| FLEXTOME CORONARY CUTTING BALLOON (P950020/S061) | Boston Scientific Corp | 2013-06-21 |
| ZIMMER NEXT GEN LPS -FLEX MOBILE AND LPS-MOBILE BEARING KNEE (P060037/S022) | Zimmer, Inc. | 2013-06-21 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, INCEEPTA, ENERGEN, PUNCTUA, TELIGEN , ICD'S (P960040/S295) | Boston Scientific | 2013-06-21 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S046) | Boston Scientific Corp | 2013-06-21 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS, INC EPTA, ENERGEN, PUNCTUA, C OGNIS CRT-D'S (P010012/S330) | Boston Scientific Corp | 2013-06-21 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S051) | Boston Scientific Corp | 2013-06-21 |
| CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S006) | Microport Orthopedics, Inc. | 2013-06-20 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S167) | Boston Scientific Corp | 2013-06-20 |
| GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S038) | Gynecare, Inc. | 2013-06-20 |
| LATITUDE COMMUNICATOR (P910077/S135) | Boston Scientific | 2013-06-20 |
| ARCTIC FRONT AND ARTIC FRONT ADVANCE (P100010/S024) | Medtronic Cryocath, LP | 2013-06-20 |
| COLLACOTE, COLLATAPE, AND COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S029) | Integra Lifesciences Corp. | 2013-06-20 |
| REPLY/ESPRIT SR AND DR MODEL PACEMAKERS (P950029/S079) | MicroPort CRM USA, Inc. | 2013-06-20 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S021) | Allergan | 2013-06-20 |
| GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S009) | Glaukos Corporation | 2013-06-20 |
| NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS (P040046/S003) | Allergan | 2013-06-20 |
| HELISTAT AND HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S039) | Integra LifeSciences Corporation | 2013-06-20 |
| ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) (P120012) | Abbott Molecular | 2013-06-20 |
| ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S134) | Boston Scientific | 2013-06-20 |
| COLLASTAT/INSTAT MCH ABSORBABLE COLLAGEN HEMOSTATIC AGENT-FIBRILLAR FORM (P810006/S042) | Integra LifeSciences Corporation | 2013-06-20 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S040) | Integra LifeSciences Corporation | 2013-06-20 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S036) | Baxter Healthcare Corp | 2013-06-19 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S166) | Boston Scientific Corp | 2013-06-19 |
| CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD (P850089/S099) | Medtronic Cardiac Rhythm Disease Management | 2013-06-19 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S122) | Boston Scientific Corp | 2013-06-19 |
| ACTIVA PC NEUROSTIMULATOR, ACTIVA SC NEUROSTIMULATOR, ACTIVA RC NEUROSTIMULATOR AND EXTERNAL NEUROSTIMULATOR (P960009/S165) | Medtronic, Inc. | 2013-06-19 |
| M-VU ALGORITHM ENGINE (P100005/S002) | Icad, Inc. | 2013-06-19 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S040) | Integra LifeSciences Corporation | 2013-06-19 |
| SECONDLOOK DIGITAL (P010038/S017) | Icad, Inc. | 2013-06-19 |
| EVERA S DR ICD,EVERA S VR, ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S419) | Medtronic Cardiac Rhythm Disease Management | 2013-06-19 |
| ADAPTA, VERSA, SENSIA, RELIA IPG (P980035/S329) | Medtronic, Inc. | 2013-06-19 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P810006/S041) | Integra LifeSciences Corporation | 2013-06-19 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S379) | Medtronic Cardiac Rhythm Disease Management | 2013-06-19 |
| RESTORE ULTRA NEUROSTIMULATOR, RESTORE SENSOR NEUROSTIMULATOR, ITREL 4 NEUROSTIMULATOR AND ENTERNAL NEUROSTIMULATOR (P840001/S234) | Medtronic Neuromodulation | 2013-06-19 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S165) | Boston Scientific Corp | 2013-06-19 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S204) | Medtronic, Inc. | 2013-06-19 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEAD (P930039/S090) | Medtronic, Inc. | 2013-06-19 |
| LEAD ANCHORING SLEEVE KIT (P030036/S059) | Medtronic Cardiac Rhythm Disease Management | 2013-06-19 |
| ATTAIN ABILITY LEAD (P080006/S055) | Medtronic, Inc. | 2013-06-19 |
| CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCLLENCE PS+ LEAD (P830061/S094) | Medtronic Cardiac Rhythm Disease Management | 2013-06-19 |
| TECNIS ACRYLIC IOL (P990080/S038) | Johnson & Johnson Surgical Vision, Inc. | 2013-06-18 |
| N VISION PROGRAMMER (P860004/S187) | Medtronic, Inc. | 2013-06-18 |
| ARISTA AH ABSORBABLE HEMOSTAT (P050038/S018) | Davol, Inc. | 2013-06-18 |
| HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS, HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENT FIBULLAR FORM (P850010/S036) | Integra LifeSciences Corporation | 2013-06-18 |
| TECNIS MULTIFOCAL 3-PIECE IOL (P080010/S009) | Johnson & Johnson Surgical Vision, Inc. | 2013-06-18 |
| HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S038) | Integra LifeSciences Corporation | 2013-06-18 |
| HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S037) | Integra LifeSciences Corporation | 2013-06-18 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT (P810006/S039) | Integra LifeSciences Corporation | 2013-06-18 |
| AORFIX AA FLEXIBLE STENT GRAFT SYSTEM (P110032/S003) | Lombard Medical Limited | 2013-06-18 |
| COLLACOTE COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY (P840062/S028) | Integra Lifesciences Corp. | 2013-06-18 |
| ADAPTA,VERSA,SENSIA IPG,RELIA IPG (P980035/S320) | Medtronic, Inc. | 2013-06-18 |
| REZOOM MULTIFOCAL IOL (P960028/S037) | Johnson & Johnson Surgical Vision, Inc. | 2013-06-18 |
| WALLSTENT RP ENDOPROSTHESIS (ILIAC) (P940019/S035) | Boston Scientific Scimed, Inc. | 2013-06-18 |
| WALLSTENT RP ENDOPROSTHESIS AND WALLSTENT ENDOPROSTHESIS (VENOUS) (P980033/S029) | Boston Scientific Corporation | 2013-06-18 |
| WALLSTENT RP ENDOPROSTHESIS AND WALLSTENT ENDOPROTHESIS (TIPS) (P930031/S040) | Boston Scientific Corp | 2013-06-18 |
| SENSAR ACRYLIC IOL, TECNIS 1-PIECE IOL, TECNIS OPTIBLUE 1-PIECE IOL, TECNIS MULTIFOCAL 1-PIECE IOL (P980040/S045) | Johnson & Johnson Surgical Vision, Inc. | 2013-06-18 |
| INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S151) | Medtronic Neuromodulation | 2013-06-17 |
| ACTIVA DEPP BRAIN STIMULATION ACTIVA PC, ACTIVA SC, ACTIVA RC, KINETRA (P960009/S166) | Medtronic, Inc. | 2013-06-17 |
| SPINAL CORD STIMULATION (ITREL SYNERGY, SYNERGY VERSITREL, RESTOREPRIME, RESTORE ADVANCED, PRIME ADVANCED RESTOR ULTRA, (P840001/S235) | Medtronic Neuromodulation | 2013-06-17 |
| AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM (P110032/S002) | Lombard Medical Limited | 2013-06-17 |
| SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM (P110006/S001) | GE Healthcare | 2013-06-17 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S041) | Endologix, LLC | 2013-06-17 |
| INTERSTIM THERAPY FOR BOWEL CONTROL (P080025/S047) | Medtronic Neuromodulation | 2013-06-17 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S053) | W. L. Gore & Associates, Inc. | 2013-06-17 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S203) | Medtronic, Inc. | 2013-06-14 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S328) | Medtronic, Inc. | 2013-06-14 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, VIVA S CRT-D (P010031/S378) | Medtronic Cardiac Rhythm Disease Management | 2013-06-14 |
| SPECTRANETICS LASER SHEATH (P960042/S043) | Spectranetics (Philips) | 2013-06-14 |
| ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB (P100046/S002) | AtriCure, Inc. | 2013-06-14 |
| MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028) | Mentor Worldwide, LLC | 2013-06-14 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S052) | W. L. Gore & Associates, Inc. | 2013-06-14 |
| REVO MRT IPG (P090013/S100) | Medtronic, Inc. | 2013-06-14 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S418) | Medtronic Cardiac Rhythm Disease Management | 2013-06-14 |
| ARTIC FRONT CRYOABLATION CATHETER,ARTIC FRONT ADAVNCE CRYOABLATION CATHETER (P100010/S028) | Medtronic Cryocath, LP | 2013-06-12 |
| FORTIFY AND PROMOTE QUANDRA FAMILY OF ICDS (P910023/S316) | ABBOTT MEDICAL | 2013-06-12 |
| NOVA TTF-100A SYSTEM (P100034/S005) | Novocure, GmbH | 2013-06-12 |
| ARCHITECT AFP,LN 3P36 (P120008/S003) | Abbott Laboratories | 2013-06-12 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S020) | Allergan | 2013-06-12 |
| NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS (P040046/S002) | Allergan | 2013-06-12 |
| T-SPOT .TB TEST (P070006/S009) | Oxford Immunotec, Ltd. | 2013-06-12 |
| UNIFY AND UNIFY QUANDRA FAMILY OF CRT-DS (P030054/S248) | ABBOTT MEDICAL | 2013-06-12 |
| FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICDS (P910023/S318) | ABBOTT MEDICAL | 2013-06-12 |
| UNIFY, UNIFY ASSURA, QUADRA ASSURA FAMILY OF CRT-D'S (P030054/S250) | ABBOTT MEDICAL | 2013-06-12 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S108) | Cochlear Americas | 2013-06-12 |
| NATRELLE SALINE-FILLED BREAST IMPLANTS (P990074/S026) | Allergan | 2013-06-12 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL (P870077/S051) | Edwards Lifesciences, LLC | 2013-06-11 |
| GEM,JEWEL,MOCRO JEWEL,JEWEL PLUS,MICRO JEWEL II,PCD (P900061/S121) | Medtronic Cardiac Rhythm Disease Management | 2013-06-11 |
| KAPPA 800, KAPPA 900, KAPPA 650, KAPPA 700, KAPPA800, KAPPA 900, RELIA, SENSIA, SIGMA, VERSA JEWEL AF GEM III AT (P980035/S321) | Medtronic, Inc. | 2013-06-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S019) | Edwards Lifesciences, LLC | 2013-06-11 |
| ELITE, ELITE II, MINUET, PREVA, PREVA D, PRODIGY, SYNERGYST II, THERA, THERA-I, VITATRON LEGACY, VITATRON LEGACY II (P890003/S273) | Medtronic, Inc. | 2013-06-11 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORNARY STENT SYSTEM (P070015/S110) | Abbott Vascular, Inc. | 2013-06-11 |
| LEGEND PLUS (P930022/S015) | Medtronic, Inc. | 2013-06-11 |
| PASYS,PASYS ST,SPECTRAX S,SPECTAX SX,SPECTRAX SX-HT,SPECTRAX SXT,SYMBIOS,SYMBIOS(AA),SYNERGYST (P820003/S120) | Medtronic Cardiac Rhythm Disease Management | 2013-06-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S100) | Edwards Lifesciences, LLC | 2013-06-11 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONORY STENT SYSTEM (P110019/S046) | Abbott Vascular | 2013-06-11 |
| KAPPA 400 (P970012/S093) | Medtronic, Inc. | 2013-06-11 |
| ACTIVITRAX,ACTIVITRAX II,ACTIVITRAX E,LEGEND,LEGEND II,MICRO MINIX,MINIX ST,PREMIER,PREVAIL,VITATRON LEGACY (P850051/S080) | Medtronic, Inc. | 2013-06-11 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S056) | Edwards Lifesciences, LLC | 2013-06-11 |
| DIVA FAMILY INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE 11, VITA DDDR, VITA DDD AND VITA VVIR (P980050/S082) | Medtronic, Inc. | 2013-06-11 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S040) | Edwards Lifesciences, LLC | 2013-06-11 |