| XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S065) | Abbott Vascular, Inc. | 2011-04-29 |
| ENDOTAK FAMILY (P910073/S096) | Boston Scientific | 2011-04-29 |
| CONTAK CD/EASYTRAK/LIVIAN/COGNIS/ACUITY SPIRAL FAMILIES (P010012/S266) | Boston Scientific Corp | 2011-04-29 |
| CONTAK RENEWAL TR FAMILY (P030005/S074) | Guidant Corp. | 2011-04-29 |
| RES-Q/RES-Q MICRON FAMILIES (P940008/S027) | Boston Scientific | 2011-04-29 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S005) | Bio-Rad Laboratories, Inc. | 2011-04-28 |
| IMMULITE/IMMULITE 2000 PSA (P930027/S011) | Siemens Healthcare Diagnostics, Inc. | 2011-04-26 |
| IMMULITE/IMMULITE 2000 AFP (P010007/S005) | Siemens Healthcare Diagnostics, Inc. | 2011-04-26 |
| IMMULITE/IMMULITE 2000 FREE PSA (P060005/S004) | Siemens Medical Solutions Diagnostics Limited | 2011-04-26 |
| BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S004) | Bio-Rad Laboratories | 2011-04-25 |
| CADENCE ICDS (P910023/S253) | ABBOTT MEDICAL | 2011-04-25 |
| EPIC HF CRT-DS (P030054/S176) | ABBOTT MEDICAL | 2011-04-25 |
| RESTORE FAMILY OF NEUROSTIMULATORS (P840001/S159) | Medtronic Neuromodulation | 2011-04-22 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S021) | Ortho-Clinical Diagnostics, Inc. | 2011-04-22 |
| STELKAST SURPASS ACETABULAR SYSTEM (P040051/S002) | Stelkast Company | 2011-04-22 |
| ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS) (P100023) | Boston Scientific Corp | 2011-04-22 |
| ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S090) | Medtronic, Inc. | 2011-04-22 |
| ABBOTT ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS (P060007/S012) | Abbott Laboratories | 2011-04-21 |
| AXSYM CORE 2.0 (P060012/S007) | Abbott Laboratories, Inc. | 2011-04-21 |
| FRESHLOOK (PHEMFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR (P830037/S052) | Alcon Laboratories, Inc. | 2011-04-21 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S058) | Therakos Development Limited | 2011-04-21 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S042) | Spectranetics Corp. | 2011-04-20 |
| RELIATY / MODEL 3145 FAMILY OF PACING SYSTEM ANALYZERS (P950037/S088) | Biotronik, Inc. | 2011-04-20 |
| DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE CAPTURE 2 (HC2) HIGH HPV DNA TEST (P890064/S026) | Qiagen Gaithersburg, Inc. | 2011-04-20 |
| ST JUDE MEDICAL TRIFECTA VALVE (P100029) | ABBOTT MEDICAL | 2011-04-20 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S063) | Medtronic, Inc. | 2011-04-20 |
| GORE VIABAHN ENDOPROSTHESIS & GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S033) | W. L. Gore & Associates, Inc. | 2011-04-20 |
| COBAS HPV TEST (P100020) | Roche Molecular Systems, Inc. | 2011-04-19 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S025) | Medtronic Vascular | 2011-04-19 |
| VNS THERAPY SYSTEM (P970003/S124) | LivaNova USA, Inc. | 2011-04-19 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S023) | Zoll Manufacturing Corporation | 2011-04-19 |
| PATHVYSION HER-2 DNA PROBE KIT (P980024/S005) | Abbott Molecular, Inc. | 2011-04-18 |
| HERCEPTEST (P980018/S013) | Agilent Technologies Singapore (International) Pte , Ltd. | 2011-04-18 |
| FREESTYLE AORTICROOT BIOPROSTHESIS (P970031/S032) | Medtronic, Inc. | 2011-04-15 |
| IMPLANTABLE CV DEFIBRILLATOR/PACEMAKER PROGRAMMER/ICD MONITORING SYSTEM (P000009/S042) | Biotronik, Inc. | 2011-04-15 |
| AXSYM ANTI-HCV (P970027/S013) | Abbott Laboratories | 2011-04-15 |
| AXSYM HBSAG/CONFIRMATORY (P050049/S006) | Abbott Laboratories, Inc. | 2011-04-15 |
| LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T (P050023/S039) | Biotronik, Inc. | 2011-04-15 |
| AXSYM CORE 2.0 (P060012/S006) | Abbott Laboratories, Inc. | 2011-04-15 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S030) | Medtronic, Inc. | 2011-04-15 |
| IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMING (P950037/S089) | Biotronik, Inc. | 2011-04-15 |
| AXSYM AUSAB (P060003/S008) | Abbott Laboratories, Inc. | 2011-04-15 |
| AXSYM CORE-M 2.0 (P060009/S004) | Abbott Laboratories, Inc. | 2011-04-15 |
| STRATOS LV/LV-T (P070008/S019) | Biotronik, Inc. | 2011-04-15 |
| MEDTRONIC REVO MRI SURESCAN PACING SYSTEM (P090013/S006) | Medtronic, Inc. | 2011-04-15 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S037) | Medtronic, Inc. | 2011-04-15 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S016) | Hologic, Inc. | 2011-04-14 |
| NEOMEND PROGEL PLEURAL AIR LEAK SEALANT (P010047/S009) | Neomend, Inc. | 2011-04-13 |
| ENDEAVOR SPRINT CORONARY STENT SYSTEM (P060033/S061) | Medtronic, Inc. | 2011-04-12 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S026) | Medtronic Vascular | 2011-04-12 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S060) | Medtronic, Inc. | 2011-04-12 |
| ANEURX AAADVANTAGE STENT GRAFT (P990020/S043) | Medtronic Vascular | 2011-04-12 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S050) | Medtronic, Ireland | 2011-04-12 |
| DRIVER/MICRO-DRIVER AND INTEGRITY CORONARY STENT SYSTEMS (P030009/S051) | Medtronic, Ireland | 2011-04-12 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S027) | Medtronic Vascular | 2011-04-12 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S018) | ABBOTT MEDICAL | 2011-04-08 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S061) | Abbott Vascular, Inc. | 2011-04-08 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S041) | ABBOTT MEDICAL | 2011-04-08 |
| ST JUDE MEDICAL MECHANICAL HEART VALVE/SJM MASTERS SERIES & SJM REGENT HEART VALVES (P810002/S073) | ABBOTT MEDICAL | 2011-04-08 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S017) | Hologic, Inc. | 2011-04-08 |
| NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT (P100034) | Novocure, GmbH | 2011-04-08 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM (P960040/S227) | Boston Scientific | 2011-04-08 |
| REPLY (P950029/S058) | MicroPort CRM USA, Inc. | 2011-04-08 |
| IMPLANTABLE PULSE GENERATOR, PACEMAKER (P010012/S247) | Boston Scientific Corp | 2011-04-08 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S066) | Terumo Medical Corporation | 2011-04-08 |
| MULTI-LINK VISION & MULTI-LINK MINI-VISION CORONARY STENT SYSTEM (P020047/S033) | Abbott Vascular | 2011-04-08 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S004) | Medtronic Cryocath, LP | 2011-04-08 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S061) | W. L. Gore & Associates, Inc. | 2011-04-08 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S062) | Abbott Vascular, Inc. | 2011-04-08 |
| AUTODELFIA HAFP KIT (P970037/S005) | Revvity, Inc. | 2011-04-08 |
| AMPLATZER DUCT OCCLUDER (P020024/S033) | ABBOTT MEDICAL | 2011-04-08 |
| MAXUM SYSTEM (P010023/S004) | Ototronix, LLC | 2011-04-08 |
| CONTAK RENEWAL TR (P030005/S067) | Guidant Corp. | 2011-04-08 |
| CHILLI COOLED ABLATION SYSTEM (P980003/S025) | Boston Scientific Corp | 2011-04-08 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S034) | Hologic, Inc. | 2011-04-08 |
| MULTI-LINK ZETA CORONARY STENT SYSTEMS (P970020/S062) | Abbott Vascular, Inc. | 2011-04-08 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S063) | Abbott Vascular, Inc. | 2011-04-08 |
| STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISIAN ICL) (P030016/S018) | STAAR Surgical Company | 2011-04-08 |
| UROVYSION BLADDER CANCER KIT (P030052/S005) | Abbott Molecular | 2011-04-08 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER, EASY EXCHANGE (EX0 (P050018/S013) | Spectranetics Corp. | 2011-04-08 |
| HOYA ISPHERIC INTRAOCULAR LENS (P080004/S006) | Hoya Surgical Optics, Inc. | 2011-04-07 |
| ACUITY SPIRAL LEAD (P010012/S264) | Boston Scientific Corp | 2011-04-07 |
| VISTAKON (ETAFILCON A) CONTACT LENSES/CLEAR & VISIBILITY TINTED WITH UV BLOCKER (N18033/S054) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2011-04-07 |
| ANJIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S035) | Boston Scientific Corp | 2011-04-07 |
| COCHLEAR NUCLEUS 5 COCHLEAR IMPLANT SYSTEM (P970051/S068) | Cochlear Americas | 2011-04-07 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S006) | Boston Scientific Corp | 2011-04-07 |
| EZ STEER NAV DS AND QWIKSTAR DS CATHETERS (P010068/S024) | Biosense Webster, Inc. | 2011-04-06 |
| NAVISTAR/RMT/EZ STEER NAV/QWIKSTAR/INTERFACE CABLES (P990025/S028) | Biosense Webster, Inc. | 2011-04-06 |
| MODEL 2490C/G/H/J CARELINK REMOTE HOME MONITOR/2020A ANALYZER (P890003/S217) | Medtronic, Inc. | 2011-04-06 |
| CELSIUS/RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION/INTERFACE CABLES (P950005/S034) | Biosense Webster, Inc. | 2011-04-06 |
| 1782 TENDRIL LEADS (P960013/S064) | ABBOTT MEDICAL | 2011-04-06 |
| CELSIUS THERMOCOOL/RMT//NAVISTAR/NAVISTAR RMT/EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS (P030031/S032) | Biosense Webster, Inc. | 2011-04-06 |
| APLIGRAF (P950032/S063) | Organogenesis, Inc. | 2011-04-06 |
| NAVISTAR THERMOCOOL//NAVISTAR RMT//EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS (P040036/S023) | Biosense Webster, Inc. | 2011-04-06 |
| INTERFACE CABLES (P990071/S012) | Biosense Webster, Inc. | 2011-04-06 |
| EVIA FAMILY OF PULSE GENERATORS (P950037/S094) | Biotronik, Inc. | 2011-04-06 |
| PIPELINE EMBOLIZATION DEVICE (P100018) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2011-04-06 |
| SCULPTRA (P030050/S007) | Q-Med AB | 2011-04-05 |
| GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S034) | Gynecare, Inc. | 2011-04-05 |
| MYNX CADENCE VASCULAR CLOSURE DEVICE (P040044/S037) | Cordis US Corporation | 2011-04-05 |