| NEOMEND PROGEL PLEURAL AIR LEAK SEALANT (P010047/S006) | Neomend, Inc. | 2010-10-14 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S018) | Bard Peripheral Vascular, Inc. | 2010-10-14 |
| ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P960009/S097) | Medtronic, Inc. | 2010-10-14 |
| INTERSTIM II IMPLANTABLE NEUROSTIMULATORS (P970004/S093) | Medtronic Neuromodulation | 2010-10-14 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S165) | Medtronic Neuromodulation | 2010-10-14 |
| PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S089) | Medtronic Minimed | 2010-10-13 |
| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S006) | Boston Scientific Corporation | 2010-10-13 |
| VISIONCARE'S IMPLANTABLE MINIATURE TELESCOPE (P050034/S002) | Samsara Vision, Inc. | 2010-10-13 |
| REAL-TIME PUMP (P980022/S085) | Medtronic Minimed | 2010-10-13 |
| ANGIO DYNAMICS 630PDT LASER (P990021/S002) | Pinnacle Biologics, Inc. | 2010-10-13 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S016) | Smith & Nephew, Inc. | 2010-10-13 |
| PARADIGM REAL-TIME SYSTEM (P980022/S081) | Medtronic Minimed | 2010-10-13 |
| VNS THERAPY SYSTEM (P970003/S114) | LivaNova USA, Inc. | 2010-10-13 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S048) | Abbott Vascular, Inc. | 2010-10-12 |
| PULSE GENERATOR (P010012/S257) | Boston Scientific Corp | 2010-10-08 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S016) | Boston Scientific Corp | 2010-10-08 |
| PULSE GENERATOR (P960040/S237) | Boston Scientific | 2010-10-08 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S020) | Medtimo, Inc. | 2010-10-08 |
| CAPSURE IMPLANTABLE PULSE GENERATOR (P890003/S200) | Medtronic, Inc. | 2010-10-08 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S108) | Boston Scientific Corp | 2010-10-08 |
| TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S013) | Cerenovus, Inc. | 2010-10-08 |
| SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (P050050/S001) | Djo Global | 2010-10-08 |
| HEARTMATE II LVAS (P060040/S013) | ABBOTT MEDICAL | 2010-10-08 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S053) | W. L. Gore & Associates, Inc. | 2010-10-08 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S109) | Boston Scientific Corp | 2010-10-08 |
| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S007) | Boston Scientific Corporation | 2010-10-08 |
| SEPRAFILM (P950034/S034) | Baxter Healthcare Corporation | 2010-10-07 |
| SYNCHROMED, SYNCHROMED EL AND SYNCHROMED II IMPLANTABLE INFUSION SYSTEMS (P860004/S140) | Medtronic, Inc. | 2010-10-07 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S006) | Hologic, Inc. | 2010-10-07 |
| SYNCHROMED EL/SYNCHROMED II/ISOMED PUMPS (P990034/S020) | Medtronic, Inc. | 2010-10-07 |
| VISIONCARE'S IMPLANTABLE MINIATURE TELESCOPE (P050034/S001) | Samsara Vision, Inc. | 2010-10-07 |
| HERCEPTEST KIT (P980018/S009) | Agilent Technologies Singapore (International) Pte , Ltd. | 2010-10-07 |
| CERVISTA HPV HR AND DNA EXTENSION KIT (P080014/S003) | Hologic, Inc. | 2010-10-06 |
| SIEMENS MAMMOMAT NOVATION FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM (P030010/S005) | Siemens Medical Solution | 2010-10-06 |
| SYNCHROMED, SYNCHROMED EL AND SYNCHROMED II IMPLANTABLE INFUSION SYSTEMS (P860004/S126) | Medtronic, Inc. | 2010-10-06 |
| ISOMED IMPLANTABLE INFUSION SYSTEMS (P990034/S018) | Medtronic, Inc. | 2010-10-06 |
| MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S083) | Medtronic Minimed | 2010-10-06 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S010) | Medtronic Vascular, Inc. | 2010-10-04 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S013) | Boston Scientific Corp | 2010-10-04 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S047) | Abbott Vascular, Inc. | 2010-10-04 |
| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S003) | Boston Scientific Corporation | 2010-10-04 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S072) | ABBOTT MEDICAL | 2010-10-01 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S192) | ABBOTT MEDICAL | 2010-10-01 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATOR (P970004/S092) | Medtronic Neuromodulation | 2010-10-01 |
| CADENCE FAMILY OF ICDS (P910023/S248) | ABBOTT MEDICAL | 2010-10-01 |
| SYNCHROMED DRUG PUMPS (P860004/S139) | Medtronic, Inc. | 2010-10-01 |
| ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S096) | Medtronic, Inc. | 2010-10-01 |
| CELSIUS CATHETER, NON-TEMPERATURE SENSING ABLATION CATHETERS, INTERFACE CABLES (P950005/S030) | Biosense Webster, Inc. | 2010-10-01 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S035) | ABBOTT MEDICAL | 2010-10-01 |
| NAVISTAR CATHETER, INTERFACE CABLES (P990025/S025) | Biosense Webster, Inc. | 2010-10-01 |
| NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS (P010068/S020) | Biosense Webster, Inc. | 2010-10-01 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S048) | Med-El Corp. | 2010-10-01 |
| CELSIUS THERMOCOOL & NAVISTAR THERMOCOOL (P030031/S028) | Biosense Webster, Inc. | 2010-10-01 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (INS) (P840001/S164) | Medtronic Neuromodulation | 2010-10-01 |
| CONTRAK RENEWAL TR/TR2 PULSE GENERATOR (P030005/S071) | Guidant Corp. | 2010-10-01 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S014) | ABBOTT MEDICAL | 2010-10-01 |
| NAVISTAR THERMOCOOL (P040036/S021) | Biosense Webster, Inc. | 2010-10-01 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S167) | ABBOTT MEDICAL | 2010-10-01 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S068) | St. Jude Medical, Inc. | 2010-10-01 |
| EZ STEER THERMOCOOL CATHETERS (P990071/S010) | Biosense Webster, Inc. | 2010-10-01 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S003) | Boston Scientific Corp | 2010-09-30 |
| THORATEC HEARTMATE2 LVAS (P060040/S008) | ABBOTT MEDICAL | 2010-09-30 |
| AMSUROLUME ENDOPROSTHESIS (P920023/S027) | Boston Scientific Corp | 2010-09-30 |
| MAXUM SYSTEM (P010023/S003) | Ototronix, LLC | 2010-09-30 |
| VIRTUOSO, VIRTUOSO 2, SECURA AND MAXIMO 2 (P010031/S208) | Medtronic Cardiac Rhythm Disease Management | 2010-09-29 |
| LATITUDE COMMUNICATORS & PROGRAMMER (P910077/S107) | Boston Scientific | 2010-09-29 |
| CONCERTO, CONCERTO2 CONSULTA AND MAXIMO 2 (P980016/S252) | Medtronic Cardiac Rhythm Disease Management | 2010-09-29 |
| RELIANCE LEADS (P910073/S084) | Boston Scientific | 2010-09-28 |
| BIO-RAD MONOLISA ANTI -HBS EIA (P050048/S006) | Bio-Rad Laboratories | 2010-09-27 |
| TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S012) | Cerenovus, Inc. | 2010-09-27 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S013) | Allergan | 2010-09-24 |
| VISTAKON (SENOFILCON A) CONTACT LENSES/CLEAR/VISIBILITY TINTED WITH UV BLOCKER (P040045/S015) | Vistakon, Division of Johnson & Johnson Vision Car | 2010-09-24 |
| QUICKFLEX FAMILY OF LEFT HEART LEADS (P030054/S170) | ABBOTT MEDICAL | 2010-09-24 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S098) | Boston Scientific Corp | 2010-09-23 |
| UROLUME ENDOPROSTHESIS (P920023/S028) | Boston Scientific Corp | 2010-09-23 |
| EPIC/+/II, ATLAS/+/II, CURRENT/CURRENT+ AND PROMOTE+ FAMILY OF DEVICES (P030054/S165) | ABBOTT MEDICAL | 2010-09-23 |
| FORTIFY VR/DR (P910023/S239) | ABBOTT MEDICAL | 2010-09-23 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 411 IMMUNOASSAY ANALYZER (P090007/S001) | Roche Diagnostics Corp. | 2010-09-23 |
| ON-X PROSTHETIC HEART VALVE (P000037/S019) | On-X Life Technologies, Inc. | 2010-09-23 |
| EPIC/+/II, ATLAS/+/II, CURRENT/CURRENT+ AND PROMOTE+ FAMILY OF DEVICES (P910023/S246) | ABBOTT MEDICAL | 2010-09-23 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER (P090009/S001) | Roche Diagnostics Corp. | 2010-09-23 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 601 IMMUNOASSAY ANALYZER (P090008/S001) | Roche Diagnostics Corp. | 2010-09-23 |
| UNIFY CRT-D (P030054/S157) | ABBOTT MEDICAL | 2010-09-23 |
| AMPLICOR HCV TEST (P000010/S017) | Roche Molecular Systems, Inc. | 2010-09-23 |
| COBAS AMPLIPREP/COBAS AMPLICOR HVC TEST (P000012/S025) | Roche Molecular Systems, Inc. | 2010-09-23 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S014) | Roche Molecular Systems, Inc. | 2010-09-22 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S044) | Alcon Laboratories, Inc. | 2010-09-22 |
| EASYTRAK (P010012/S253) | Boston Scientific Corp | 2010-09-22 |
| PMMA SINGLE-PIECE ANTERIOR CHAMBER IOLS (P880087/S018) | Alcon Laboratories | 2010-09-22 |
| ACRYSOF INTRAOCULAR LENSES (P040020/S027) | Alcon Research, Ltd. | 2010-09-22 |
| THINLINE/FINELINE (P960004/S046) | Boston Scientific | 2010-09-22 |
| ACUITY STEERABLE/SPIRAL (P050046/S007) | Guidant Corp. | 2010-09-22 |
| TELIGEN HE DR/VR /CONFIENT (P960040/S233) | Boston Scientific | 2010-09-22 |
| PMMA INTRAOCULAR LENSES (P810032/S059) | Alcon Laboratories | 2010-09-22 |
| HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S033) | CooperSurgical, Inc. | 2010-09-22 |
| PMMA INTRAOCULAR LENSES (P840060/S036) | Alcon Laboratories | 2010-09-22 |
| ESTEEM (P090018/S007) | Envoy Medical Corporation | 2010-09-21 |
| HANCOCK APICAL LEFT VENTRICLE CONNECTOR (P870078/S008) | Medtronic, Inc. | 2010-09-20 |
| AXSYM ANTI-HCV (P970027/S009) | Abbott Laboratories | 2010-09-20 |
| PHILOS DR/SR/PHILOS II DR /SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/ENTOVIS DR PULSE GENERATORS (P950037/S086) | Biotronik, Inc. | 2010-09-17 |