| K192598 — Bashir S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. Oct 18, 2019 |
| K190342 — BIAFINE Topical Cream | Bausch Health Americas Incorporated Oct 18, 2019 |
| K183274 — RTHawk, HeartVista Cardiac Package | Heartvista, Inc. Oct 18, 2019 |
| K192325 — Quantum Blood and Fluid Warming System | Life Warmer, Inc. Oct 18, 2019 |
| K181896 — LIPOcel | Jeisys Medical, Inc. Oct 18, 2019 |
| K192441 — Arthrex SwiveLock Anchors | Arthrex, Inc. Oct 17, 2019 |
| K192175 — On Call Express II Blood Glucose Monitoring System | ACON Laboratories, Inc. Oct 17, 2019 |
| K182073 — BcSs-PICNI-2000 Sensor | Braincare Desenvolvimento E Inovacao Tecnologica S.A. Oct 17, 2019 |
| K192316 — Matrix HA PEEK Cervical Implant System | Sapphire Medical Group Oct 17, 2019 |
| K192239 — WavelinQ Plus EndoAVF System | C.R. Bard, Inc. Oct 17, 2019 |
| K192566 — Reach and CQ'ENCE Circular Staplers | Reach Surgical, Inc. Oct 17, 2019 |
| K192556 — Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. Oct 17, 2019 |
| K183503 — EasyMark Tissue Marker | Inrad, Inc. Oct 17, 2019 |
| K190162 — SmartCeph | Ortho2, LLC Oct 17, 2019 |
| K192455 — Merge PACS | Merge Healthcare Incorporated Oct 17, 2019 |
| K191216 — Voxel Dosimetry v1.0 | Hermes Medical Solutions AB Oct 17, 2019 |
| K191942 — MT One Diamond | M&T S.R.L. Oct 17, 2019 |
| K191653 — Freestyle Flex | Medela AG Oct 17, 2019 |
| K190102 — DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System | Osprey Medical, Inc. Oct 17, 2019 |
| K192250 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL | Thermo Fisher Scientific Oct 16, 2019 |
| K191771 — SECURE Screw | A.M. Surgical, Inc. Oct 16, 2019 |
| K192512 — Focus 35C Detector, Trimax 35C Detector | Iray Technology Taicang , Ltd. Oct 16, 2019 |
| K190486 — Pitkar External Fixation System | S.H.Pitkar Orthotools Pvt. , Ltd. Oct 16, 2019 |
| K191493 — Ventripoint Medical System Plus (VMS+) 3.0 | Ventripoint Diagnostics , Ltd. Oct 16, 2019 |
| K192541 — DigiX FDX | Allengers Medical Systems Limited Oct 16, 2019 |
| K190953 — Arthrex Minimally Invasive Ankle Fusion Plate | Arthrex, Inc. Oct 16, 2019 |
| K192194 — TotalShield II Surgical Helmet System | Zimmer Surgical, Inc. Oct 15, 2019 |
| K190149 — Vial Adapter Ø20 mm | Avenir Performance Europeenne Medical (Apem) Oct 15, 2019 |
| K191672 — NuFACE Mini Device | Carol Cole Company Dba Nuface Oct 15, 2019 |
| K191326 — Arthrex Mini Comprehensive Fixation System 1.4mm & 1.6mm Module | Arthrex, Inc. Oct 15, 2019 |
| K191251 — Infared Thermometer | Shenzhen Calibeur Industries Co., Ltd. Oct 15, 2019 |
| K192434 — DualX Lumbar Intervertebral Body Fusion Device | Amplify Surgical, Inc. Oct 15, 2019 |
| K190840 — Medtronic Transportation / Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. Oct 15, 2019 |
| K190937 — Echelon Endopath Staple Line Reinforcement | Ethicon Endo-Surgery, LLC Oct 14, 2019 |
| K191480 — Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) | Trigg Laboratories, Inc. D/B/A Wet International Oct 11, 2019 |
| K190713 — F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) | Fisher & Paykel Healthcare, Ltd. Oct 11, 2019 |
| K192214 — CarboClear VBR System | CarboFix Orthopedics , Ltd. Oct 11, 2019 |
| K191684 — MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System | Integra LifeSciences Corporation Oct 11, 2019 |
| K191181 — NXPRO Neuromuscular Electrical Stimulation Device | Neux Technologies, Inc. Oct 11, 2019 |
| K183674 — Electronic Pulse Stimulator | Shenzhen Leading Perfection Technology Co., Ltd. Oct 11, 2019 |
| K191548 — Nexus Universal Self-Cure | Kerr Corporation Oct 11, 2019 |
| K192235 — AEON Laparoscopic Instruments | Lexington Medical, Inc. Oct 11, 2019 |
| K191902 — Razor, Everest, U&C Liquid | U&C International Co., Ltd. Oct 11, 2019 |
| K191542 — Apyx Plasma/RF Handpiece | Bovie Medical Corporation Dba Apyx Medical Corporation Oct 11, 2019 |
| K190084 — McLean-Ring Enteral Feeding Tube Set | Cook Incorporated Oct 11, 2019 |
| K192515 — BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 | Shenzhen Bioeasy Biotechnology Co., Ltd. Oct 11, 2019 |
| K191208 — Spectra Cashmere | Uzinmedicare Co. Oct 11, 2019 |
| K191420 — Reusable SpO2 Sensor | Shenzhen Changke Connect Electronics Co., Ltd. Oct 11, 2019 |
| K191822 — Nano FortiCore, FortiCore | Nanovis, LLC Oct 11, 2019 |
| K183681 — Protego Antimicrobial Wound Dressing | Global Health Solutions (Dba Turn Therapeutics) Oct 11, 2019 |