| K180099 — Optilite High Sensitivity C-Reactive Protein Kit | The Binding Site Group , Ltd. Oct 12, 2018 |
| K181644 — EIT Cellular Titanium® Lumbar Cage LLIF | Eit Emerging Implant Technologies GmbH Oct 12, 2018 |
| K181220 — Juell 3D Volo Base | Park Dental Research Corporation Oct 12, 2018 |
| K181651 — Radial Medical Compression System | Radial Medical, Inc. Oct 12, 2018 |
| K180446 — b-ONE Total Knee System | B-One Ortho, Corp. Oct 12, 2018 |
| K182237 — uMI 550 PET/CT System | Shanghai United Imaging Healthcare Co., Ltd. Oct 12, 2018 |
| K182129 — MAGNETOM Sola | Siemens Medical Solutions USA, Inc. Oct 12, 2018 |
| K181539 — OSSDSIGN Cranioplug | Ossdsign AB Oct 12, 2018 |
| K181852 — Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. Oct 12, 2018 |
| K182504 — 3.0T Air MP M, 3.0T Air MP L | Ge Healthcare Coils (Usa Instruments, Inc.) Oct 12, 2018 |
| K180620 — Endophys Pressure Sensing Sheath Kit | Endophys Holdings, LLC Oct 12, 2018 |
| K181848 — ADAPT for Gamma3, Gamma3 | Stryker GmbH Oct 12, 2018 |
| K181569 — BKS Revision Sleeves System | Ortho Development Corporation Oct 12, 2018 |
| K181640 — X-BOLT Hip Fracture Fixation System | X-Bolt Orthopaedics Oct 12, 2018 |
| K180991 — AG 100s | Hospitech Respiration , Ltd. Oct 12, 2018 |
| K182247 — ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) | Vizionfocus, Inc. Oct 12, 2018 |
| K182151 — MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate | Ctl Medical Corporation Oct 11, 2018 |
| K182244 — Voyant Electrosurgical Generator | Applied Medical Resources Corp. Oct 11, 2018 |
| K180249 — OmniPore DUROMAX Surgical Implants | Matrix Surgical Holdings, LLC/Matrix Surgical USA Oct 11, 2018 |
| K181460 — OnePacs System | Onepacs, LLC Oct 11, 2018 |
| K181520 — Sirona Dental CAD/CAM System | Dentsply Sirona Oct 11, 2018 |
| K181091 — AxSOS 3 Ti | Stryker GmbH Oct 11, 2018 |
| K181426 — Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) | Jiangsu Micsafe Medical Technology Co., Ltd. Oct 11, 2018 |
| K180555 — Ergoline Prestige 1600 Hybrid Performance | Jk Holding GmbH Oct 11, 2018 |
| K181503 — Fingertip Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. Oct 11, 2018 |
| K182826 — Ormco Spark Aligner System | Sybron Dental Specialties Oct 11, 2018 |
| K180872 — SCARLET SRF | VIOL Co., Ltd. Oct 11, 2018 |
| K182015 — Piccolo Composite® Plate System | CarboFix Orthopedics , Ltd. Oct 11, 2018 |
| K181617 — E-CUBE 8 | Alpinion Medical Systems Co., Ltd. Oct 11, 2018 |
| K181008 — NuFACE Trinity | Carol Cole Company Dba Nuface Oct 11, 2018 |
| K181330 — NeoMatriX Wound Matrix | Nextgen Biologics, Inc. Oct 11, 2018 |
| K173920 — LS OIL | J. Morita USA, Inc. Oct 11, 2018 |
| K181578 — DemeTECH PTFE Nonabsorbable Surgical Suture | Demetech Corporation Oct 11, 2018 |
| K180680 — Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray | Laclede, Inc. Oct 11, 2018 |
| K173194 — Temperature Probe | Orantech, Inc. Oct 10, 2018 |
| K180467 — SBG Blue Nitrile Powder Free Medical Examination Glove | Showa Best Glove, Inc. Oct 10, 2018 |
| K182531 — ClotTriever Thrombectomy System | Inari Medical Oct 10, 2018 |
| K180468 — SBG Black Nitrile Powder Free Medical Examination Glove | Showa Best Glove, Inc. Oct 10, 2018 |
| K181863 — Elvie Pump | Chiaro Technology Limited Oct 10, 2018 |
| K182492 — Geminus Volar Distal Radius Plate System | Skeletal Dynamics, LLC Oct 10, 2018 |
| K181774 — Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture | Teleflex Medical Incorporated Oct 10, 2018 |
| K172826 — Cellent Spinal Systems | Jiangsu Trauhui Medical Instrument Co., Ltd. Oct 10, 2018 |
| K181038 — CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) | Cormatrix Cardiovascular, Inc. Oct 10, 2018 |
| K182070 — BioHorizons Tapered IM Implants | BioHorizons Implant Systems, Inc. Oct 10, 2018 |
| K182289 — Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Baoan Medical Supplies Co., Ltd. Oct 10, 2018 |
| K181517 — Senhance Surgical System | Transenterix, Inc. Oct 9, 2018 |
| K181892 — Ziostation2 | Ziosoft, Inc. Oct 9, 2018 |
| K182490 — Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A Oct 9, 2018 |
| K181818 — Scarlet AL-T | Spineart Oct 9, 2018 |
| K182117 — Vinyl Patient Examination Gloves | Jiangxi Zhonghong Pulin Medical Products Co., Ltd. Oct 6, 2018 |