| K180037 — Beacon EUS Access System | Covidien, LLC Apr 26, 2018 |
| K180514 — VERITON NM | Spectrum Dynamics Medical, Ltd. Apr 25, 2018 |
| K180563 — syngo.plaza | Siemens Healthcare GmbH Apr 25, 2018 |
| K173782 — UNiD Patient Specific 3D printed cage | Medicrea International SA Apr 25, 2018 |
| K173143 — Phasix ST Mesh | C.R. Bard, Inc. Apr 25, 2018 |
| K162525 — Oniko nail brace | Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti Apr 25, 2018 |
| K180002 — Rampart One Lumbar Interbody Fusion Device | Spineology, Inc. Apr 25, 2018 |
| K180379 — RayStation 7 | RaySearch Laboratories AB (PUBL) Apr 25, 2018 |
| K173321 — StimuQuik 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1) Peripheral Nerve Block Needle | Teleflex Medical Apr 25, 2018 |
| K180616 — OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens | Contamac, Ltd. Apr 25, 2018 |
| K180257 — InCore® Lapidus System | Nextremity Solutions, Inc. Apr 25, 2018 |
| K173865 — trophon2 | Nanosonics Limited Apr 24, 2018 |
| K180277 — Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter | Smith & Nephew, Inc. Apr 24, 2018 |
| K180206 — neuromate Gen III | Renishaw Mayfield Sarl Apr 24, 2018 |
| K180225 — GSI Viewer with GSI Fat Option | GE Medical Systems SCS Apr 24, 2018 |
| K180222 — Reaxon Plus | Medovent GmbH Apr 24, 2018 |
| K180030 — TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | Medtronic, Inc. Apr 24, 2018 |
| K172464 — XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium Apr 24, 2018 |
| K172768 — ZOOM | Zetta Medical Technologies, LLC Apr 24, 2018 |
| K162314 — IMACTIS CT-Navigation system | Imactis, Sas Apr 24, 2018 |
| K180252 — Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank | Crown Porcelain Dental Technology Co., Ltd. Apr 24, 2018 |
| K172699 — Agile Nail | Orthofix Srl Apr 23, 2018 |
| K172393 — Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. Apr 23, 2018 |
| K173519 — 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader | 3M Company Apr 23, 2018 |
| K171917 — Frova Intubating Introducer | Cook Incorporated Apr 23, 2018 |
| K173715 — AlertWatch:OB | Alertwatch, Inc. Apr 23, 2018 |
| K180090 — Cure Lumbar Plate System | Meditech Spine, LLC Apr 23, 2018 |
| K172396 — EnSite Velocity Cardiac Mapping System v5.2 | St Jude Medical Apr 23, 2018 |
| K171883 — Sysmex UF-5000 Fully Automated Urine Particle Analyzer | Sysmex America, Inc. Apr 23, 2018 |
| K173842 — da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. Apr 23, 2018 |
| K180499 — Reprocessed LigaSure Maryland Jaw Sealer/Divider | Stryker Sustainability Solutions Apr 23, 2018 |
| K172329 — Patient Status Engine | Isansys Lifecare, Ltd. Apr 23, 2018 |
| K180451 — Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider | Stryker Sustainability Solutions Apr 20, 2018 |
| K180765 — Televere Podiatry X-Ray System HF | Televere Systems, Inc. Apr 20, 2018 |
| K180618 — PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited Apr 20, 2018 |
| K173962 — Viamo c100 TUS-VC100 Diagnostic Ultrasound System | Toshibamedical Systems Corporation Apr 20, 2018 |
| K180304 — Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. Apr 20, 2018 |
| K171443 — Etherea MX | Vydence Medical Industria E Comercio Ltda Apr 20, 2018 |
| K173855 — Sharpsite AC Rigid Endsocope | Medtronic Xomed, Inc. Apr 20, 2018 |
| K180161 — Viz CTP | Viz. Ai, Inc. Apr 20, 2018 |
| K172252 — EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | Euroimmun Us, Inc. Apr 20, 2018 |
| K180753 — SafetyFix EasyOut System | Safetyfix Medical Technologies, Inc. Apr 20, 2018 |
| DEN170081 — MALDI Biotyper CA System | Bruker Daltonik GmbH Apr 20, 2018 |
| K180750 — World Knee System | Signature Orthopaedics Pty, Ltd. Apr 20, 2018 |
| K172244 — EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | Euroimmun Us, Inc. Apr 20, 2018 |
| K173258 — Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy | Pt. Medisafe Technologies Apr 20, 2018 |
| K180322 — Si-Hy (olifilcon B) color silicone hydrogel soft contact lens | Visco Vision, Inc. Apr 20, 2018 |
| K172511 — Hickman TriFusion Catheter | C.R. Bard, Inc. Apr 20, 2018 |
| K180140 — ProFlex Laser Fibers | Innovaquartz, LLC Apr 20, 2018 |
| DEN170010 — LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay | Lin-Zhi International, Inc. Apr 20, 2018 |