| K181442 — VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation Jun 13, 2018 |
| K181298 — Harmony XL Multi-Application Platform | Alma Lasers, Inc. Jun 13, 2018 |
| K180989 — PEDRA-17F Digital Flat Panel X-ray Detector | Radisen, Inc. Jun 13, 2018 |
| K181279 — Ysio Max | Siemens Medi Cal Solutions, Inc. Jun 13, 2018 |
| K180861 — Vinyl Examination Glove (Clear, Non-Colored) | Zhicheng Trading Co., Ltd. Jun 13, 2018 |
| K180681 — Aptima Combo 2 Assay (Panther System) | Hologic, Inc. Jun 13, 2018 |
| K181050 — Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) | Qualimed Srl Jun 13, 2018 |
| K173259 — Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories | Case Medical, Inc. Jun 13, 2018 |
| K181363 — EcoVue Sterile and Non-Sterile Ultrasound Gels | H R Pharmaceuticals, Inc. Jun 13, 2018 |
| K181271 — Signature Orthodontic System | Signature Orthodontics Jun 13, 2018 |
| K172983 — HealthCCS | Zebra Medical Vision, Ltd. Jun 13, 2018 |
| K180818 — Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) | Tenon Medical, Inc. Jun 13, 2018 |
| DEN170043 — DreaMed Advisor Pro | DreaMed Diabetes, Ltd. Jun 12, 2018 |
| K180124 — ZQuiet | Sleeping Well, LLC Jun 12, 2018 |
| K180452 — White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim | Riverstone Resources Sdn Bhd Jun 12, 2018 |
| K181343 — HeartSee Cardiac P.E.T. Processing Software | Bracco Diagnostics, Inc. Jun 12, 2018 |
| K180260 — Powder Free Vinyl Patient Examination Gloves (Yellow, White) | Shanxi Hongjin Plastic Technology Co., Ltd. Jun 12, 2018 |
| K172823 — Portex NRFit Epidural Needles | Smiths Medical Asd, Inc. Jun 12, 2018 |
| K172833 — E-XPE Acetabular Components and U-Motion II Acetabular Cup | United Orthopedic Corporation Jun 12, 2018 |
| K181093 — SyMRI | Syntheticmr AB Jun 12, 2018 |
| K172831 — Perfusor® Space Syringe Infusion Pump System | B.Braun Medical, Inc. Jun 12, 2018 |
| K172783 — Access hs Tnl | Beckman Coulter, Inc. Jun 12, 2018 |
| K180849 — Vinyl Examination Glove (Clear, Non-Colored) | Huifu Trading Co., Ltd. Jun 11, 2018 |
| K173503 — Pollogen Legend System | Pollogen, Ltd. Jun 11, 2018 |
| K173200 — SOFIA Plus Aspiration Catheter | MicroVention, Inc. Jun 11, 2018 |
| K173803 — Omnican fine | B.Braun Medical, Inc. Jun 11, 2018 |
| K181281 — Altus Spine Pedicle Screw System | Altus Partners, LLC Jun 11, 2018 |
| K172835 — GRI-Alleset Veress Needle | Gri Medical And Electronic Technology Co., Ltd. Jun 11, 2018 |
| K172961 — LIAC HWL | Sit Sordina Iort Technologies Spa Jun 11, 2018 |
| K173787 — X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System | Medos International SARL Jun 11, 2018 |
| K180959 — Phenom 27 Catheter | Cathera, Inc. Jun 11, 2018 |
| K180722 — CAPERE Thrombectomy System | Kp Medcure, Inc. Jun 11, 2018 |
| K180766 — Endiscope, Endiscope Cervical | Elliquence, LLC Jun 11, 2018 |
| K171422 — Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color | Ever Global (Vietnam) Enterprise Corp Jun 11, 2018 |
| K172821 — Ti-one 101 TS Dental Implant System | Hung Chun Bio-S Co., Ltd. Jun 11, 2018 |
| K180649 — BeautiCem Veneer Kit | Shofu Dental Corporation Jun 11, 2018 |
| K180449 — Single Use Aspiration Needle NA-U200H | Olympus Medical Systems Corp. Jun 8, 2018 |
| K180660 — Avanti | Optovue, Inc. Jun 8, 2018 |
| K173156 — Integrated CardioRespiratory System | Sensydia, Inc. Jun 8, 2018 |
| K173189 — Lumfuse TP | Precifit Medical, Ltd. Jun 8, 2018 |
| K173706 — Piccolo Implants and Accessories | Southern Implants (Pty), Ltd. Jun 8, 2018 |
| K180985 — Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses | Supervision Optimax Sdn Bhd Jun 8, 2018 |
| K180332 — 17HK700G-W | Lg Electronics Jun 8, 2018 |
| K172725 — VT Dressing Kits | Carilex Medical, Inc. Jun 8, 2018 |
| K180988 — Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. Jun 8, 2018 |
| K180904 — Sniper Infusion Catheter with Balloon Occlusion | Embolx, Inc. Jun 8, 2018 |
| K172981 — Reusable SpO2 Sensors, Disposable SpO2 Sensors | APK Technology Co., Ltd. Jun 8, 2018 |
| K180306 — Nexy | Next Sight Srl Jun 8, 2018 |
| K173070 — HSW Resection Instruments | Henke-Sass, Wolf GmbH Jun 8, 2018 |
| K180947 — Orthopantomograph OP 3D | Palodex Group OY Jun 7, 2018 |