| Clarius Ultrasound Scanner (K180799) | Clarius Mobile Health Corp. | 2018-05-14 |
| Ventripoint Medical System Plus (VMS+) (K173810) | Ventripoint Diagnostics , Ltd. | 2018-05-14 |
| Disposable Biopsy Valve (K173758) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018-05-14 |
| SeaSpine Daytona Small Stature Spinal System (K180686) | SeaSpine Orthopedics Corporation | 2018-05-14 |
| RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder (K173279) | Myco Medical Supplies, Inc. | 2018-05-14 |
| Dentium Implantium & SuperLine Prosthetics (K172640) | Dentium Co., Ltd. | 2018-05-14 |
| Pristina Serena (K173576) | GE Healthcare | 2018-05-14 |
| ALGS6 Ag Alginate Wound Dressing (K172570) | Foshan United Medical Technologies, Ltd. | 2018-05-11 |
| HS40 Diagnostic Ultrasound System (K180409) | Samsung Medison Co., Ltd. | 2018-05-11 |
| HealthBeacon HB2 Sharps Bin (K172719) | Healthbeacon, Ltd. | 2018-05-11 |
| Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer (K170663) | Foremount Enterprise Co., Ltd. | 2018-05-11 |
| LineUp (K180727) | Curvebeam, LLC | 2018-05-11 |
| Infrared Body Thermometer (K180385) | Hetaida Technology Co., Ltd. | 2018-05-11 |
| Light based hair removal device (K180383) | Shenzhen Gsd Tech Co., Ltd. | 2018-05-11 |
| EmbryoScope+ (K173264) | Vitrolife A/S | 2018-05-11 |
| Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor (K172625) | Nonin Medical, Inc. | 2018-05-11 |
| SeaSpine Navigation System (K172517) | SeaSpine Orthopedics Corporation | 2018-05-11 |
| µCor Heart Failure and Arrhythmia Management System (K172510) | Zoll Manufacturing Corporation | 2018-05-11 |
| Collagentex Rx-6 (K180585) | Tanses Technologies, Inc. | 2018-05-11 |
| Cytal Wound Particulate (K180776) | Acell, Inc. | 2018-05-11 |
| GSI Corti (K180287) | Grason-Stadler, Inc. | 2018-05-11 |
| Spectrum IQ Infusion System, Dose IQ Safety Software (K173084) | Baxter Healthcare Corporation | 2018-05-11 |
| FORE-SIGHT ELITE Module Tissue Oximeter (K180003) | Cas Medical Systems, Inc. | 2018-05-10 |
| OsteoMed QuickFix Hybrid MMF Sterilization Tray (K173391) | Osteomed, LLC | 2018-05-10 |
| Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange (K172867) | Gmp Medicare Sdn Bhd (F25) | 2018-05-10 |
| Pro-Link® Ti Stand-Alone Cervical Spacer System (K180642) | Life Spine, Inc. | 2018-05-10 |
| RadiForce MX194 (K180961) | Eizo Corporation | 2018-05-10 |
| OKTAGON Implant System (K180360) | Hager& Meisinger GmbH | 2018-05-10 |
| OrthoPediatrics PediNail Intramedullary Platform (K172583) | Orthopediatrics, Inc. | 2018-05-10 |
| 2008T BlueStar Hemodialysis Machine (K173972) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-10 |
| ANGIO-PRESS LITE DVT Compression Device (K173012) | Pegasus Medical Supply, Inc. | 2018-05-10 |
| UINCARE HOME (K172882) | Uincare Corp. | 2018-05-10 |
| HEALIX ADVANCE KNOTLESS BR Anchor (K180101) | Medos International SARL | 2018-05-10 |
| Rondek PGA Suture (Beige or Violet) (K180625) | Rk Manufacturing Corporation | 2018-05-10 |
| Graftgun Universal Graft Delivery System (K180937) | SurGenTec, LLC | 2018-05-10 |
| Silk'n MODEL H5003 device (K180279) | Home Skinovations , Ltd. | 2018-05-09 |
| VSI Micro-Introducer Kit (K180913) | Vascular Solutions, Inc. | 2018-05-09 |
| EmboTrap ll Revascularization Device (K173452) | Neuravi, Ltd. | 2018-05-09 |
| Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad (K172145) | Medela AG | 2018-05-09 |
| STERIZONE VP4 Sterilizer (K172191) | Tso3, Inc. | 2018-05-09 |
| Faxitron VisionCT (K173309) | Faxitron Bioptics, LLC | 2018-05-09 |
| CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set (K173202) | Sekisui Medical Co., Ltd. | 2018-05-09 |
| DSM Biomedical Calcium Phosphate Cement with Microspheres (K173572) | Kensey Nash Corporation Dba Dsm Biomedical | 2018-05-09 |
| Halcyon (K181032) | Varian Medical Systems, Inc. | 2018-05-09 |
| Diamond Orthopedic Bone Fixation Screws and Pins (K180932) | Diamond Orthopedic, LLC | 2018-05-09 |
| Klassic HD® Hip System (K180929) | Total Joint Orthopedics, Inc. | 2018-05-09 |
| ARTHRO-Pump PA304 (K173311) | W.O.M. World of Medicine GmbH | 2018-05-09 |
| Navi e/Navi s/Navi X Diagnostic Ultrasound System (K180461) | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2018-05-09 |
| MyoSure MANUAL Tissue Removal Device (K173901) | Hologic, Inc. | 2018-05-08 |
| BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube (K173912) | Smiths Medical Asd, Inc. | 2018-05-08 |
| Meron Plus QM (K180386) | Voco GmbH | 2018-05-08 |
| Glidesheath Slender (K173831) | Terumo Medical Corporation | 2018-05-08 |
| VENTANA CD30 (Ber-H2) RxDx Assay (K172471) | Ventana Medical Systems, Inc. | 2018-05-08 |
| Empower H100, Cyber Ho 100, Litho 100 (K180922) | Quanta System Spa | 2018-05-08 |
| STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX (K173347) | Centinel Spine, Inc. | 2018-05-08 |
| Trident Extremity Fixation System (K171690) | Trident Orthopedics | 2018-05-08 |
| Fetzer Medical Gynecological Forceps (K172661) | Fetzer Medical GmbH & Co. KG | 2018-05-08 |
| A-CIFT SoloFuse (K172484) | Spinefrontier, Inc. | 2018-05-08 |
| SB Soft Hood - Straight type, SB Soft Hood - Undercut type (K173004) | Sumitomo Bakelite Co., Ltd. | 2018-05-08 |
| BioStamp nPoint (K173510) | Mc10, Inc. | 2018-05-08 |
| Afinion HbA1c Dx (K180296) | Alere Technologies AS | 2018-05-07 |
| Weinmann Tracheostomy Exchange Set (K180034) | Cook Incorporated | 2018-05-07 |
| Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation (K180079) | Hill-Rom, Inc. | 2018-05-07 |
| Hemospray Endoscopic Hemostat (DEN170015) | Wilson-Cook Medical, Inc. | 2018-05-07 |
| Endopath Electrosurgery Probe Plus II (K180031) | Ethicon Endo-Surgery, LLC | 2018-05-07 |
| g.Estim PRO (K173684) | G.Tec Medical Engineering GmbH | 2018-05-04 |
| NuVasive® XLX Interbody System (K173892) | Nu Vasive, Incorporated | 2018-05-04 |
| QT ECG (K180157) | QT Medical, Inc. | 2018-05-04 |
| VitriGuard (K180740) | Origio A/S | 2018-05-04 |
| Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left (K172614) | Caldera Medical, Inc. | 2018-05-04 |
| EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System (K180317) | Microport Orthopedics, Inc. | 2018-05-04 |
| Apollo TMS Therapy System (K180313) | Mag & More GmbH | 2018-05-04 |
| URIS OMNI System (K172100) | Truabutment, Inc. | 2018-05-04 |
| Trackit T4 EEG Amplifier (K172271) | Lifelines , Ltd. | 2018-05-04 |
| Wallaby Avenir Coil System (K173711) | Wallaby Medical, Inc. | 2018-05-04 |
| TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System (K173345) | Taidoc Technology Corporation | 2018-05-04 |
| MEDRAD® Imaging Bulk Package Transfer Set (K173913) | Bayer U.S., LLC | 2018-05-04 |
| 3.0 Dynamic TiBase (K162021) | Talladium Espana, SL | 2018-05-04 |
| Ulthera System (K180623) | Ulthera, Inc. | 2018-05-04 |
| Invenia ABUS Viewer (K180641) | GE Healthcare | 2018-05-04 |
| Hexanium® TLIF (K180437) | Spinevision, S.A.S. | 2018-05-04 |
| Cervage (K172568) | Precifit Medical, Ltd. | 2018-05-04 |
| StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO (K173874) | Origami Surgical, LLC | 2018-05-04 |
| EVOL Spinal Interbody System, EVOS Lumbar Interbody System (K180891) | Cutting Edge Spine, LLC | 2018-05-04 |
| VivaScope System (K180162) | Caliber Imaging & Diagnostics, Inc. | 2018-05-03 |
| PIEZOTOME CUBE (K172137) | Satelec - Acteon Group | 2018-05-03 |
| Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 (K172777) | PAJUNK GmbH Medizintechnologie | 2018-05-03 |
| STYLO Interbody Fusion Device (K180071) | Legend Spine Technologies | 2018-05-03 |
| CAAS Workstation (K180019) | Pie Medical Imaging BV | 2018-05-03 |
| Fluorescence Mode (K171007) | Carl Zeiss Suzhou Co., Ltd. | 2018-05-03 |
| Repris Bladder Injection System (K180214) | Uro-1, Inc. | 2018-05-03 |
| Medtronic Confida Brecker Guidewire (K181001) | Medtronic Core Valve, LLC | 2018-05-03 |
| Indigo Aspiration System - Modified 110 Aspiration Tubing (K180939) | Penumbra, Inc. | 2018-05-03 |
| Smartcord, Smartcord X (K171577) | Eastdent Co., Ltd. | 2018-05-03 |
| Brainsway Deep (DTMS) System (K173540) | Brainsway , Ltd. | 2018-05-03 |
| Micropuncture Pedal Access Set (K172980) | Cook Incorporated | 2018-05-03 |
| Venue (K180599) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-05-02 |
| Accu O2 Oxygen Analyzer (K173807) | Precision Medical, Inc. | 2018-05-02 |
| MC 300R* Nebulizer (K173825) | Trudell Medical International | 2018-05-02 |
| Cook 810 Set, Desilets-Hoffman Introducer Set (K180028) | Cook Incorporated | 2018-05-02 |