| K182904 — syngo.MR Applications | Siemens Medical Solutions USA, Inc. Jul 5, 2019 |
| K190174 — Miethke Shunt System GAV 2.0 and SA 2.0 Valves | Aesculap, Inc. Jul 5, 2019 |
| K190498 — Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. Jul 5, 2019 |
| K183149 — Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim | Central Medicare Sdn Bhd Jul 4, 2019 |
| K190950 — Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) | Medline Industries, Inc. Jul 4, 2019 |
| K190589 — Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments | Cochlear Americas Jul 3, 2019 |
| K190915 — OsteoFab Suture Anchors | Oxford Performance Materials, Inc. Jul 3, 2019 |
| K191204 — Infinity Fixation System | Conmed Corporation Jul 3, 2019 |
| K190959 — ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | Medtronic Sofamor Danek USA, Inc. Jul 3, 2019 |
| K191169 — NuVasive® Camber Laminoplasty System | Nu Vasive, Incorporated Jul 3, 2019 |
| K190442 — Koios DS for Breast | Koios Medical, Inc. Jul 3, 2019 |
| K182780 — XP Composite | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH Jul 3, 2019 |
| K183058 — Arm-type Electronic Blood Pressure Monitor | Shenzhen Bsx Technology Electronics Co., Ltd. Jul 3, 2019 |
| K190272 — Bluephase PowerCure | Ivoclar Vivadent, AG Jul 3, 2019 |
| K190724 — MD-Temp Plus | Meta Biomed Co., Ltd. Jul 3, 2019 |
| K191018 — Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors | Surgical Instrument Service And Savings, Inc. Jul 3, 2019 |
| K182580 — Novidia Flowable Composite | Nobio , Ltd. Jul 3, 2019 |
| K191495 — Biopsy Positioner | Fujifilm Corporation Jul 3, 2019 |
| K180968 — AlphaDent Implants Dental Implants System | Alphadent Implants, Ltd. Jul 3, 2019 |
| K191468 — syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. Jul 3, 2019 |
| K191451 — CMDR 2CW (Multiple models) | Minxray, Inc. Jul 3, 2019 |
| K191460 — PWD Platform Wound Dressing 3 x 5 Oblong | Applied Tissue Technologies, LLC Jul 2, 2019 |
| K191137 — 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 | Jvckenwood Corporation Jul 2, 2019 |
| K191008 — iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation Jul 2, 2019 |
| K183138 — Certain BellaTek Express and BellaTek Flex Abutments | Biomet 3I Jul 2, 2019 |
| K190687 — Twilite Appliance | Stephen J Harkins, Dds, PC Jul 2, 2019 |
| K190617 — Wrap accessory electrodes | Hi-Dow International, Inc. Jul 2, 2019 |
| K190351 — Site Seal SV | Ensite Vascular Jul 2, 2019 |
| K182876 — Uro-N Cystoscope | Uroviu Corporation Jul 2, 2019 |
| K190634 — Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. Jul 2, 2019 |
| K190524 — MRopen 0.5 T | Asg Superconductors S.P.A. Jul 1, 2019 |
| K183062 — ASAHI Silverway | Asahi Intecc Co., Ltd. Jul 1, 2019 |
| K190905 — BD Phoenix Automated Microbiology System GN Ceftaroline (0.0156-4 µg/mL) | Becton, Dickinson And Company Jul 1, 2019 |
| K190166 — TriMed Nitinol Staple System | TriMed, Inc. Jul 1, 2019 |
| K190550 — IKON 40 Manual Wheelchair | Broda Seating (Broda Lp) Jul 1, 2019 |
| K183173 — LIGHTMED Ultrasound System | Lightmed USA, Inc. Jul 1, 2019 |
| K190980 — Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health, LLC Jul 1, 2019 |
| K182847 — Hudson RCI Voldyne Volumetric Exerciser | Teleflexmedical, Inc. Jul 1, 2019 |
| K191223 — NAVIO | Blue Belt Technologies, Inc. Jun 28, 2019 |
| K191483 — HEALIX ADVANCE Anchor with DYNA+TAPE Sutures | Medos International SARL Jun 28, 2019 |
| K191450 — Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System | Dexcom, Inc. Jun 28, 2019 |
| K190654 — Straumann CI RD Ceramic Healing Caps | Institut Straumann AG Jun 28, 2019 |
| K190582 — MicroLink All-Suture Button Fixation System (Radiopaque) | Conmed Corporation Jun 28, 2019 |
| K190101 — UltraFlex IAB | Arrow International, Inc. Jun 28, 2019 |
| K190475 — Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 | Centerpoint Systems Jun 28, 2019 |
| K190341 — iC-GN iC-Cassette for use on the iC-System | Icubate, Inc. Jun 28, 2019 |
| K183021 — ClearEndoclip | Finemedix Co., Ltd. Jun 28, 2019 |
| K190251 — RecoveryRx | Bioelectronics Corporation Jun 28, 2019 |
| K181672 — SureTouch Mobile Pressure Mapping System | Sure, Inc. Jun 28, 2019 |
| K183064 — TxTi IBF System | Innovasis, Inc. Jun 28, 2019 |