| K191844 — Fidmi Low Profile Enteral Feeding Device | Fidmi Medical, Ltd. Sep 30, 2019 |
| K191524 — Visalys Tooth Primer | Kettenbach GmbH & Co. KG Sep 29, 2019 |
| K192421 — EpiFaith Syringe | Flat Medical Co., Ltd. Sep 27, 2019 |
| K191444 — Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir | Medtronic, Inc. Sep 27, 2019 |
| K192352 — MiniMAX | Medacta International S.A. Sep 27, 2019 |
| K190059 — CEREC Guides | Dentsply Sirona Sep 27, 2019 |
| K191074 — Sorrento Bone Graft Substitute | Xenco Medical, LLC Sep 27, 2019 |
| K181606 — Precision Spine Navigation Instrumentation | Precision Spine, Inc. Sep 27, 2019 |
| K190076 — Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems | Cepheid Sep 27, 2019 |
| K191747 — FUJIFILM Duodenoscope Model ED-580XT | Fujifilm Corporation Sep 27, 2019 |
| K182722 — XLR8 Abdominal Wound Dressing Kit | Genadyne Biotechnologies Sep 27, 2019 |
| K190024 — Smart-C | Turner Imaging Systems, Inc. Sep 27, 2019 |
| K180001 — Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant | Embla Systems Sep 27, 2019 |
| K192112 — FlexBand Plus | International Life Sciences Sep 27, 2019 |
| K192129 — ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens | Clearlab SG Pte, Ltd. Sep 27, 2019 |
| K192368 — CATSmart | Fresenius Kabi AG Sep 27, 2019 |
| K192050 — ETEST Eravacycline (ERV) (0.002 32 µg/mL) | Biomerieux S.A. Sep 27, 2019 |
| K191521 — Radiance 330 Proton Beam Therapy System | Protom International Holding Corporation Sep 27, 2019 |
| K191530 — StoneChecker | Imaging Biometrics, LLC Sep 26, 2019 |
| K191748 — Genesys Spine Sacroiliac Joint Fusion System | Genesys Spine Sep 26, 2019 |
| K192195 — Sterile Dilator | Galt Medical Corp. Sep 26, 2019 |
| K192371 — BioZorb SP Marker | Focal Therapeutics Sep 26, 2019 |
| K192364 — GXR-Series Diagnostic X-Ray System | DRGEM Corporation Sep 26, 2019 |
| K190454 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff | Hartalega NGC Sdn. Bhd. Sep 26, 2019 |
| K191537 — eCarbon IBDs | Back 2 Basics Direct, LLC Sep 26, 2019 |
| K191545 — Exogenesis Hernia Mesh | Exogenesis Corporation Sep 26, 2019 |
| K192391 — Spectralis HRA+OCT and Variants | Heidelberg Engineering GmbH Sep 26, 2019 |
| K190466 — PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate | Shen Wei USA, Inc. Sep 26, 2019 |
| K191336 — PRECICE System | Nuvasive Specialized Orthopedics, Inc. Sep 26, 2019 |
| K190029 — Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd Sep 26, 2019 |
| K192435 — NuVasive NuvaLine | Nu Vasive, Incorporated Sep 26, 2019 |
| K182009 — Dia-Proseal | DiaDent Group International Sep 26, 2019 |
| K190199 — SepaSperm Washing Solution, SepaSperm Solution | Kitazato Corporation Sep 26, 2019 |
| K190022 — SafeBreath Filter Mouthpiece | MD Diagnostics Limited Sep 25, 2019 |
| K183190 — NuStat | Beeken Biomedical, LLC Sep 25, 2019 |
| K192011 — PhoeniX | Sedecal., Sa. Sep 25, 2019 |
| K183687 — LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. Sep 25, 2019 |
| K190323 — Aloe Glide Lubricant | Desert Harvest, Inc. Sep 25, 2019 |
| K190536 — Mediracer NCS | Mediracer OY Sep 25, 2019 |
| K183675 — 3D Visualization System | Scivita Medical Technology Co., Ltd. Sep 25, 2019 |
| K192102 — Thermoplastic Masks | Aktina Medical Corporation Sep 25, 2019 |
| K190875 — EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) | D.O.R.C. Dutch Ophthalmic Research Center (International) Sep 25, 2019 |
| K191791 — TranS1 Interbody Fusion System | Trans1 Sep 25, 2019 |
| K191765 — OMNI TiN Coated Apex Knee System | Omni Life Science, Inc. Sep 25, 2019 |
| K191742 — ARIES MRSA Assay | Luminex Corporation Sep 25, 2019 |
| K191998 — Mako Total Hip Application, Mako Total Knee Application | Mako Surgical Corp. Sep 24, 2019 |
| K190574 — Patient Assistant Model PA97000 | Medtronic, Inc. Sep 24, 2019 |
| K192354 — Innovasis Gibralt Spine System | Innovasis, Inc. Sep 24, 2019 |
| K191718 — Buhlmann fCAL turbo and CALEX Cap | Buhlmann Laboratories AG Sep 24, 2019 |
| K192010 — SmoothSkin BARE+ | Cyden Limited Sep 24, 2019 |