| MAESTRO RECHARGEABLE SYSTEM (P130019/S009) | Reshape Lifesciences, Inc. | 2016-06-27 |
| COAPTITE Injectable Implant (P040047/S043) | Merz North America, Inc. | 2016-06-27 |
| AspireAssist (P150024) | Aspire Bariatrics, Inc. | 2016-06-14 |
| INTERSTIM THERAPY SYSTEM (Urinary) (P970004/S213) | Medtronic Neuromodulation | 2016-06-07 |
| INTERSTIM THERAPY SYSTEM (Bowel) (P080025/S108) | Medtronic Neuromodulation | 2016-06-07 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S008) | Reshape Lifesciences, Inc. | 2016-06-03 |
| AMS 700 INFLATABLE PENILE PROSTHESES (IPP) (N970012/S115) | Boston Scientific Corp | 2016-05-31 |
| AMS 800 URINARY CONTROL SYSTEM (AUS) (P000053/S063) | Boston Scientific Corp | 2016-05-31 |
| ORBERA INTRAGASTRIC BALLOON SYSTEM (P140008/S003) | Boston Scientific Corporation | 2016-05-23 |
| LAP-BAND ADJUSTABLE GASTIC BANDING SYSTEM (P000008/S035) | Medtimo, Inc. | 2016-05-23 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S017) | Torax Medical | 2016-05-19 |
| Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier; Ethicon Endo-Surgery Gastric Band (P070009/S016) | Obtech Medical GmbH | 2016-05-16 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S212) | Medtronic Neuromodulation | 2016-05-05 |
| THERAKOS UVAR XTS Photopheresis System Procedural Kit (P860003/S086) | Therakos Development Limited | 2016-05-05 |
| INTERSTIM THERAPY SYSTEM (P080025/S107) | Medtronic Neuromodulation | 2016-05-05 |
| UVAR PHOTOPHERESIS SYSTEM (P860003/S085) | Therakos Development Limited | 2016-04-22 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S210) | Medtronic Neuromodulation | 2016-04-21 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025/S105) | Medtronic Neuromodulation | 2016-04-21 |
| LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). (P910018/S019) | Kaneka Pharma America Corp. | 2016-04-19 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT (P860003/S083) | Therakos Development Limited | 2016-04-08 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S016) | Carbon Medical Technologies, Inc. | 2016-04-06 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025/S106) | Medtronic Neuromodulation | 2016-03-31 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S211) | Medtronic Neuromodulation | 2016-03-31 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S037) | Medtimo, Inc. | 2016-03-28 |
| H.E.L.P. PLASMAT FUTURA SYSTEM (P940016/S020) | B. Braun Avitum AG | 2016-03-17 |
| LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). (P910018/S018) | Kaneka Pharma America Corp. | 2016-03-10 |
| PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR (P820033/S010) | Asahi Kasei Medical Co., Ltd. | 2016-03-09 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S034) | Medtimo, Inc. | 2016-03-03 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S015) | Torax Medical | 2016-03-02 |
| ORBERA INTRAGASTRIC BALLOON SYSTEM (P140008/S001) | Boston Scientific Corporation | 2016-03-02 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S016) | Torax Medical | 2016-03-02 |
| ORBERA INTRAGASTRIC BALLOON SYSTEM (P140008/S002) | Boston Scientific Corporation | 2016-02-26 |
| THERAKOS CELLEX PROCEDURAL KIT (P860003/S084) | Therakos Development Limited | 2016-02-25 |
| DEFLUX INJECTABLE GEL (P000029/S080) | Palette Life Sciences | 2016-02-23 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S007) | Reshape Lifesciences, Inc. | 2016-02-12 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S036) | Medtimo, Inc. | 2016-02-08 |
| AMS 800 URINARY CONTROL SYSTEM (AUS) (P000053/S056) | Boston Scientific Corp | 2016-02-04 |
| AMS ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (ABS) (P010020/S029) | Boston Scientific Corp | 2016-02-04 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S105) | Boston Scientific Corp | 2016-02-04 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S111) | Boston Scientific Corp | 2016-02-03 |
| INTERSTIM THERAPY SYSTEM (P080025/S104) | Medtronic Neuromodulation | 2016-01-25 |
| INTERSTIM THERAPY SYSTEM (P970004/S209) | Medtronic Neuromodulation | 2016-01-25 |
| RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT (P140012/S003) | Boston Scientific Corporation | 2016-01-22 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT (P860003/S082) | Therakos Development Limited | 2016-01-21 |
| RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S001) | Boston Scientific Corporation | 2016-01-14 |
| RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT (P140012/S004) | Boston Scientific Corporation | 2015-12-31 |
| INTERSTIM THERAPY SYSTEM (P080025/S103) | Medtronic Neuromodulation | 2015-12-23 |
| INTERSTIM THERAPY SYSTEM (P970004/S208) | Medtronic Neuromodulation | 2015-12-23 |
| INTERSTIM THERAPY SYSTEM (P970004/S204) | Medtronic Neuromodulation | 2015-12-21 |
| INTERSTIM THERAPY SYSTEM (P080025/S099) | Medtronic Neuromodulation | 2015-12-21 |
| RESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BALLOON ASSEMBLY,RESHAPE REMOVAL CATHETER,RESHAPE VALVE SEALANT (P140012/S002) | Boston Scientific Corporation | 2015-12-21 |
| PLASMAFLO (P820033/S009) | Asahi Kasei Medical Co., Ltd. | 2015-12-03 |
| PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN (P130018) | Uromedica, Inc. | 2015-11-24 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S045) | Coloplast Corp. | 2015-11-23 |
| INTERSTIM THERAPY SYSTEM (P080025/S102) | Medtronic Neuromodulation | 2015-11-20 |
| INTERSTIM THERAPY SYSTEM (P970004/S207) | Medtronic Neuromodulation | 2015-11-20 |
| COAPTITE (P040047/S040) | Merz North America, Inc. | 2015-11-12 |
| GAMBRO PRISMAFLEX TPE 2000 SET (P830063/S008) | Vantive US Healthcare, LLC | 2015-11-12 |
| INTERSTIM THERAPY SYSTEM (P970004/S206) | Medtronic Neuromodulation | 2015-11-10 |
| INTERSIM THERAPY SYSTEM (P080025/S101) | Medtronic Neuromodulation | 2015-11-10 |
| THERAKOS CELLEX PHOTOSPHERESIS SYSTEM INSTRUMENT (P860003/S081) | Therakos Development Limited | 2015-11-02 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S112) | Boston Scientific Corp | 2015-10-30 |
| INTERSTIM THERAPY SYSTEM (P080025/S100) | Medtronic Neuromodulation | 2015-10-30 |
| INTERSTIM THERAPY SYSTEM (P970004/S205) | Medtronic Neuromodulation | 2015-10-30 |
| UROLOGIX TARGIS SYSTEM (P970008/S065) | Urologix, LLC | 2015-10-29 |
| COAPTITE INJECTABLE IMPLANT (P040047/S038) | Merz North America, Inc. | 2015-10-28 |
| AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS (N970012/S113) | Boston Scientific Corp | 2015-10-14 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S061) | Boston Scientific Corp | 2015-10-14 |
| COAPTITE (P040047/S042) | Merz North America, Inc. | 2015-10-01 |
| INTERSTIM THERAPY SYSTEM FOR BOWEL CONTROL (P080025/S098) | Medtronic Neuromodulation | 2015-09-09 |
| INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S203) | Medtronic Neuromodulation | 2015-09-09 |
| UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S064) | Urologix, LLC | 2015-08-28 |
| H.E.L.P. PLASMAT FUTURA SYSTEM (P940016/S016) | B. Braun Avitum AG | 2015-08-11 |
| ORBERA INTRAGASTRIC BALLOON (P140008) | Boston Scientific Corporation | 2015-08-05 |
| AMS 700, AMS AMBICOR, AMS 700 WITH MS PUMP INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S110) | Boston Scientific Corp | 2015-08-04 |
| THERAKOS CELLEX PROCEDURAL KIT (P860003/S080) | Therakos Development Limited | 2015-07-30 |
| RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012) | Boston Scientific Corporation | 2015-07-28 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S014) | Torax Medical | 2015-07-24 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S002) | Reshape Lifesciences, Inc. | 2015-07-24 |
| COAPTITE (P040047/S041) | Merz North America, Inc. | 2015-07-23 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S013) | Torax Medical | 2015-07-20 |
| INTERSTIM THERAPY SYSTEM (P970004/S202) | Medtronic Neuromodulation | 2015-07-16 |
| SNS URINARY NEUROSTIMULATORS IMPLANTABLE INTERSTIM (P970004/S201) | Medtronic Neuromodulation | 2015-07-16 |
| INTERSTIM THERAPY SYSTEM (P080025/S096) | Medtronic Neuromodulation | 2015-07-16 |
| INTERSTIM THERAPY SYSTEM (P080025/S097) | Medtronic Neuromodulation | 2015-07-16 |
| LIPOSORBER LA-15 SYSTEM (P910018/S017) | Kaneka Pharma America Corp. | 2015-07-15 |
| INTERSTIM THERAPY SYSTEM (P970004/S200) | Medtronic Neuromodulation | 2015-07-10 |
| INTERSTIM THERAPY SYSTEM (P080025/S095) | Medtronic Neuromodulation | 2015-07-10 |
| INTERSTIM THERAPY SYSTEM (P970004/S199) | Medtronic Neuromodulation | 2015-07-01 |
| INTERSTIM THERAPY SYSTEM (P080025/S094) | Medtronic Neuromodulation | 2015-07-01 |
| VERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR URINARY CONTROL AND BOWEL CONTROL (P080025/S083) | Medtronic Neuromodulation | 2015-06-26 |
| GAMBRO PRISMAFLEX TPE 2000 SET (P830063/S007) | Vantive US Healthcare, LLC | 2015-06-26 |
| VERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR URINARY CONTROL AND BOWEL CONTROL (P970004/S187) | Medtronic Neuromodulation | 2015-06-26 |
| AMS 700/AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S109) | Boston Scientific Corp | 2015-06-24 |
| ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S033) | Boston Scientific Corp | 2015-06-24 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S060) | Boston Scientific Corp | 2015-06-24 |
| HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM (P940016/S019) | B. Braun Avitum AG | 2015-06-18 |
| HEPARIN-INDUCED EXTRACORPOREAL LDL-PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM (P940016/S018) | B. Braun Avitum AG | 2015-06-16 |
| HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.)FUTURA APHERESIS SYSTEM (P940016/S017) | B. Braun Avitum AG | 2015-06-15 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S001) | Reshape Lifesciences, Inc. | 2015-06-02 |