| K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin | HORIBA ABX SAS Aug 30, 2019 |
| K190205 — HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC Aug 29, 2019 |
| K190613 — BD MAX Check-Points CPO | Check-Points Health B.V. Aug 29, 2019 |
| K183489 — D2P | 3D Systems, Inc. Aug 29, 2019 |
| K182219 — SGS Dental Implants System | Sgs International, Ltd. Aug 29, 2019 |
| K182382 — Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink | Gmp Medicare Sdn Bhd (F25) Aug 29, 2019 |
| K182811 — gel-e Flex+ | Gel-E, Inc. Aug 29, 2019 |
| K192076 — Binary® Anterior Cervical Plate System | Genesys Spine Aug 29, 2019 |
| K191281 — Omni Hysteroscope, Omni Lok cervical seal | Hologic, Inc. Aug 29, 2019 |
| K192159 — Voluson E6, Voluson E8, Voluson E10 | GE Healthcare Aug 29, 2019 |
| K190744 — ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Olympus Winter & Ibe GmbH Aug 29, 2019 |
| K191439 — OverStitch 2-0 Polypropylene Suture | Apollo Endosurgery Aug 29, 2019 |
| K190236 — O2Vent Optima | Oventus Manufacturing Pty, Ltd. Aug 29, 2019 |
| K191159 — Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity | Invacare Corporation Aug 29, 2019 |
| K192035 — EvaQMax Smoke Evacuation System | Bio Protech, Inc. Aug 29, 2019 |
| K192054 — Endoskeleton TAS Plate | Titan Spine, Inc. Aug 29, 2019 |
| K191319 — Dunamis Fixation Button System | Dunamis, LLC Aug 29, 2019 |
| K192107 — Clarius Ultrasound Scanner | Clarius Mobile Health Corp. Aug 29, 2019 |
| K183605 — Spine & Trauma Navigation | Brainlab AG Aug 29, 2019 |
| K191939 — Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. Aug 29, 2019 |
| K192042 — Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal | Geistlich Pharma AG Aug 29, 2019 |
| K191475 — Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate | Nobel Biocare AB Aug 29, 2019 |
| K192036 — ClotTriever Thrombectomy System | Inari Medical Aug 29, 2019 |
| K182142 — FEMME Applicator Tampon | Jiangsu Yoai Technology Co., Ltd. Aug 28, 2019 |
| K191569 — Implantcast ic-Bipolar Head System | Implantcast GmbH Aug 28, 2019 |
| K191399 — BIOLOX CONTOURA Ceramic Femoral Head | Total Joint Othopedics, Inc. Aug 28, 2019 |
| K191533 — ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Siemens Healthcare Diagnostics, Inc. Aug 28, 2019 |
| K191778 — Omnia Medical VBR | Omnia Medical, LLC Aug 28, 2019 |
| K190269 — PureLift | Xtreem Pulse, LLC Aug 28, 2019 |
| K182401 — B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter | Amzetta Technologies Private Limited Aug 28, 2019 |
| K191424 — Interphalangeal Joint Fusion Device Range | Neosteo Aug 28, 2019 |
| K191414 — EXETER Centralizer, EXETER 2.5mm Plug | Stryker Orthopaedics Aug 28, 2019 |
| K190704 — Signature Ceramic Femoral Head | Signature Orthopaedics Pty, Ltd. Aug 28, 2019 |
| K191810 — Curiteva Pedicle Screw System | Curiteva, Inc. Aug 28, 2019 |
| K191780 — AP50/30 Insufflator with Insuflow Port | Lexion Medical, LLC Aug 28, 2019 |
| K190904 — Conformis BeneFIT Hip System | Conformis, Inc. Aug 28, 2019 |
| K190437 — Delta 3300 | Netech Corporation Aug 28, 2019 |
| K183485 — CryoVizion System | Cryos Technologies, Inc. Aug 28, 2019 |
| K191107 — Plexus | Alleva Medical (D.G), Ltd. Aug 27, 2019 |
| K191077 — Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor | Medtronic, Inc. Aug 27, 2019 |
| K191427 — Halley resin system | Dentsply Sirona Aug 26, 2019 |
| K192043 — AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation Aug 26, 2019 |
| K191382 — IPS e.max CAD Abutment Solutions- extra systems | Ivoclar Vivadent, AG Aug 26, 2019 |
| K191039 — Navigated T2 STRATOSPHERE Inserters and Navigated Templates | Medtronic Sofamor Danek USA, Inc. Aug 26, 2019 |
| K183122 — 810nm Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd Aug 25, 2019 |
| K191981 — REMEDY Acetabular Cup | Osteoremedies, LLC Aug 23, 2019 |
| K190813 — CrossBay Cervical Dilator Catheter System | Crossbay Medical Aug 23, 2019 |
| K183544 — Efficient Care 3D Planning | Orthosoft Inc (D/B/A Zimmer Cas) Aug 23, 2019 |
| K191177 — LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head | Smith And Nephew, Inc. Aug 23, 2019 |
| K183315 — CustMBite Dental Guard | Dental Choice Holdings, LLC Aug 23, 2019 |