| K191134 — IB3D ALIF | Medicrea International SA Oct 30, 2019 |
| K192775 — Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri | Stereotaxis, Inc. Oct 30, 2019 |
| K192173 — ROSA ONE Spine application | Medtech S.A Oct 29, 2019 |
| K192133 — Zimmer Biomet Universal Navigation System | Zimmer Biomet Spine, Inc. Oct 29, 2019 |
| K192053 — W Zirconia Implants | Tav Medical , Ltd. Oct 29, 2019 |
| K192121 — Black Diamond Pedicle Screw System | Osseus Fusion Systems Oct 29, 2019 |
| K191925 — MATRx Plus | Zephyr Sleep Technologies Oct 29, 2019 |
| K191855 — EmFace Device | Inmode MD , Ltd. Oct 29, 2019 |
| K192369 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. Oct 29, 2019 |
| K192114 — Game Ready GRPro 2.1 System | Cool Systems, Inc. (Dba Game Ready) Oct 29, 2019 |
| K191385 — BRILLIANT COMPONEER | Coltene/Whaledent AG Oct 29, 2019 |
| K192494 — NexGen Anterior Cervical Plate System | Precision Spine Oct 29, 2019 |
| K192041 — G21 SpaceFlex Hip | G21, S.R.L. Oct 29, 2019 |
| K191862 — Compression Therapy Device Model LGT-2200SP | Guangzhou Longest Science & Technology Co., Ltd. Oct 29, 2019 |
| K192673 — 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company Oct 28, 2019 |
| K180347 — 3d Cage | Fims Co., Ltd. Oct 28, 2019 |
| K192046 — LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set | DiaSorin, Inc. Oct 28, 2019 |
| K182605 — HS AMICA devices family | H.S Hospital Service S.P.A Oct 28, 2019 |
| K191881 — KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun | Kbl GmbH Oct 28, 2019 |
| K192802 — primeMidline Catheters | Pfm Medical, Inc. Oct 28, 2019 |
| K192029 — Straumann PUREloc abutments | Institut Straumann AG Oct 28, 2019 |
| K190624 — EarlyVue VS30 | Philips Medizin Systeme Boeblingen GmbH Oct 27, 2019 |
| K192518 — Reusable Monopolar Active Cord | Us Endoscopy Oct 25, 2019 |
| K191874 — F5 Corpus VS | Permobil AB Oct 25, 2019 |
| K191470 — C-CAT Anaesthesia Catheter kit | Cimpax Aps Oct 25, 2019 |
| K192360 — IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation Oct 25, 2019 |
| K191007 — Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems | Supersonic Imagine Oct 25, 2019 |
| K190847 — REDAPT Blade Augments | Smith & Nephew, Inc. Oct 25, 2019 |
| K190181 — Instruments for LINK MEGASYSTEM-C Family | LinkBio Corp. Oct 25, 2019 |
| K191563 — FILTRAY 2G Disposable Water Filters | Aqua-Tools Oct 25, 2019 |
| K192725 — Cytal Wound Matrix 3-Layer | Acell, Inc. Oct 25, 2019 |
| K192667 — gel-e Flex+ gel OTC | Gel-E, Inc. Oct 25, 2019 |
| K191807 — ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device | ALPCO Oct 25, 2019 |
| K192705 — MiniCap Extended Life PD Transfer Sets | Baxter Healthcare Oct 25, 2019 |
| K192787 — Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System | Dexcom, Inc. Oct 25, 2019 |
| K190221 — IOB Warming Blankets | Iob Medical, Inc. Oct 25, 2019 |
| K191085 — Maverick RNP Assay and Maverick Diagnostic System | Genalyte, Inc. Oct 25, 2019 |
| K192690 — Upgrade Kit MR GUI PRO, MrJ 3300 Plus | Asg Superconductors S.P.A. Oct 24, 2019 |
| K192722 — Padlock Clip defect closure system, Padlock Pro-Select defect closure device | STERIS Corporation Oct 24, 2019 |
| K190556 — Zimmer Biomet Universal Navigation System | Zimmer Biomet Spine, Inc. Oct 24, 2019 |
| K190426 — ALTA Anterior Cervical Corpectomy System | Astura Medical, LLC Oct 24, 2019 |
| K191944 — MU2net | Dosisoft Oct 24, 2019 |
| K190037 — Cronus HP PTA Balloon Catheter | Nipro Medical Corporation Oct 24, 2019 |
| K191812 — ADI Cervical Interbody Fusion Device | Additive Device, Inc. (Adi) D/B/A Restor3D Oct 24, 2019 |
| K192686 — Revolution Maxima, Revolution Ace | Ge Hangwei Medical Systems Co., Ltd. Oct 24, 2019 |
| K192728 — Agnes | Agnes Medical Co., Ltd. Oct 24, 2019 |
| K190349 — MediExpand TL Expandable VBR System | Cmf Medicon Surgical, Inc. Oct 24, 2019 |
| K190632 — Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein | Lenora Glove Pvt , Ltd. Oct 24, 2019 |
| K192678 — Genesys Spine Binary® Lumbar Plate System | Genesys Spine Oct 24, 2019 |
| K191358 — Trident II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics Oct 24, 2019 |