| K192019 — Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 | ABBOTT MEDICAL Nov 8, 2019 |
| K192232 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) | Hartalega NGC Sdn. Bhd. Nov 8, 2019 |
| K182301 — PFC SIGMA Knee System | DePuy Orthopaedics, Inc. Nov 8, 2019 |
| K191282 — PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | Pentax Of America, Inc. Nov 8, 2019 |
| K190998 — BA Pit & Fissure Sealant | Apex Dental Materials, Inc. Nov 8, 2019 |
| K192819 — OEC Elite | Ge Oec Medical Systems, Inc. Nov 8, 2019 |
| K192181 — PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. Nov 7, 2019 |
| K192871 — B. anthracis Real-time PCR Assay | Centers For Disease Control And Prevention Nov 7, 2019 |
| K191026 — MEDIP PRO | Medical IP Co., Ltd. Nov 7, 2019 |
| K192327 — DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile | Synthes (USA) Products, LLC Nov 7, 2019 |
| K190923 — Salem Sump Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth Nov 7, 2019 |
| K190872 — BioGenesis Fertility Lubricant | Good Clean Love, Inc. Nov 7, 2019 |
| K192632 — DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless | Canon, Inc. Nov 7, 2019 |
| K192153 — Portux CAD/CAM Disc | New Stetic, SA Nov 7, 2019 |
| K192891 — Laparoscope Lens Shield Device (LENS) | Medeon Biodesign, Inc. Nov 7, 2019 |
| K190571 — StoneBite and StoneBite scan | Dreve Dentamid GmbH Nov 7, 2019 |
| K191361 — DemeDIOX Barbed Absorbable Surgical Suture | Demetech Corporation Nov 7, 2019 |
| K192948 — EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G | Bard Peripheral Vascular, Inc. Nov 7, 2019 |
| K191564 — Progenikine Concentrating System 25 mL System | Emcyte Corporation Nov 7, 2019 |
| K191466 — SandShark Injectable Anchor (SIA) System | Stimwave Technologies, Inc. Nov 7, 2019 |
| K192729 — Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml | Thermo Fisher Scientific Nov 6, 2019 |
| K191651 — Arthrex Nano SwiveLock Suture Anchor | Arthrex, Inc. Nov 6, 2019 |
| K190003 — Vivid Aligners | Orthodent Laboratory, Inc. Nov 6, 2019 |
| K182463 — Silicone Foley Catheter | Biosensors International Pte, Ltd. Nov 6, 2019 |
| K190335 — GSP Neonatal Total Galactose kit | Perkinelmer, Inc. Nov 6, 2019 |
| K191891 — SOMATOM X.cite | Siemens Medical Solutions USA, Inc. Nov 6, 2019 |
| K182929 — BIO-RAY A-1 Anchor Screw System | Microware Precision Co., Ltd. Nov 6, 2019 |
| K192198 — Conformis Hip System | Conformis, Inc. Nov 6, 2019 |
| K191914 — Thermo Scientific Sensititre ARIS HiQ System | Thermo Fisher Scientific Nov 6, 2019 |
| K190268 — Hydrofera Blue READY - Border | Hydrofera, LLC Nov 6, 2019 |
| K191918 — Thermo Scientific Sensititre ARIS HiQ System | Thermo Fisher Scientific Nov 6, 2019 |
| K190541 — MTS225 and MTS300 Multiple Tray Sterilization Systems | Pmbs, LLC Nov 5, 2019 |
| K192236 — Fitmore Hip Stem | Zimmer GmbH Nov 5, 2019 |
| K191047 — ADI TiDAL Osteotomy Wedge | Additive Device, Inc. (Adi) D/B/A Restor3D Nov 5, 2019 |
| K190144 — MucoPEG | Sunbio, Inc. Nov 5, 2019 |
| K183457 — Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head | Zimmer, Inc. Nov 5, 2019 |
| K190225 — TAP Blood Collection Device | Seventh Sense Biosystems, Inc. Nov 5, 2019 |
| K191292 — Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Anhui Powerguard Technology Co., Ltd. Nov 5, 2019 |
| K190868 — Cleerly Labs | Cleerly, Inc. Nov 5, 2019 |
| K192109 — KOALA | Ib Lab GmbH Nov 5, 2019 |
| K192858 — A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company Nov 5, 2019 |
| K192992 — Suglue 3 | 3M Deutschland GmbH Nov 5, 2019 |
| K192140 — 7D Surgical System | 7D Surgical, Inc. Nov 5, 2019 |
| K192080 — iASSIST Knee System | Orthosoft Inc (D/B/A Zimmer Cas) Nov 5, 2019 |
| K192125 — Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | AtriCure, Inc. Nov 4, 2019 |
| K191160 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics, Inc. Nov 4, 2019 |
| K190013 — WellDoc BlueStar | Welldoc, Inc. Nov 4, 2019 |
| K191304 — EthanZir Zirconia | Besorah Dental Solutions NZ Limited Nov 4, 2019 |
| K192168 — Idys ALIF ZP 3DTi | Clariance, Sas Nov 4, 2019 |
| K190143 — LARS AC Band Device | Corin USA Nov 4, 2019 |