| Venera 508 Deep Vein Thrombosis (DVT) Prevention System (K180389) | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2018-06-29 |
| TubeClear System (K172556) | Actuated Medical, Inc. | 2018-06-29 |
| Ensizor Monopolar Endoscopic Scissors (K180134) | Slater Endoscopy, LLC | 2018-06-29 |
| Proton Positioing and Immobilization Devices (K180021) | Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap | 2018-06-29 |
| CREO® Stabilization System, REVERE® Stabilization System (K181068) | Globus Medical, Inc. | 2018-06-29 |
| Servator B SALF Solution (K180481) | S.A.L.F. Spa | 2018-06-29 |
| MotoCLIP/HiMAX Implant System (K181410) | Crossroads Extremity Systems, LLC | 2018-06-29 |
| Ecolab POU Water Filter (K173164) | Ecolab, Inc. | 2018-06-29 |
| NuVasive Pulse System (K180038) | Nu Vasive, Incorporated | 2018-06-29 |
| Allergan Botox Needle Electrode (K173815) | Natus Manufacturing Limited | 2018-06-29 |
| LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD (K180583) | Richard Wolf Medical Instruments Corporation | 2018-06-28 |
| Sapphire II PRO Balloon Dilatation Catheter (K180921) | Orbusneich Medical Trading, Inc. | 2018-06-28 |
| Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM (K172457) | Deltex Medical Limited | 2018-06-28 |
| TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT (K180562) | Zirkonzahn GmbH | 2018-06-28 |
| FaSet Fixation System (K180729) | Huvexel Co. , Ltd. | 2018-06-28 |
| GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide (K173162) | ETHICON, Inc. | 2018-06-28 |
| Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro (K181121) | Home Well Trading, Ltd. | 2018-06-28 |
| ZMI Self-Adhesive Electrodes (K180865) | Zmi Electronics , Ltd. | 2018-06-28 |
| Angled Tip Ureteral Catheter (K181144) | Cook Incorporated | 2018-06-28 |
| Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator (K181404) | Varian Medical Systems, Inc. | 2018-06-28 |
| Juliet Ti (K181203) | Spineart | 2018-06-28 |
| PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh (K180829) | ETHICON, Inc. | 2018-06-28 |
| KJ ZIRCONIA Implant System (K173116) | Kj Meditech Co., Ltd. | 2018-06-28 |
| ArtiClip LAA Exclusion System (K181474) | AtriCure, Inc. | 2018-06-28 |
| Beacon Advanced CO2 Laser System (K180993) | Omniguide, Inc. | 2018-06-28 |
| Alleye (K180895) | Oculocare Medical AG | 2018-06-27 |
| Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel (K180720) | Medibio USA, LLC | 2018-06-27 |
| HD LifeSciences Cervical IBFD System (K180364) | Hd Lifesciences, LLC | 2018-06-27 |
| OverStitch Endoscopic Suturing System and Accessories (K181141) | Apollo Endosurgery | 2018-06-27 |
| uDR 592h, uDR 596i (K181413) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-27 |
| Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (K180646) | Halyard Health | 2018-06-27 |
| Shockwave Medical Intravascular Lithotripsy (IVL) System (K180454) | Shockwave Medical, Inc. | 2018-06-27 |
| CALLISTO eye (K180858) | Carl Zeiss Meditec, AG | 2018-06-27 |
| SecurAcath (K180769) | Interrad Medical, Inc. | 2018-06-26 |
| Uterine Manipulator (K172846) | Beijing Hangtian Kadi Technology R&D Institute | 2018-06-26 |
| NeuMoDx GBS Assay (K173725) | Neumodx Molecular, Inc. | 2018-06-26 |
| Range (Denali and Mesa) Spinal Systems (K181119) | K2m, Inc. | 2018-06-26 |
| DenSeeMammo (K173574) | Statlife | 2018-06-26 |
| Express 4 Sleep appliance/CPAP Sidekick appliance (K173856) | Moses Appliances, LLC | 2018-06-26 |
| Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay (K181438) | Diazyme Laboratories, Inc. | 2018-06-26 |
| IV Administration Set (K173361) | B.Braun Medical, Inc. | 2018-06-26 |
| QUANTA Flash HMGCR Reagents (K180975) | Inova Diagnostics, Inc. | 2018-06-25 |
| EVOL® ha-C Cervical Interbody Fusion System (K180674) | Cutting Edge Spine, LLC | 2018-06-25 |
| SpaceOAR System (K181465) | Augmenix, Inc. | 2018-06-25 |
| Vscan Extend (K180995) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-06-25 |
| EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay (K181329) | Phadia AB | 2018-06-25 |
| Navigation Instruments (K180690) | Globus Medical, Inc. | 2018-06-25 |
| SafePath Suturing System (K180701) | Safepath Medical, Inc. | 2018-06-25 |
| Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA (K181230) | Largan Medical Co., Ltd. | 2018-06-25 |
| SPIRA Open Matrix LLIF (K180724) | Camber Spine Technologies, LLC | 2018-06-25 |
| MONET™ Anterior Cervical Interbody Fusion Cage System (K172788) | Ctl Medical Corporation | 2018-06-25 |
| Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) (K180950) | Terumo Cardiovascular Systems Corporation | 2018-06-22 |
| MIS Internal Hex Dental Implant System (K180282) | Mis Implants Technologies , Ltd. | 2018-06-22 |
| OSSEODUO Shaver and Drill System (K173066) | Bien-Air Surgery SA | 2018-06-22 |
| FIJI SUN FLUORESCENT TANNING UNIT (K151721) | Kdb Inc. (Dba) Sperti Sunlamp | 2018-06-22 |
| Vios Monitoring System™ Model 2050 (K172586) | Vios Medical, Inc. | 2018-06-22 |
| MIM - SPECTRA Quant (K180815) | Mim Software, Inc. | 2018-06-22 |
| A3 Total Knee System (K180493) | Beijing AK Medical Co., Ltd. | 2018-06-22 |
| Ellipsys Vascular Access System (DEN170004) | Avenu Medical, Inc. | 2018-06-22 |
| OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test (K181436) | SEKISUI Diagnostics, LLC | 2018-06-22 |
| Shear Wave Quantificational Ultrasound Diagnostic System (K173595) | Wuxi Hisky Medical Technologies Co., Ltd. | 2018-06-22 |
| Life Spine Lumbar Fixation System (SENTRY) (K180166) | Life Spine, Inc. | 2018-06-22 |
| everlinQ endoAVF System (DEN160006) | Tva Medical, Inc. | 2018-06-22 |
| Wireless Pain Relieve Device (K180331) | Shenzhen Dongdixin Technology Co., Ltd. | 2018-06-22 |
| AIROS 6 Sequential Compression Device (K172770) | Airos Medical, Inc. | 2018-06-22 |
| iSLEEVE Introducer Set (K180785) | Boston Scientific Corporation | 2018-06-22 |
| Advance Biliary Balloon Catheter (K173414) | Cook Incorporated | 2018-06-22 |
| AIROS 8 Sequential Compression Device (K172779) | Airos Medical, Inc. | 2018-06-22 |
| gel-e Flex (K180152) | Gel-E, Inc. | 2018-06-22 |
| Perfadex Plus (K170826) | Xvivo Perfusion AB | 2018-06-22 |
| BioPlex 2200 25-OH Vitamin D Kit (K180577) | Bio-Rad Laboratories | 2018-06-22 |
| VaPro 2 Intermittent Catheter (K180824) | Hollister Incorporated | 2018-06-22 |
| UV Lamps for Sunlamp Products (K180581) | Feilo Sylvania Germany GmbH | 2018-06-22 |
| Elecsys CA 15-3 II (K181492) | Roche Diagnostics | 2018-06-22 |
| Knotless SutureTak Anchors (K180594) | Arthrex, Inc. | 2018-06-22 |
| IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm (K181051) | Shape Memory Medical | 2018-06-22 |
| Eclipse II (K180809) | Carestream Health, Inc. | 2018-06-21 |
| 0.9% Sodium Chloride Injection, USP (K173348) | Medline Industries, Inc. | 2018-06-21 |
| Straumann BLX Surgical Cassette (K180791) | Institut Straumann AG | 2018-06-21 |
| HOMED Mesh Nebulizer (K170886) | Shenzhen Homed Medical Device Co., Ltd. | 2018-06-21 |
| Kopac Sterile Needle (K172483) | Poonglim Pharmatech, Inc. | 2018-06-21 |
| LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (K181085) | Covidien | 2018-06-21 |
| BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software (K173028) | Healthstats International Pte. , Ltd. | 2018-06-21 |
| DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional (K172975) | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2018-06-21 |
| Integra TITAN Reverse Shoulder System (K173717) | Integra LifeSciences Corporation | 2018-06-21 |
| Pure Vu System (K181437) | Motus GI Medical Technologies , Ltd. | 2018-06-21 |
| Televere Digital Dental Imaging System (K181358) | Televere Systems, Inc. | 2018-06-20 |
| Visura Technologies TEECAD System (K180911) | Visura Technologies, LLC | 2018-06-20 |
| Atlas Percussion Adjusting Instrument (K172536) | Spinalight, Inc. | 2018-06-20 |
| Swiss LithoClast Trilogy (K181364) | E.M.S Electro Medical Systems S.A | 2018-06-20 |
| Fracture and Correction System (K180377) | In2bones USA, LLC | 2018-06-20 |
| SuperNO2VA Et Device (K173147) | Revolutionary Medical Devices, Inc. | 2018-06-20 |
| HairMax Laser (K180885) | Lexington International, LLC | 2018-06-20 |
| Cartiva SCI Disposable Instrumentation Set (K181348) | Cartiva, Inc. | 2018-06-20 |
| VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) (K181368) | bioMerieux, Inc. | 2018-06-20 |
| Penumbra System (K180008) | Penumbra, Inc. | 2018-06-20 |
| Balanced Knee Revision System - Offset Junction Box (K180743) | Ortho Development Corporation | 2018-06-20 |
| Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus (K173139) | Bionime Corporation | 2018-06-19 |
| SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device (K173316) | Transmed7, LLC | 2018-06-19 |
| PICOPLUS Laser System (K173700) | Lutronic Corporation | 2018-06-19 |