
| Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter (K172051) | Cook Incorporated | 2018-01-10 |
| Smith & Nephew Patient Matched Cutting Blocks (K172336) | Smith & Nephew, Inc. | 2018-01-10 |