| EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern (K172244) | Euroimmun Us, Inc. | 2018-04-20 |
| PICO Single Use Negative Pressure Wound Therapy System (K180618) | Smith & Nephew Medical Limited | 2018-04-20 |
| SafetyFix EasyOut System (K180753) | Safetyfix Medical Technologies, Inc. | 2018-04-20 |
| Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (K180451) | Stryker Sustainability Solutions | 2018-04-20 |
| Panoramic Oxygen Mask (POM) (K172365) | Pom Medical, LLC | 2018-04-19 |
| XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) (K172887) | Guangzhou Xinbo Electronic Co., Ltd. | 2018-04-19 |
| Isolette 8000 plus (K172154) | Draeger Medical Sytems, Inc. | 2018-04-19 |
| syngo.MR Applications (K180336) | Siemens Medical Solutions USA, Inc. | 2018-04-19 |
| VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set (K173757) | Greiner Bio-One Na, Inc. | 2018-04-19 |
| Medtronic Model 53401 External Pulse Generator (EPG) (K180873) | Medtronic, Inc. | 2018-04-19 |
| Embozene Color-Advanced Microspheres (K180102) | Boston Scientific | 2018-04-19 |
| 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (K180007) | Creagh Medical, Ltd. | 2018-04-19 |
| SuperSlyde Personal Lubricant (K172306) | Icm Pharma Pte, Ltd. | 2018-04-19 |
| Zenith Flex System (K172167) | Inneuroco, Inc. | 2018-04-19 |
| CoaguChek XS Plus System (K180684) | Roche Diagnostics | 2018-04-19 |
| Balloon Catheter and Balloon Ureteral Dilator Set (K172588) | Cook Incorporated | 2018-04-19 |
| AViTA Radar Thermo NT16 Series IR Thermometer (K172427) | Avita Corporation | 2018-04-19 |
| MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments (K173472) | Medacta International S.A. | 2018-04-19 |
| iSchemaView RAPID (K172477) | Ischemaview, Inc. | 2018-04-19 |
| EV-804 OTC Pain Relief TENS (K172919) | Everyway Medical Instruments Co.,Ltd | 2018-04-19 |
| encevis (K171720) | Ait Austrian Institute of Technology GmbH | 2018-04-19 |
| Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) (K180576) | Lpi, Inc. | 2018-04-19 |
| Synermed Opiate Enzyme Immunoassay (K172416) | Infrared Laboratory Systems, LLC (Dba Synermed) | 2018-04-19 |
| CoaguChek XS Pro System (K180693) | Roche Diagnostics | 2018-04-19 |
| Ultramatrix EUS Balloon (K180731) | United States Endoscopy Group, Inc. (Us Endoscopy) | 2018-04-19 |
| TENS device-EmeTerm, CinvStop (K172478) | Wat Medical Technology (Ningbo) Co., Ltd. | 2018-04-19 |
| Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE (K172598) | Itw Contamination Control Electronics | 2018-04-19 |
| HALF DOME Posterior Lumbar Interbody System (K172947) | Astura Medical | 2018-04-18 |
| OVOMotion Shoulder Arthroplasty System (K173964) | Arthrosurface, Inc. | 2018-04-18 |
| Stryker Universal Select Sterilization Tray System (K173615) | Paragon Medical | 2018-04-18 |
| RAILWAY Sheathless Access System (K180081) | Cordis Corporation | 2018-04-18 |
| ENZA-A Titanium ALIF (K173432) | Camber Spine Technologies | 2018-04-18 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K172880) | Microlife Intellectual Property GmbH | 2018-04-18 |
| Genistrong (K180836) | Genicon, Inc. | 2018-04-18 |
| Wingman 35 Crossing Catheter (K173661) | Reflow Medical, Inc. | 2018-04-18 |
| VERTEX™ Reconstruction System (K180851) | Medtronic Sofamor Danek USA, Inc. | 2018-04-18 |
| DiLumen C2; DiLumen Tool Mount (K173317) | Lumendi, LLC | 2018-04-17 |
| NM/CT 850, NM/CT 860 (K173816) | GE Healthcare | 2018-04-17 |
| KARL STORZ ICG Imaging System (K180146) | Karl Storz Endoscopy America, Inc. | 2018-04-17 |
| ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System (K180416) | Cardiovascular Systems, Inc. | 2018-04-17 |
| PreludeSYNC DISTAL Radial Compression System (K180723) | Merit Medical Systems, Inc. | 2018-04-17 |
| Diode laser hair removal device (K180353) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2018-04-17 |
| Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System (K180078) | Innovasis, Inc. | 2018-04-17 |
| THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (K172610) | Olympus Medical Systems Corp. | 2018-04-17 |
| Fusion OMNI Sphincterotome (K172288) | Wilson-Cook Medical Inc./Cook Endoscopy | 2018-04-17 |
| FOCUS Pedicle Screw System (K180458) | Nvision Biomedical Technologies, LLC | 2018-04-17 |
| WR19 System (K172735) | Zeto, Inc. | 2018-04-17 |
| Aesculap Slim Clip Applier (K180914) | Aesculap, Inc. | 2018-04-17 |
| Penumbra Coil 400, Ruby Coil System, POD System (K173614) | Penumbra, Inc. | 2018-04-17 |
| FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device (K180588) | Teleflex Medical | 2018-04-17 |
| CardiMax Electrocardiograph (K173226) | Fukuda Denshi USA, Inc. | 2018-04-16 |
| GDT-1000 System (K180096) | Acuvu, Inc. | 2018-04-16 |
| SOZO (K180126) | ImpediMed Limited | 2018-04-16 |
| ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut (K173726) | Phadia AB | 2018-04-16 |
| Hemoclip (K172727) | Hangzhou AGS MedTech Co., Ltd. | 2018-04-16 |
| Mediant Anterior Cervical Plating System (K173935) | Intelligent Implant Systems, LLC | 2018-04-16 |
| Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set (K171603) | Cook Incorporated | 2018-04-16 |
| Pivet and Soft-Pass Embryo Transfer Catheter Sets (K173103) | Cook Incorporated | 2018-04-13 |
| uMI 780 PET/CT System (K172143) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-04-13 |
| Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) (K180305) | Aquilabs Us, LLC | 2018-04-13 |
| KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System (K170463) | I-Sens, Inc. | 2018-04-13 |
| Piezosurgery White (K171326) | Mectron S.P.A. | 2018-04-13 |
| Voyant Open Fusion Device (K180699) | Applied Medical Resources Corporation | 2018-04-13 |
| SmartGrid (K180667) | Carestream Health, Inc. | 2018-04-13 |
| SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device (K173606) | SeaSpine Orthopedics Corporation | 2018-04-13 |
| mCare Powder-free Blue Nitrile Examination Gloves (K172930) | Mercator Medical (Thailand), Ltd. | 2018-04-13 |
| D-Actor 200 Vibration Massage System (K173692) | Storz Medical AG | 2018-04-13 |
| Reza Band, Reflux Band (K173934) | Somna Therapeutics, LLC | 2018-04-13 |
| SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO (K173632) | Siemens Medical Solutions USA, Inc. | 2018-04-13 |
| SonoSite iViz Ultrasound System (K180704) | FUJIFILM Sonosite, Inc. | 2018-04-13 |
| LIGHTSonic BUBM (K170761) | Lightmed USA, Inc. | 2018-04-13 |
| U60 Diagnostic Ultrasound System (K180408) | Edan Instruments, Inc. | 2018-04-13 |
| VisuMax Femtosecond Laser (K173371) | Carl Zeiss Meditec, Inc. | 2018-04-13 |
| Best Instruminal Applicator (K162499) | Best Medical International, Inc. | 2018-04-13 |
| ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 (K170901) | Biosystems S.A. | 2018-04-13 |
| Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono (K171562) | Dreve Dentamid GmbH | 2018-04-13 |
| JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire (K180795) | Boston Scientific | 2018-04-12 |
| Admiral Xtreme (K173515) | Medtronic Vascular | 2018-04-12 |
| Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device (K180689) | STERIS Corporation | 2018-04-12 |
| C3 Wave System (K180567) | Medical Components, Inc. (dba MedComp) | 2018-04-12 |
| 48CH Head Coil (K180666) | Ge Healthcare Coils (Usa Instruments, Inc.) | 2018-04-12 |
| Straub Endovascular System (K172315) | Straub Medical AG | 2018-04-12 |
| Uroview FD II (K180651) | Pausch Medical GmbH | 2018-04-12 |
| StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing (K172155) | Statguard, LLC | 2018-04-12 |
| ZED Link (K180549) | Zed Technologies | 2018-04-12 |
| Atellica IM Folate Assay (K172201) | Siemens Healthcare Diagnostics, Inc. | 2018-04-12 |
| Reform® POCT System (K172495) | Precision Spine, Inc. | 2018-04-11 |
| Corin TriFit CF Hip Stem (K173880) | Corin U.S.A. Limited | 2018-04-11 |
| IDx-DR (DEN180001) | Idx, LLC | 2018-04-11 |
| Inno-Hydrowire (K172187) | Suzhou Innomed Medical Device Co., Ltd. | 2018-04-11 |
| Riva Star (K172047) | Sdi Limited | 2018-04-11 |
| Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter (K173686) | Cook Incorporated | 2018-04-11 |
| Rafugen DBM (K180121) | Cellumed Co., Ltd. | 2018-04-11 |
| Stablyx CMC Arthroplasty Implant System (K180744) | Skeletal Dynamics, LLC | 2018-04-11 |
| PET Digital Gating (K180318) | Ge Medical Systems, LLC | 2018-04-11 |
| HEALIX ADVANCE Anchor with DYNACORD Suture (K173859) | Medos International SARL | 2018-04-11 |
| s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System (K173860) | Volcano Corporation | 2018-04-11 |
| NAJA™ Ligament Correction System (K172206) | Cousin Biotech Sas | 2018-04-10 |
| Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal (K180398) | Alcon Laboratories, Inc. | 2018-04-10 |
| Imager II Urology Torque Catheter (K180530) | Boston Scientific Corporation | 2018-04-10 |