| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P870056/S049) | Edwards Lifesciences, LLC | 2012-05-30 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S043) | Boston Scientific Corp | 2012-05-30 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S073) | W. L. Gore & Associates, Inc. | 2012-05-30 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S038) | Spectranetics (Philips) | 2012-05-30 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S027) | W. L. Gore & Associates, Inc. | 2012-05-30 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S028) | W. L. Gore & Associates, Inc. | 2012-05-30 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S014) | Boston Scientific Corp | 2012-05-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P010041/S033) | Edwards Lifesciences, LLC | 2012-05-30 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S043) | W. L. Gore & Associates, Inc. | 2012-05-30 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S048) | W. L. Gore & Associates, Inc. | 2012-05-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P000007/S031) | Edwards Lifesciences, LLC | 2012-05-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P870077/S044) | Edwards Lifesciences, LLC | 2012-05-30 |
| EXPRESS MONORAIL OVER-THE-WIRE CORONARY STENT SYSTEM (P020009/S085) | Boston Scientific Scimed, Inc. | 2012-05-30 |
| ITREL 4 IMPLANTABLE NEUROSTIMULATION SYSTEM (P840001/S211) | Medtronic Neuromodulation | 2012-05-30 |
| PARADYM RF CRT-D (P060027/S041) | MicroPort CRM USA, Inc. | 2012-05-30 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S055) | Spectranetics Corp. | 2012-05-30 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S010) | Edwards Lifesciences, LLC | 2012-05-30 |
| PROGEL PLEURAL AIR LEAK SEALNAT (P010047/S020) | Neomend, Inc. | 2012-05-30 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S042) | W. L. Gore & Associates, Inc. | 2012-05-30 |
| PARADYM RF VR & RF DR ICD (P980049/S074) | MicroPort CRM USA, Inc. | 2012-05-30 |
| SIENTRA SILICONE GEL BREAST IMPLANTS (P070004/S003) | Tiger Aesthetics Medical, LLC | 2012-05-29 |
| SIENTRA SILICONE GEL BREAST IMPLANTS (P070004/S002) | Tiger Aesthetics Medical, LLC | 2012-05-29 |
| SIENTRA SILICONE GEL BREAST IMPLANTS (P070004/S001) | Tiger Aesthetics Medical, LLC | 2012-05-29 |
| MULTI-LINK VISION CORONARY STENT SYSTEMS (P020047/S041) | Abbott Vascular | 2012-05-25 |
| LIFESTENT SOLO VASCULAR STENT SYSTEM (P070014/S032) | Bard Peripheral Vascular, Inc. | 2012-05-25 |
| MULTI-LINK CORONARY STENT SYSTEMS (P970020/S070) | Abbott Vascular, Inc. | 2012-05-25 |
| TMR2000 HOLMIUM LASER SYSTEM (P970029/S019) | Cryolife, Inc. | 2012-05-25 |
| AMPLATZER SEPTAL OCCLUDER AND MULTI-FENESTRATED SEPTAL OCCLUDER (P000039/S045) | ABBOTT MEDICAL | 2012-05-24 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S133) | Boston Scientific Corp | 2012-05-24 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S036) | Spectranetics (Philips) | 2012-05-24 |
| DURATA LEADS (P950022/S078) | ABBOTT MEDICAL | 2012-05-24 |
| PRARDIGM REAL-TIME INSULIN PUMPS AND GUARDIAN REAL-TIME MONITOR (P980022/S116) | Medtronic Minimed | 2012-05-24 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S019) | Ortho-Clinical Diagnostics | 2012-05-24 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S020) | ABBOTT MEDICAL | 2012-05-24 |
| INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED (IDRT-TS) (P900033/S021) | Integra Lifesciences Corp. | 2012-05-24 |
| AMPLATZER DUCT OCCLUDER (P020024/S035) | ABBOTT MEDICAL | 2012-05-24 |
| MEDTRONIC RESTORESENSOR NEUROSTIMULATOR (P840001/S208) | Medtronic Neuromodulation | 2012-05-24 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S003) | Medtronic Vascular | 2012-05-24 |
| RESTYLANE INJECTABLE GEL (P040024/S059) | Q-Med AB | 2012-05-24 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S088) | Boston Scientific Corp | 2012-05-23 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S097) | Boston Scientific Corp | 2012-05-23 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S042) | Boston Scientific Corp | 2012-05-23 |
| REZOOM MULTIFOCAL INTRAOCULAR LENS, MODEL NXG1 (P960028/S036) | Johnson & Johnson Surgical Vision, Inc. | 2012-05-23 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S084) | Boston Scientific Scimed, Inc. | 2012-05-23 |
| TECNIS MULTIFOCAL INTRAOCULAR LENS, MODEL ZMA00 (P990080/S037) | Johnson & Johnson Surgical Vision, Inc. | 2012-05-23 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S087) | Boston Scientific Scimed, Inc. | 2012-05-23 |
| LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S031) | Alcon Laboratories, Inc. | 2012-05-23 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S036) | Boston Scientific Corp | 2012-05-23 |
| MAXIMO II DF4 & ICD, PROTECTA DF4 & ICD & XT DF4 & XT ICD, SECURA DF4 & ICD, VIRTUOSO II DR/VR ICD (P980016/S351) | Medtronic Cardiac Rhythm Disease Management | 2012-05-23 |
| RESTYLANE INJECTABLE GEL (P040024/S058) | Q-Med AB | 2012-05-23 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S052) | Boston Scientific Corp | 2012-05-23 |
| CONCERTO II CRT-D, CONSULTA & DF4, MAXIMO II CRT-D & DF4, PROTECTA CRT-D & DF4 & XT CRT-D & XT DF4 (P010031/S303) | Medtronic Cardiac Rhythm Disease Management | 2012-05-23 |
| REZOOM MULTIFOCAL INTRAOCULAR LENS, MODEL NXG1 (P080010/S008) | Johnson & Johnson Surgical Vision, Inc. | 2012-05-23 |
| TECNIS SOFT ACRYLIC INTRAOCULAR LENS, MODEL ZA9003 (P980040/S040) | Johnson & Johnson Surgical Vision, Inc. | 2012-05-23 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S034) | Boston Scientific | 2012-05-23 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDWIRE WITH WIRECLIP TORQUER (P900056/S114) | Boston Scientific Corp | 2012-05-23 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S027) | Boston Scientific Corp | 2012-05-23 |
| SMART NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM (P020036/S024) | Cordis US Corporation | 2012-05-22 |
| PRECISE NITINOL STENT SYSTEM (P030047/S025) | Cordis US Corporation | 2012-05-22 |
| SMART NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM (P020036/S025) | Cordis US Corporation | 2012-05-22 |
| LOTRAFILCON B SOFT CONTACT LENSES (P010019/S032) | Alcon Laboratories, Inc. | 2012-05-22 |
| CERVISTA HPV 16/18 (P080015/S007) | Hologic, Inc. | 2012-05-21 |
| CERVISTA HPV HR (P080014/S012) | Hologic, Inc. | 2012-05-21 |
| DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE 2 (HC2) HIGH RISK HPV DNA TEST (P890064/S027) | Qiagen Gaithersburg, Inc. | 2012-05-21 |
| INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S258) | Boston Scientific | 2012-05-18 |
| INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S288) | Boston Scientific Corp | 2012-05-18 |
| CONTAK RENEWAL TR CRT-P DEVICES (P030005/S083) | Guidant Corp. | 2012-05-18 |
| CONCEPTUS ESSURE SYSTEM (P020014/S037) | Bayer Pharma AG | 2012-05-17 |
| COAPTITE INJECTABLE IMPLANT (P040047/S021) | Merz North America, Inc. | 2012-05-17 |
| HEARTMATE II VENTRICULAR ASSISTE SYSTEM (P060040/S017) | ABBOTT MEDICAL | 2012-05-17 |
| GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S051) | ABBOTT MEDICAL | 2012-05-17 |
| MEDTRONIC MINIMED CONTIUOUS GLUCOSE MONITORING SYSTEM (P980022/S117) | Medtronic Minimed | 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 |
| DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM (P950037/S108) | Biotronik, Inc. | 2012-05-17 |
| ADEPT ADHESION REDUCTION SOLUTION (P050011/S003) | Baxter Healthcare Corp | 2012-05-17 |
| COAPTITE INJECTABLE IMPLANT (P040047/S018) | Merz North America, Inc. | 2012-05-17 |
| LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S030) | Alcon Laboratories, Inc. | 2012-05-16 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S011) | Syncardia Systems, LLC | 2012-05-16 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S037) | Spectranetics (Philips) | 2012-05-16 |
| AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P060022/S013) | Bausch & Lomb, Inc. | 2012-05-16 |
| AMVISC & AMVISC PLUS (P810025/S028) | Bausch & Lomb, Inc. | 2012-05-15 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2900, 3000TFX, 3300TFX (P860057/S088) | Edwards Lifesciences, LLC | 2012-05-15 |
| BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P080011/S011) | CooperVision, Inc. | 2012-05-11 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S009) | LeMaitre Vascular, Inc. | 2012-05-11 |
| SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S010) | Lenstec, Inc. | 2012-05-11 |
| PROMUS ELEMENT PLUS EVEROLIMUS PLATINUM CHRONIUM CORONARY STENT SYSTEM (P110010/S004) | Boston Scientific Corp | 2012-05-11 |
| LOTRAFILCON B SOFT CONTACT LENSES (P010019/S028) | Alcon Laboratories, Inc. | 2012-05-11 |
| SJM CRTDS (P030054/S212) | ABBOTT MEDICAL | 2012-05-10 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S132) | Boston Scientific Corp | 2012-05-10 |
| SNS URINARY INS INTERSTIM FAMILY (P970004/S133) | Medtronic Neuromodulation | 2012-05-10 |
| SNS BOWEL INS INTERSTIM FAMILY (P080025/S030) | Medtronic Neuromodulation | 2012-05-10 |
| DEEP BRAIN STIMULATION (DBS) INS ACTIVA FAMILY, DBS ACCESSORIES, DBS INS SOLETRA FAMILY & DBS INS KINETRA FAMILY (P960009/S143) | Medtronic, Inc. | 2012-05-10 |
| SPINAL CORD STIMULATION (SCS) INPLANTABLE NEUROSTIMULATORS (INS) RESTORE FAMILY (P840001/S212) | Medtronic Neuromodulation | 2012-05-10 |
| TALENT CONVERTER STENT GRAFT SYSTEM AND TALENT OCCLUDER SYSTEM (P070027/S032) | Medtronic Vascular | 2012-05-10 |
| NEOMEND PROGEL PLEURAL AIR LEAK SEALANT (P010047/S011) | Neomend, Inc. | 2012-05-10 |
| MAXUM SYSTEM (P010023/S007) | Ototronix, LLC | 2012-05-10 |
| CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II M4, PROTECTA CRT-D, PROTECTA M4, PROTECTA XT CRT-D, PROTECTA XT M4 (P980016/S349) | Medtronic Cardiac Rhythm Disease Management | 2012-05-10 |
| SJM ICDS (P910023/S285) | ABBOTT MEDICAL | 2012-05-10 |
| CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II M4, PROTECTA CRT-D, PROTECTA M4, PROTECTA XT CRT-D, PROTECTA XT M4 (P010031/S301) | Medtronic Cardiac Rhythm Disease Management | 2012-05-10 |