| K182538 — Merit RadialFlo Arterial Catheter | Merit Medical Singapore Pte. , Ltd. Jan 16, 2019 |
| K181540 — Estremo Citieffe Nailing System | Citieffe S.R.L. Jan 16, 2019 |
| K181106 — Powder Free Nitrile Patient Examination Gloves, Blue Color | Jiangsu Dongxin Medical Technology Co., Ltd. Jan 16, 2019 |
| K182489 — 4CIS® Pinehurst Anterior Cervical Plate system | Solco Biomedical Co., Ltd. Jan 16, 2019 |
| K183329 — Laser Hair Therapy | Omm Imports, Inc. D/B/A Zero Gravity Jan 16, 2019 |
| K183474 — Carestream DRX-1 System with DRX Core Detectors | Carestream Health, Inc. Jan 16, 2019 |
| K173847 — Disposable Ultra Reinforced Surgical Gown | Xiantao Rayxin Medical Products Co., Ltd. Jan 16, 2019 |
| K183510 — T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. Jan 16, 2019 |
| K181451 — URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R | Olympus Medical Systems Corp. Jan 16, 2019 |
| K183165 — Pristine Scope | Pristine Surgical Jan 16, 2019 |
| K181071 — SIRA RFA Electrosurgical Device | Innoblative Designs, Inc. Jan 16, 2019 |
| K182478 — Whistler Modular Pedicle Screw System | Evolution Spine, LLC Jan 15, 2019 |
| K181096 — Avenue P Cage System | Zimmer Biomet Spine, Inc. Jan 15, 2019 |
| K182497 — OsteoCool RF Ablation System | Medtronic Sofamor Danek USA, Inc. Jan 15, 2019 |
| K183497 — JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. Jan 15, 2019 |
| K182307 — Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. Jan 14, 2019 |
| K180570 — Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) | Argentum Medical, LLC Jan 14, 2019 |
| K182898 — TenoTac Soft Tissue Fixation System | Paragon 28, Inc. Jan 14, 2019 |
| K183514 — ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. Jan 14, 2019 |
| K182202 — SLEEPAPP | Comfort Acrylics, Inc. Jan 11, 2019 |
| K181805 — UV Phototherapy | Xuzhou Kernel Medical Equipment Co., Ltd. Jan 11, 2019 |
| K180228 — II-Type Intervertebral Spacer | Paonan Biotech Co., Ltd. Jan 11, 2019 |
| K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable | Integra Lifesciences Corp. Jan 11, 2019 |
| K183140 — MTS Tetracycline 0.016 - 256 ug/mL | Liofilchem S.R.L. Jan 11, 2019 |
| K182500 — Catalyst CSR Press-Fit Humeral Components | Catalyst Orthoscience, Inc. Jan 11, 2019 |
| K180229 — RESCAN 700, CALLISTO eye | Carl Zeiss Meditec, AG Jan 11, 2019 |
| K182409 — Applied Tissue Technologies PWD Platform Wound Dressing | Applied Tissue Technologies, LLC Jan 11, 2019 |
| K183467 — Roadrunner Extra Support Wire Guide | Cook Incorporated Jan 11, 2019 |
| K182928 — CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. Jan 11, 2019 |
| K182212 — Geo Staple System | Gramercy Extremity Orthopedics, LLC Jan 11, 2019 |
| K182517 — MULTIX Impact | Siemens Medi Cal Solutions, Inc. Jan 11, 2019 |
| K183031 — ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) | Biomerieux S.A. Jan 11, 2019 |
| K181649 — AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) | Trudell Medical International Jan 11, 2019 |
| K182545 — Tamper Evident Cap with Male Luer Lock | International Medical Industries, Inc. Jan 11, 2019 |
| K180902 — MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly | Medipines Corporation Jan 11, 2019 |
| K182453 — ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) | I-Tech Industries Srl Jan 11, 2019 |
| K181377 — PROSTEP MICA Screw System | Wrightmedicaltechnologyinc Jan 11, 2019 |
| K182421 — Senhance Ultrasonic System | Transenterix, Inc. Jan 11, 2019 |
| K182973 — DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH Jan 11, 2019 |
| K181917 — MTA2.3 MATERIALS | NuSmile, Ltd. Jan 11, 2019 |
| K183137 — uMR 580, uMR 588 | Shanghai United Imaging Healthcare Co., Ltd. Jan 11, 2019 |
| K183616 — HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. Jan 10, 2019 |
| K183011 — Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | Additive Orthopaedics Jan 10, 2019 |
| K182727 — Trident HD Specimen Radiography System | Hologic, Inc. Jan 10, 2019 |
| K182636 — DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jan 10, 2019 |
| K180387 — Infrared Ear Thermometer | Hetaida Technology Co., Ltd. Jan 10, 2019 |
| K182120 — Maxpower Relief | Omron Healthcare, Inc. Jan 10, 2019 |
| K182367 — DIASAFEplusUS | Fresenius Medical Care Renal Therapies Group, LLC Jan 10, 2019 |
| K180837 — CONTEC Oxygen Concentrator | Contec Medical System Co., Ltd. Jan 10, 2019 |
| K182873 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices | ETHICON, Inc. Jan 10, 2019 |