| K180339 — Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL | Liofilchem S.R.L. Apr 4, 2018 |
| K180088 — TrapLiner catheter | Vascular Solutions, Inc. Apr 4, 2018 |
| K173079 — Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 | Philips Medical Systems Nederland B.V. Apr 4, 2018 |
| K180342 — SYSTEM 1E Liquid Chemical Sterilant Processing System | Steris Corporations Apr 4, 2018 |
| K180571 — GammaPod | Xcision Medical Systems, LLC Apr 4, 2018 |
| K180595 — SciMoCa | Radialogica, LLC Apr 4, 2018 |
| K173074 — ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor | Stryker Apr 4, 2018 |
| K172141 — Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. Apr 4, 2018 |
| K173597 — Scenium VE20 Software | Siemens Medical Solutions USA, Inc. Apr 4, 2018 |
| K180561 — MobileX Portable X-ray System | Denterprise International, Inc. Apr 4, 2018 |
| K173699 — The Pump by Babyation | Babyation, LLC Apr 4, 2018 |
| K172963 — Master-Frank N95 Particulate Respirator | Master & Frank Enterprise Co., Ltd. Apr 4, 2018 |
| K172239 — SIMPLANT 18 | Dentsply Sirona Apr 4, 2018 |
| K173072 — Algidex Ag Silver Alginate Wound Dressing | Deroyal Industries, Inc. Apr 4, 2018 |
| K180637 — leva Pelvic Floor Trainer | Renovia, Inc. Apr 4, 2018 |
| K173958 — OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens | Visco Vision, Inc. Apr 3, 2018 |
| K180320 — dpl IIa Panel | Led Technologies, Inc. Apr 3, 2018 |
| K173506 — LigaPASS | Medicrea International SA Apr 3, 2018 |
| K180566 — Unite Connect for Clinical Systems | Ascom Sweden AB Apr 3, 2018 |
| K172630 — Kisses Plus Implant System | Achimhai Medical Corporation Apr 3, 2018 |
| K180597 — AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | Lumenis, Ltd. Apr 3, 2018 |
| K173885 — Genesys Spine Binary Lumbar Plate System | Genesys Spine Apr 3, 2018 |
| DEN170047 — Curetis Unyvero LRT Application | Curetis GmbH Apr 3, 2018 |
| K180503 — PRECICE STRYDE System | Nuvasive Specialized Orthopedics, Inc. Apr 3, 2018 |
| K180677 — Surefire Spark Infusion System | Surefire Medical, Inc. Apr 3, 2018 |
| K172635 — High-Flo Silver Polyethylene Catheter | Cook Incorporated Apr 3, 2018 |
| K180243 — Infinity-Lock Button System | Xiros, Ltd. Apr 3, 2018 |
| K173362 — DSM Biomedical Calcium Phosphate Cement | Kensey Nash Corporation Dba Dsm Biomedical Apr 3, 2018 |
| K173639 — Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax | Siemens Medi Cal Solutions, Inc. Apr 2, 2018 |
| K173896 — Microcyn Antimicrobial Hydrogel | Sonoma Pharmaceuticals, Inc. Apr 2, 2018 |
| K171692 — Instrument basket, for EndoEYE | Olympus Winter & Ibe GmbH Apr 2, 2018 |
| K172382 — GC Fuji Direct | GC America, Inc. Apr 2, 2018 |
| K173669 — K-D Balance | King-Devick Technologies, Inc. Apr 2, 2018 |
| K180210 — CREO® Stabilization System | Globus Medical, Inc. Apr 2, 2018 |
| K180586 — Varian Head Frame | Varian Medical Systems, Inc. Apr 2, 2018 |
| K173517 — RADspeed fit | Shimadzu Corporation Mar 30, 2018 |
| K171988 — Performer Guiding Sheath | Cook Incorporated Mar 30, 2018 |
| K171952 — Dimesol Tubing Sets for Hemodialysis | Dimesol, Inc. Mar 30, 2018 |
| K173630 — SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence | Siemens Medical Solutions USA, Inc. Mar 30, 2018 |
| K180194 — SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. Mar 30, 2018 |
| K171997 — Mandril Wire Guide | Cook Incorporated Mar 30, 2018 |
| K171857 — AMSure® Enteral Feeding Syringe with ENFit Tip | Amsino International, Inc. Mar 30, 2018 |
| K173548 — Merit Pursue Microcatheter | Merit Medical Systems, Inc. Mar 30, 2018 |
| K173379 — Straumann Variobase for Crown AS | Institut Straumann AG Mar 30, 2018 |
| K173789 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB Mar 30, 2018 |
| K172312 — eego amplifiers | Eemagine Medical Imaging Solutions GmbH Mar 30, 2018 |
| K172246 — OLYMPUS URF-V2/V2R | Olympus Medical Systems Corp. Mar 30, 2018 |
| K180538 — gammaCore Sapphire | Electrocore, LLC Mar 30, 2018 |
| K173617 — MAGNETOM Vida with Compressed Sensing GRASP-VIBE | Siemens Medical Solutions USA, Inc. Mar 30, 2018 |
| K173029 — Nipro Syringe | Nipro Medical Corporation Mar 30, 2018 |