| K183398 — Endoform Restella | Aroa Biosurgery , Ltd. Apr 11, 2019 |
| K183526 — Codman Electrosurgical Generator, Foot Pedal | Kls Martin GmbH + Co. KG Apr 11, 2019 |
| K190317 — Zavation Spinal System | Zavation Medical Products, LLC Apr 11, 2019 |
| K190070 — Sonopet iQ Ultrasonic Aspirator System | Stryker Corporation Apr 11, 2019 |
| K190058 — PureSleep (OTC use) | Sleep Science Partners, Inc. Apr 11, 2019 |
| K181361 — Brux Night Guard | Brux Night Guard Apr 11, 2019 |
| K190786 — Eye Prime | Ellex Medical Pty, Ltd. Apr 11, 2019 |
| K181296 — Syntec Femoral Nail System | Syntec Scientific Corporation Apr 11, 2019 |
| K181758 — ELRA Electrode | Starmed Co., Ltd. Apr 11, 2019 |
| K183306 — GLUCOCARD® W onyx Blood Glucose Monitoring System | Arkray Factory, Inc. Apr 10, 2019 |
| K181110 — PROPHYflex 4 | Kaltenbach & Voigt GmbH Apr 10, 2019 |
| K190631 — M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. Apr 10, 2019 |
| K182662 — NAV PAK Needle, NIM NAV PAK Needle | Boston Endo Surgical Tech, Apr 10, 2019 |
| K182582 — Oryum and Ovem Epidermal Deri Prick Test Applicator | Allergy & Applicator Depot, LLC Apr 10, 2019 |
| K190175 — S-MAK XL | Merit Medical Systems, Inc. Apr 10, 2019 |
| K183057 — PUMA-G System | Coaptech, LLC Apr 10, 2019 |
| K190295 — Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) Apr 10, 2019 |
| K182333 — Vera | Reflexion Health, Inc. Apr 9, 2019 |
| K181832 — Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device | Guangdong Transtek Medical Electronics Co., Ltd. Apr 9, 2019 |
| K190327 — ENConnect 40 mm Screw Cap to ENPlus Adapter | Cedic S.R.L. Apr 9, 2019 |
| K183660 — DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Apr 9, 2019 |
| K182770 — Adult Intraosseous Infusion Device | Einstein Works, LLC Apr 9, 2019 |
| K190653 — ExcelsiusGPS | Globus Medical, Inc. Apr 9, 2019 |
| K182341 — Pantheris SV | Avinger, Inc. Apr 9, 2019 |
| K190611 — VIVIX-S 1751S | Vieworks Co., Ltd. Apr 8, 2019 |
| K182375 — CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® | Globus Medical, Inc. Apr 8, 2019 |
| K183204 — Bone VCAR (BVCAR) | GE Medical Systems SCS Apr 8, 2019 |
| K183606 — Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) | Scandidos AB Apr 8, 2019 |
| K183550 — Vitality® Spinal Fixation System | Zimmer Biomet Spine, Inc. Apr 8, 2019 |
| K190040 — Straumann BLX Line Extension - New Abutments | Institut Straumann AG Apr 8, 2019 |
| K183496 — JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. Apr 8, 2019 |
| K183682 — OIC External Fixation System | Orthopaedic Implant Company Apr 8, 2019 |
| K183539 — Ergoline Sunrise 7200 Hybrid Technology | Jk-Holding GmbH Apr 8, 2019 |
| K182287 — MEDINAUT Plus | Imedicom Co., Ltd. Apr 6, 2019 |
| K190103 — V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System | STERIS Corporation Apr 5, 2019 |
| K183361 — EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. Apr 5, 2019 |
| K190038 — Xbody Newave USA | Xbody Hungary Kft. Apr 5, 2019 |
| K190598 — CROSSWAY Spinal Access System | Globus Medical, Inc. Apr 5, 2019 |
| K182268 — EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) | Flat Medical Co., Ltd. Apr 5, 2019 |
| K183287 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Kossan International Sdn Bhd Apr 5, 2019 |
| K181919 — Patient Monitor | Guangdong Biolight Meditech Co., Ltd. Apr 5, 2019 |
| K190581 — Amplatzer Trevisio Intravascular Delivery System | ABBOTT MEDICAL Apr 5, 2019 |
| K182175 — TCD-X | Atys Apr 5, 2019 |
| K183494 — R190/R191 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. Apr 5, 2019 |
| K173770 — OJR215 Pressure Relief Manifold | Fisher & Paykel Healthcare Limited Apr 5, 2019 |
| K190416 — Dome Electrode | Coapt, LLC Apr 4, 2019 |
| K173238 — ToxCO | Bedfont Scientific, Ltd. Apr 4, 2019 |
| K190164 — CleverLock Guidewire Locking Device and Biopsy Cap | Olympus Surgical Technologies America Apr 4, 2019 |
| K190691 — Pixx2430 Digital Diagnostic X-Ray Receptor Panel | Pixxgen Corporation Apr 4, 2019 |
| K183377 — DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Apr 4, 2019 |