| FEMSOFT URETHRAL INSERT (P990002/S002) | Rochester Medical Corp. | 2013-03-21 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT (P860003/S072) | Therakos Development Limited | 2013-03-20 |
| COAPTITE INJECTABLE IMPLANT (P040047/S025) | Merz North America, Inc. | 2013-03-08 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S004) | Torax Medical | 2013-03-07 |
| UROLOGIX TARGIS SYSTEM (P970008/S063) | Urologix, LLC | 2013-03-05 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S030) | Coloplast Corp. | 2013-02-25 |
| H.E.L.P. PLASMAT FUTURA SYSTEM (P940016/S015) | B. Braun Avitum AG | 2013-02-22 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S032) | Coloplast Corp. | 2013-02-21 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S070) | Therakos Development Limited | 2013-02-19 |
| THERAKOS CELLEX / THERAKOS UVAR XTS PHOTOPHERESIS SYSTEMS (P860003/S069) | Therakos Development Limited | 2013-02-15 |
| SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P970004/S148) | Medtronic Neuromodulation | 2013-02-14 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S031) | Coloplast Corp. | 2013-02-14 |
| INTERSTIM NEUROSTIULATOR (P970004/S149) | Medtronic Neuromodulation | 2013-02-14 |
| SNS BOWEL NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P080025/S044) | Medtronic Neuromodulation | 2013-02-14 |
| INTERSTIM NEUROSTIMULATOR (P080025/S045) | Medtronic Neuromodulation | 2013-02-14 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) (P000053/S047) | Boston Scientific Corp | 2013-02-06 |
| AMS ACTICON NEOSPHINCTER-ARTIFICIAL BOWL SPHINCTER (ABS) (P010020/S027) | Boston Scientific Corp | 2013-02-06 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S094) | Boston Scientific Corp | 2013-02-06 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S029) | Coloplast Corp. | 2013-01-29 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S003) | Torax Medical | 2013-01-24 |
| SNS URINARY ACCESSORIES,SNS URINARY EXTENSIONS,SNS URINARY LEADS,SNS URINARY NEUOSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P970004/S147) | Medtronic Neuromodulation | 2013-01-08 |
| SNS BOWEL ACCESSORIES,SNS BOWEL EXTENSIONS,SNS LEADS,SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY,SNS BOWEL (P080025/S043) | Medtronic Neuromodulation | 2013-01-08 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S095) | Boston Scientific Corp | 2013-01-03 |
| MACROPLASTIQUE IMPLANTS, MPQ-2.5 (P040050/S010) | Uroplasty, LLC | 2012-12-28 |
| TARGIS TARGETED TRANSURETHRAL THERMOABLATION SYSTEM (TARGIS SYSTEM): NEW POUCH SEALER (P970008/S062) | Urologix, LLC | 2012-12-20 |
| SOLESTA (P100014/S008) | Palette Life Sciences | 2012-12-19 |
| DEFLUX INJECTABLE GEL (P000029/S073) | Palette Life Sciences | 2012-12-19 |
| SACRAL NERVE STIMULATION- BOWEL IMPLANTABLE NEUROSTIMULATORS (P080025/S035) | Medtronic Neuromodulation | 2012-12-03 |
| SACRAL NERVE STIMULATION - URINARY IMPLANTABLE NEUROSTIMULATORS (P970004/S138) | Medtronic Neuromodulation | 2012-12-03 |
| THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHRESSIS PROCEDURAL KIT (125 ML), CLX, THERAKOS CELLEX LIGHT ASSEMBLY , (P860003/S067) | Therakos Development Limited | 2012-11-19 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S046) | Boston Scientific Corp | 2012-11-13 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S029) | Medtimo, Inc. | 2012-11-09 |
| THERAKOS UVAR XTS INSTRUMENT, THERAKOS UVAR XTS PROCEDURAL KIT (125 ML), THERAKOS UVAR XTS PORCEDURAL KIT (225 ML), THEA (P860003/S066) | Therakos Development Limited | 2012-11-09 |
| INTERSTIM II, 3058 (P970004/S144) | Medtronic Neuromodulation | 2012-11-02 |
| INTERSTIM II 3058 (P080025/S040) | Medtronic Neuromodulation | 2012-11-02 |
| INTERSTIM THERAPY (P970004/S141) | Medtronic Neuromodulation | 2012-11-01 |
| INTERSTIM (P970004/S143) | Medtronic Neuromodulation | 2012-10-24 |
| INTERSTIM (P080025/S039) | Medtronic Neuromodulation | 2012-10-24 |
| COAPTITE INJECTABLE IMPLANT-1.0CC, 8005P10, COAPTITE INJECTABLE IMPLANT-1.0CC, 8005P10P (P040047/S024) | Merz North America, Inc. | 2012-10-18 |
| NEUROSTIMULATOR IMPANTABLE INTERSTIM FAMILY (P970004/S142) | Medtronic Neuromodulation | 2012-10-10 |
| NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P080025/S038) | Medtronic Neuromodulation | 2012-10-10 |
| AMS ACTICON NEOPHINCTER (P010020/S026) | Boston Scientific Corp | 2012-10-05 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S093) | Boston Scientific Corp | 2012-10-05 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S045) | Boston Scientific Corp | 2012-10-05 |
| INTERSTIM (P080025/S037) | Medtronic Neuromodulation | 2012-09-13 |
| INTERSTIM (P970004/S140) | Medtronic Neuromodulation | 2012-09-13 |
| KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM (P050027/S004) | KARL STORZ Endoscopy-America, Inc. | 2012-09-10 |
| ACTICON NEOSPHINCTER (P010020/S024) | Boston Scientific Corp | 2012-09-04 |
| KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM (P050027/S003) | KARL STORZ Endoscopy-America, Inc. | 2012-08-27 |
| INTERSTIM (P970004/S139) | Medtronic Neuromodulation | 2012-08-22 |
| INTERSTIM (P080025/S036) | Medtronic Neuromodulation | 2012-08-22 |
| AMS SPHINCTER 800 URINARY PROSTHESIS (P000053/S041) | Boston Scientific Corp | 2012-08-21 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM (P970004/S137) | Medtronic Neuromodulation | 2012-08-10 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025/S034) | Medtronic Neuromodulation | 2012-08-10 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S092) | Boston Scientific Corp | 2012-08-02 |
| ACTICON NEOSPHINCTER (P010020/S025) | Boston Scientific Corp | 2012-08-02 |
| AMS UROLUME ENDOPROSTHESIS (P920023/S031) | Boston Scientific Corp | 2012-08-02 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S044) | Boston Scientific Corp | 2012-08-02 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S002) | Torax Medical | 2012-06-22 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S001) | Torax Medical | 2012-06-22 |
| LIPOSORBER LA-15 SYSTEM (P910018/S016) | Kaneka Pharma America Corp. | 2012-06-19 |
| INTERSTIM (P970004/S135) | Medtronic Neuromodulation | 2012-06-08 |
| INTERSTIM (P080025/S032) | Medtronic Neuromodulation | 2012-06-08 |
| SNS URINARY INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P970004/S136) | Medtronic Neuromodulation | 2012-06-07 |
| SNS BOWEL INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P080025/S033) | Medtronic Neuromodulation | 2012-06-07 |
| INTERSTIM THERAPY (P080025/S031) | Medtronic Neuromodulation | 2012-06-05 |
| INTERSTIM IMPLANTABLE (P970004/S134) | Medtronic Neuromodulation | 2012-06-05 |
| COAPTITE INJECTABLE IMPLANT (P040047/S021) | Merz North America, Inc. | 2012-05-17 |
| PROLIEVE THERMODILATATION SYSTEM (P030006/S025) | Medifocus, Inc. | 2012-05-17 |
| COAPTITE INJECTABLE IMPLANT (P040047/S019) | Merz North America, Inc. | 2012-05-17 |
| COAPTITE INJECTABLE IMPLANT (P040047/S018) | Merz North America, Inc. | 2012-05-17 |
| SNS URINARY INS INTERSTIM FAMILY (P970004/S133) | Medtronic Neuromodulation | 2012-05-10 |
| SNS BOWEL INS INTERSTIM FAMILY (P080025/S030) | Medtronic Neuromodulation | 2012-05-10 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S043) | Boston Scientific Corp | 2012-05-09 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S083) | Boston Scientific Corp | 2012-05-07 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S031) | Boston Scientific Corp | 2012-05-07 |
| ACTICON NEOSPHINTER (P010020/S017) | Boston Scientific Corp | 2012-05-07 |
| SOLESTA (P100014/S006) | Palette Life Sciences | 2012-05-04 |
| LIPOSORBER LA-15 SYSTEM (P910018/S015) | Kaneka Pharma America Corp. | 2012-05-03 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S090) | Boston Scientific Corp | 2012-05-02 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S042) | Boston Scientific Corp | 2012-05-02 |
| ACTICON NEOSPHINCTER (P010020/S023) | Boston Scientific Corp | 2012-05-02 |
| KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM (P050027/S002) | KARL STORZ Endoscopy-America, Inc. | 2012-05-02 |
| ACTICON NEOSPHINCTER (P010020/S022) | Boston Scientific Corp | 2012-04-26 |
| INTERSTIM II NEUROSTIMULATOR (P970004/S132) | Medtronic Neuromodulation | 2012-04-25 |
| INTERSTIM II NEUROSTIMULATOR (P080025/S029) | Medtronic Neuromodulation | 2012-04-25 |
| SOLESTA (P100014/S005) | Palette Life Sciences | 2012-04-24 |
| INTERSTIM II IMPLANTABLE NEUROSTIMULATOR (P080025/S028) | Medtronic Neuromodulation | 2012-04-20 |
| INTERSTIM II IMPLANTABLE NEUROSTIMULATOR (P970004/S131) | Medtronic Neuromodulation | 2012-04-20 |
| DEFLUX (P000029/S071) | Palette Life Sciences | 2012-04-19 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S028) | Coloplast Corp. | 2012-04-19 |
| INTERSTIM (P080025/S027) | Medtronic Neuromodulation | 2012-04-12 |
| INTERSTIM (P970004/S130) | Medtronic Neuromodulation | 2012-04-12 |
| DEFLUX (P000029/S072) | Palette Life Sciences | 2012-04-12 |
| SOLESTA (P100014/S007) | Palette Life Sciences | 2012-04-12 |
| INTERSTIM THERAPY SYSTEMS (P970004/S124) | Medtronic Neuromodulation | 2012-04-10 |
| INTERSTIM THERAPY SYSTEMS (P080025/S016) | Medtronic Neuromodulation | 2012-04-10 |
| THERAKOS CELLEX / PHOTOPHERESIS SYSTEMS (P860003/S064) | Therakos Development Limited | 2012-04-04 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049) | Torax Medical | 2012-03-22 |
| UROLOGIX TARGIS SYSTEM (P970008/S061) | Urologix, LLC | 2012-03-13 |