| K180139 — Safe Secure Sterilization Pouches and Rolls | Safe Secure Packing Co., Ltd. Jan 3, 2019 |
| K182568 — V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | STERIS Corporation Jan 3, 2019 |
| K181127 — EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control | Interscope, Inc. Jan 3, 2019 |
| K183300 — VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack | Steris Corporations Jan 3, 2019 |
| K183294 — CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack | STERIS Corporation Jan 3, 2019 |
| K183643 — Clear Image Aligners | Specialty Appliance Works, Inc. Jan 3, 2019 |
| K183214 — Raven Lumbar Plate System | Choicespine, LP Jan 3, 2019 |
| K183143 — uCT 520, uCT 528 | Shangai United Imaging Healthcare Co., Ltd. Jan 3, 2019 |
| K180984 — Maxcon Sharps Container | Ningbo Maxcon Medical Technology Co., Ltd. Jan 3, 2019 |
| K182855 — ProKnow DS | Proknow, LLC Jan 2, 2019 |
| K182025 — ClearUP Sinus Pain Relief | Tivic Health Systems, Inc. Jan 2, 2019 |
| K183476 — 3M Filtek Universal Restorative | 3M Espe Dental Products Jan 2, 2019 |
| K181864 — Polaris RF Ablation System | Baylis Medical Company, Inc. Jan 2, 2019 |
| K181215 — Infrared Thermometer | Shenzhen Finicare Co., Ltd. Jan 2, 2019 |
| K183542 — Signature Orthodontic System | Signature Orthodontics Jan 2, 2019 |
| K181737 — Raycell MK1 | Best Theratronics Limited Jan 2, 2019 |
| K183352 — Optimus Neuro System | Osteonic Co., Ltd. Jan 2, 2019 |
| K182199 — NFC-700 non-mydriatic auto fundus camera | Crystalvue Medical Corporation Jan 2, 2019 |