| K191734 — MatriStem UBM Pericardial Patch | Acell, Inc. Nov 22, 2019 |
| K191028 — KLS Martin Individual Patient Solutions | KLS-Martin L.P. Nov 22, 2019 |
| K192603 — Spes Medica Subdermal Needle Electrodes | Spes Medica Srl Nov 22, 2019 |
| K192299 — LZI Cotinine II Enzyme Immunoassay | Lin-Zhi International, Inc. Nov 21, 2019 |
| K192996 — Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | Biotronik, Inc. Nov 21, 2019 |
| K192625 — PG Pro Microcatheter | MicroVention, Inc. A TERUMO Group Company Nov 21, 2019 |
| K191464 — Asahi PTCA Guide Wire Asahi SION Series | Asahi Intecc Co., Ltd. Nov 21, 2019 |
| K190439 — Engage Partial Knee System | Engage Uni, LLC Nov 21, 2019 |
| K191488 — SAM IO Intraosseous Access System | Sam® Medical Products, Inc. Nov 21, 2019 |
| K192061 — SOMATOM Go Platform SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO | Siemens Medical Solutions USA, Inc. Nov 21, 2019 |
| K181839 — CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray | Oralabs, Inc. Nov 21, 2019 |
| K192592 — Axis Plating System | Extremity Medical, LLC Nov 21, 2019 |
| K192480 — Torpedo Gelatin Foam | Biosphere Medical, S.A. Nov 21, 2019 |
| K192124 — Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories | Us Medical Innovations, LLC Nov 21, 2019 |
| K192266 — M. Blue Adjustable Shunt System | Aesculap, Inc. Nov 21, 2019 |
| K192672 — uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. Nov 20, 2019 |
| K192792 — TranS1 AxiaLIF Plus System | Trans1 Nov 20, 2019 |
| K192281 — AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System | Medos International SARL Nov 20, 2019 |
| K191865 — SmartLite Pro Modular LED Curing Light | Dentsply Sirona Nov 20, 2019 |
| K181953 — SDS1.2 dental implant | Sds Swiss Dental Solutions AG Nov 20, 2019 |
| DEN180062 — EchoTip Insight Portosystemic Pressure Gradient Measuring System | Cook Ireland, Ltd. Nov 20, 2019 |
| K192664 — FUJIFILM Endoscope Model EC-760Z-V/L | Fujifilm Corporation Nov 20, 2019 |
| K192955 — Penumbra LP Coil System | Penumbra, Inc. Nov 20, 2019 |
| K190497 — Ziehm 8000 | Ziehm Imaging GmbH Nov 20, 2019 |
| K192292 — L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable | Stryker Nov 19, 2019 |
| K192573 — Dolphin Medical Imaging USB Ultrasound System | Dolphin Medical Imaging, LLC Nov 19, 2019 |
| K192269 — TwinScan 808/755 Laser System | Gme German Medical Engineering GmbH Nov 19, 2019 |
| K192643 — Dannik Laparoscopic Suction Irrigation System | Dannik Nov 19, 2019 |
| K191278 — RSI-MRI+ | Multimodal Imaging Services Corporation (Dba Healthlytix) Nov 19, 2019 |
| K190816 — Vial Adapter Ø20 mm , Vial Adapter Ø13 mm | Avenir Performance Europeenne Medical (Apem) Nov 19, 2019 |
| K192204 — Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, | Valencia Naturals, Inc. Nov 19, 2019 |
| K182979 — IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 | Philips Medizin Systeme Boeblingen GmbH Nov 19, 2019 |
| K191980 — CLEARFIL MAJESTY ES Flow | Kuraray Noritake Dental, Inc. Nov 18, 2019 |
| K192769 — Impella CP Introducer | Abiomed, Inc. Nov 18, 2019 |
| K192323 — PolyLock Small Bone Plating System | Fusion Orthopedics, LLC Nov 18, 2019 |
| K183393 — Digital Thermometer | Joytech Healthcare Co. , Ltd. Nov 18, 2019 |
| K190797 — Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) | Reed Medical (Zhejiang) Co., Ltd. Nov 18, 2019 |
| K182732 — JTL-250-01 | Jointechlabs, Inc. Nov 18, 2019 |
| K182917 — FluoroCal | Bisco, Inc. Nov 18, 2019 |
| K192937 — 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company Nov 16, 2019 |
| K190397 — Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | Immunalysis Corporation Nov 15, 2019 |
| K192935 — CAPERE Thrombectomy System | Vascular Medcure, Inc. Nov 15, 2019 |
| K192245 — Pentax Medical Video Duodenoscope ED34-i10T2 | Pentax Of America, Inc. Nov 15, 2019 |
| K191784 — Gabriel Feeding Tube with Balloon, and EnFit Connector | Syncro Medical Innovations, Inc. Nov 15, 2019 |
| K192174 — SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part Of Stryker) Nov 15, 2019 |
| K192936 — Soltus 500 | Sedecal., Sa. Nov 15, 2019 |
| K191701 — Arcus Head Fixation Frame | Mri Interventions, Inc. Nov 15, 2019 |
| K191921 — Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments | Cochlear Americas Nov 15, 2019 |
| K192842 — HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | Eurotrol B.V. Nov 15, 2019 |
| K191247 — SmartSPACE Shoulder System | Techmah Medical, LLC Nov 15, 2019 |