| CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack (K183294) | STERIS Corporation | 2019-01-03 |
| EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control (K181127) | Interscope, Inc. | 2019-01-03 |
| Vis-U-All Low Temperature Sterilization Pouch/Tubing (K183297) | STERIS Corporation | 2019-01-03 |
| uCT 520, uCT 528 (K183143) | Shangai United Imaging Healthcare Co., Ltd. | 2019-01-03 |
| VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack (K183300) | Steris Corporations | 2019-01-03 |
| Raven Lumbar Plate System (K183214) | Choicespine, LP | 2019-01-03 |
| Maxcon Sharps Container (K180984) | Ningbo Maxcon Medical Technology Co., Ltd. | 2019-01-03 |
| Clear Image Aligners (K183643) | Specialty Appliance Works, Inc. | 2019-01-03 |
| Maxcon Two Gallon Chemotherapy Container (K180983) | Ningbo Maxcon Medical Technology Co., Ltd. | 2019-01-03 |
| ProKnow DS (K182855) | Proknow, LLC | 2019-01-02 |
| Optimus Neuro System (K183352) | Osteonic Co., Ltd. | 2019-01-02 |
| NFC-700 non-mydriatic auto fundus camera (K182199) | Crystalvue Medical Corporation | 2019-01-02 |
| Infrared Thermometer (K181215) | Shenzhen Finicare Co., Ltd. | 2019-01-02 |
| ClearUP Sinus Pain Relief (K182025) | Tivic Health Systems, Inc. | 2019-01-02 |
| Raycell MK1 (K181737) | Best Theratronics Limited | 2019-01-02 |
| Polaris RF Ablation System (K181864) | Baylis Medical Company, Inc. | 2019-01-02 |
| 3M Filtek Universal Restorative (K183476) | 3M Espe Dental Products | 2019-01-02 |
| Signature Orthodontic System (K183542) | Signature Orthodontics | 2019-01-02 |