| RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S006) | Boston Scientific Corporation | 2017-01-06 |
| Evera MRI, S DR, S VR, XT DR, XTVR ICD's; Maximo II ICD; Protecta VR, XT ICDs; Secura DR ICD's; Virtuose II DR/VR ICD; V (P980016/S606) | Medtronic Cardiac Rhythm Disease Management | 2017-01-06 |
| 13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT) (P110015/S002) | Advanced Breath Diagnostics | 2017-01-06 |
| RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S007) | Boston Scientific Corporation | 2017-01-06 |
| BUZZER COMPONENT (P110042/S072) | Boston Scientific Corporation | 2017-01-06 |
| Amplia MRI/MRI Quad CRT-D's; Brava CRT-D; Compia MRI/MRI Quad CRT-Ds; Concerto II CRT-D; Consulta CRT-D; Maximo II CRT-D (P010031/S567) | Medtronic Cardiac Rhythm Disease Management | 2017-01-06 |
| MODEL 4323 PRESSURE SENSING LEAD ADAPTER COMPONENT (P130008/S019) | Inspire Medical Systems | 2017-01-06 |
| ELCA (P910001/S090) | Spectranetics Corp. | 2017-01-05 |
| PLEXA S 60, PLEXA SD 60/16, PLEXA PROMRI S 65, PLEXA PROMRI S 75, PLEXA PROMRI SD 65/16, PLEXA PROMRI SD 65/18, PLEXA PR (P980023/S075) | Biotronik, Inc. | 2017-01-05 |
| SENOCLAIRE (P130020/S001) | GE Healthcare | 2017-01-05 |
| SLS II/GLIDELIGHT CATHETERS (P960042/S055) | Spectranetics (Philips) | 2017-01-05 |
| Misago RX Self-expanding Peripheral Stent (P140002/S006) | Terumo Medical Corporation | 2017-01-05 |
| ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM (P040012/S057) | Abbott Vascular | 2017-01-05 |
| BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 (P100025/S011) | Meridian Bioscience, Inc. | 2017-01-04 |
| FLOSEAL MATRIX HEMOSTATIC SEALANT (P990009/S045) | Baxter Healthcare Corp | 2017-01-04 |
| BELOTERO BALANCE DERMAL FILLER (P090016/S022) | Merz North America, Inc. | 2017-01-04 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S044) | DePuy Orthopaedics, Inc. | 2017-01-03 |