| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S012) | Hologic, Inc. | 2011-03-09 |
| ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S109) | Medtronic, Inc. | 2011-03-09 |
| ITREL 3/SYNERGY/SYNERGY VERSITREL IPG/RESTOREPRIME/PRIMEADVANCED/RESTORE/RESTOREULTRA/RESTOREADVANCED INS (P840001/S180) | Medtronic Neuromodulation | 2011-03-09 |
| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S009) | Boston Scientific Corporation | 2011-03-09 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S031) | Hologic, Inc. | 2011-03-09 |
| SOLETRA/KINETRA/ACTIVA PC/ACTIVA RC INS (P960009/S110) | Medtronic, Inc. | 2011-03-09 |
| INTERSTIM/INTERSTIM II INS (P970004/S106) | Medtronic Neuromodulation | 2011-03-09 |
| RESTORE IMPLANTABLE NEUROSTIMULATORS (P840001/S179) | Medtronic Neuromodulation | 2011-03-09 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S003) | Medtronic Cryocath, LP | 2011-03-09 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATORS (P970004/S105) | Medtronic Neuromodulation | 2011-03-09 |
| ACRYSOF IQ TORIC INTRAOCULAR LENSES (P930014/S047) | Alcon Laboratories, Inc. | 2011-03-09 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEMS (P060001/S011) | Medtronic Vascular, Inc. | 2011-03-08 |
| BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC (P960011/S018) | Altacor , Ltd. | 2011-03-08 |
| SLS II SPECTRANETICS LASER SHEATHS (P960042/S028) | Spectranetics (Philips) | 2011-03-07 |
| ARCHITECT TOTAL PSA (P910007/S027) | Abbott Laboratories | 2011-03-07 |
| ARCHITECT FREE PSA (P980007/S018) | Abbott Laboratories | 2011-03-07 |
| SURGICEL ORIGINAL/SURGICEL FIBRILLAR/SURGICEL NU-KNIT ABSORBABLE HEMOSTATS (N12159/S027) | ETHICON, Inc. | 2011-03-04 |
| FRONTIER/FRONTIER 2 FAMILY OF CRT-PS (P030035/S070) | ABBOTT MEDICAL | 2011-03-04 |
| EPIC HR/ATLAS + HF FAMILY OF CRT-DS (P030054/S153) | ABBOTT MEDICAL | 2011-03-04 |
| CADENCE FAMILY OF ICDS (P910023/S236) | ABBOTT MEDICAL | 2011-03-04 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S189) | ABBOTT MEDICAL | 2011-03-04 |
| WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.68 (P930016/S034) | Amo Manufacturing USA, LLC | 2011-03-04 |
| SENSLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S067) | St. Jude Medical, Inc. | 2011-03-04 |
| AUTODELFIA/DELFIA XPRESS HAFP (P970037/S004) | Revvity, Inc. | 2011-03-04 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S034) | ABBOTT MEDICAL | 2011-03-04 |
| BAUSCH & LOMB SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENSES (N16895/S093) | Bausch & Lomb, Inc. | 2011-03-04 |
| PRODISC-L TOTAL DISC REPLACEMENT (P050010/S010) | Centinel Spine, LLC | 2011-03-03 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S056) | Abbott Vascular, Inc. | 2011-03-03 |
| NAVISTAR RMT CATHETER (P990025/S027) | Biosense Webster, Inc. | 2011-03-03 |
| NAVISTAR THERMOCOOL CATHETER FAMILY (P040036/S016) | Biosense Webster, Inc. | 2011-03-03 |
| LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S110) | Boston Scientific | 2011-03-03 |
| ADAPTA/RELIA/SENSIA/VERSA IPGS (P980035/S203) | Medtronic, Inc. | 2011-03-03 |
| NAVISTAR THERMOCOOL CATHETER FAMILY (P030031/S023) | Biosense Webster, Inc. | 2011-03-03 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081) | Cordis Corp. | 2011-03-03 |
| GLUTARALDEHYDE SOLUTION SYSTEM (P860057/S076) | Edwards Lifesciences, LLC | 2011-03-03 |
| WEBSTER ELECTROPHYSIOLOGY CATHETER/CELSIUS ABLATION CATHETER (P950005/S032) | Biosense Webster, Inc. | 2011-03-03 |
| SYNCHROMED II INFUSION SYSTEM (P860004/S138) | Medtronic, Inc. | 2011-03-03 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S028) | Medtronic Vascular | 2011-03-03 |
| REPLY SR/DR & ESPIRIT SR/DR (P950029/S057) | MicroPort CRM USA, Inc. | 2011-03-03 |
| CELSIUS DS ABLATION CATHETER (P010068/S022) | Biosense Webster, Inc. | 2011-03-03 |
| UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S055) | Urologix, LLC | 2011-03-02 |
| DEXCOM SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM (P050012/S036) | Dexcom, Inc. | 2011-03-02 |
| SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P. (P990004/S021) | Ferrosan Meidcal Devices A/S | 2011-03-02 |
| MAXUM SYSTEM (P010023/S008) | Ototronix, LLC | 2011-03-02 |
| VNS THERAPY SYSTEM (P970003/S122) | LivaNova USA, Inc. | 2011-03-02 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S067) | Cochlear Americas | 2011-03-02 |
| CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S234) | Medtronic Cardiac Rhythm Disease Management | 2011-03-02 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS (P980016/S278) | Medtronic Cardiac Rhythm Disease Management | 2011-03-02 |
| GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S014) | ETHICON, Inc. | 2011-03-02 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S057) | Boston Scientific Corp | 2011-03-01 |
| LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS (P980023/S043) | Biotronik, Inc. | 2011-02-28 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S044) | Spectranetics Corp. | 2011-02-28 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S026) | Spectranetics (Philips) | 2011-02-28 |
| VNS THERAPY SYSTEM (P970003/S121) | LivaNova USA, Inc. | 2011-02-28 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S014) | Ortho-Clinical Diagnostics | 2011-02-28 |
| GYNECARE THERMACHOICE III UTERINE THERAPY SYSTEM (P970021/S033) | Gynecare, Inc. | 2011-02-25 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S017) | Stryker Corp. | 2011-02-25 |
| CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S008) | Ceramtec GmbH | 2011-02-25 |
| VITATRON DA+C-SERIES/VITATRON DA+T SERIES (P990001/S083) | Medtronic, Inc. | 2011-02-24 |
| PRODIGY (P890003/S212) | Medtronic, Inc. | 2011-02-24 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/SECURA/VIRTUOSO/VIRTUOSO II (P980016/S277) | Medtronic Cardiac Rhythm Disease Management | 2011-02-24 |
| CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S032) | Bayer Pharma AG | 2011-02-24 |
| CONCERTO/CONCERTO II/CONSULTA/INSYNC II MARQUIS/INSYNC III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO II (P010031/S233) | Medtronic Cardiac Rhythm Disease Management | 2011-02-24 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S013) | Roche Molecular Systems, Inc. | 2011-02-24 |
| GORE TAG THORACIC ENDOPROSTESIS (P040043/S037) | W. L. Gore & Associates, Inc. | 2011-02-24 |
| EON WALL CHARGER KIT (P010032/S037) | ABBOTT MEDICAL | 2011-02-24 |
| 350 SERIES/ADAPTA/AT500/ENPULSE/ENRHYTHM/KAPPA 700/800/900/RELIA/SENSIA/SIGMA/VERSA (P980035/S201) | Medtronic, Inc. | 2011-02-24 |
| INSYNC/INSYNC II (P010015/S108) | Medtronic, Inc. | 2011-02-24 |
| COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM (P060030/S015) | Roche Molecular Systems, Inc. | 2011-02-24 |
| KAPPA 400 (P970012/S082) | Medtronic, Inc. | 2011-02-24 |
| DA+C SERIES & DA+T SERIES (P990001/S084) | Medtronic, Inc. | 2011-02-23 |
| ADAPTA/VERSA/SENSIA IPG/ENRHYTHM/RELIA IPG (P980035/S202) | Medtronic, Inc. | 2011-02-23 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILIES OF PACEMAKERS (P880086/S197) | ABBOTT MEDICAL | 2011-02-23 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II DR/II VR/SECURA DR/VR/VIRTUOSO/II DR/II VR (P980016/S279) | Medtronic Cardiac Rhythm Disease Management | 2011-02-23 |
| FRONTIER/FRONTIER II/ANTHEM FAMILIES OF CRT-PS (P030035/S077) | ABBOTT MEDICAL | 2011-02-23 |
| CONCERTO CRT-D/CONCERTO II ICD/CONSULTA CRT-D/INSYNC II MARQUIS/PROTECT/INSYNC III MARQUIS/INSYNC MARQUIS/INSYNC MAXIMO (P010031/S235) | Medtronic Cardiac Rhythm Disease Management | 2011-02-23 |
| BETA-CATH SYSTEM (P000018/S044) | Best Vascular, Inc. | 2011-02-23 |
| SAFIRE BLU IRRIGATED ABLATION CATHETER & THERAPY COOL PATH CATHETER (P060019/S009) | Irvine Biomedical, Inc. | 2011-02-23 |
| LCS TOTAL KNEE SYSTEM (P830055/S107) | Depuy, Inc. | 2011-02-22 |
| CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026) | Cordis Corp. | 2011-02-22 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S016) | ABBOTT MEDICAL | 2011-02-18 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S035) | W. L. Gore & Associates, Inc. | 2011-02-18 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S024) | Zoll Manufacturing Corporation | 2011-02-18 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S019) | W. L. Gore & Associates, Inc. | 2011-02-18 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S001) | OraSure Technologies, Inc. | 2011-02-18 |
| DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S003) | Integra LifeSciences Corporation | 2011-02-18 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S032) | Hologic, Inc. | 2011-02-18 |
| BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES (P960022/S007) | Bausch & Lomb, Inc. | 2011-02-18 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S010) | Syncardia Systems, LLC | 2011-02-18 |
| AMPLATZER SEPTAL & CRIBRIFORM OCCLUDERS (P000039/S039) | ABBOTT MEDICAL | 2011-02-18 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S065) | Terumo Medical Corporation | 2011-02-18 |
| GORE EXCULDER AAA ENDOPROSTHESIS (P020004/S058) | W. L. Gore & Associates, Inc. | 2011-02-18 |
| AMPLATZER DUCT OCCLUDER (P020024/S031) | ABBOTT MEDICAL | 2011-02-18 |
| NEOMEND'S PROGEL PLEURAL AIR LEAK SEALANT (P010047/S001) | Neomend, Inc. | 2011-02-17 |
| PARADIGM REAL-TIME SYSTEM (P980022/S087) | Medtronic Minimed | 2011-02-17 |
| THERAPY COOL PATH ABLATION CATHETER (P060019/S017) | Irvine Biomedical, Inc. | 2011-02-17 |
| ARCHITECT ANTI-HCV (P050042/S009) | Abbott Laboratories, Inc. | 2011-02-17 |
| HERCEPTEST KIT (P980018/S011) | Agilent Technologies Singapore (International) Pte , Ltd. | 2011-02-17 |
| THERAPY/THERAPY BI-DIRECTIONAL/THERAPY 4MM THERMISTOR ABLATION CATHETERS (P040014/S016) | Irvine Biomedical, Inc. | 2011-02-17 |
| THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS (P040042/S021) | Irvine Biomedical,Inc.(Ibi) | 2011-02-17 |