| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S007) | Syncardia Systems, LLC | 2010-04-28 |
| SELECTSECURE (P030036/S016) | Medtronic Cardiac Rhythm Disease Management | 2010-04-28 |
| CONCERTO/II/CONSULTA/INSYNC ICD/MARQUIS/MAXIMO/INSYNC II/MARQUIS/MAXIMO II/INSYNC II PROTECT/III MARQUIS/SENTRY (P010031/S192) | Medtronic Cardiac Rhythm Disease Management | 2010-04-28 |
| IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT/FIDELIS/QUATTRO/SUBCUTANEOUS LEAD/SUB-Q DEFIBRILLAION LEAD/TRANSVENE CS/SVC LEAD (P920015/S059) | Medtronic, Inc. | 2010-04-28 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S049) | Medtronic, Inc. | 2010-04-28 |
| ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN (P900061/S088) | Medtronic Cardiac Rhythm Disease Management | 2010-04-28 |
| TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) MODEL ZMA00 (P080010/S005) | Johnson & Johnson Surgical Vision, Inc. | 2010-04-28 |
| CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II (P980016/S233) | Medtronic Cardiac Rhythm Disease Management | 2010-04-28 |
| CLARITY/DA+ C-SERIES/T-SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/SELECTION AFM/TOPAZ 3/II/VITA/2 (P990001/S065) | Medtronic, Inc. | 2010-04-28 |
| 350 SERIES/ADAPTA/AT500/ENPULSE/ENRHYTHM/KAPPA 600/700/800/900/RELIA/SENSIA/VERSA/SIGMA (P980035/S163) | Medtronic, Inc. | 2010-04-28 |
| CAPSURE/VITATRON CRYSTALINE/EXCELLENCE+/EXCELLENCE PS+ (P830061/S050) | Medtronic Cardiac Rhythm Disease Management | 2010-04-28 |
| ATTAIN STARFIX (P060039/S011) | Medtronic, Inc. | 2010-04-28 |
| CAPSURE/CAPSURE MODEL/PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT/THERA-I/VITATRON LEGACY/LEGACY II/VISA (P890003/S187) | Medtronic, Inc. | 2010-04-28 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S103) | Boston Scientific Corp | 2010-04-28 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S008) | Medtronic Vascular, Inc. | 2010-04-28 |
| CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+ (P930039/S036) | Medtronic, Inc. | 2010-04-28 |
| KAPPA 400 (P970012/S066) | Medtronic, Inc. | 2010-04-28 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S020) | Medtronic, Inc. | 2010-04-28 |
| ATTAIN/INSYNC/INSYNC III (P010015/S083) | Medtronic, Inc. | 2010-04-28 |
| ATTAIN (P080006/S007) | Medtronic, Inc. | 2010-04-28 |
| JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD (P980050/S048) | Medtronic, Inc. | 2010-04-28 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S069) | Boston Scientific Corp | 2010-04-27 |
| OVATIO VR/DR (P980049/S053) | MicroPort CRM USA, Inc. | 2010-04-27 |
| OVATIO CRT-D (P060027/S019) | MicroPort CRM USA, Inc. | 2010-04-27 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032) | Boston Scientific Corp | 2010-04-27 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S024) | Boston Scientific Corp | 2010-04-27 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S011) | Siemens Healthcare Diagnostics | 2010-04-26 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S016) | Siemens Healthcare Diagnostics | 2010-04-26 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P030035/S067) | ABBOTT MEDICAL | 2010-04-23 |
| AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST (P940034/S018) | Gen-Probe, Inc. | 2010-04-23 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S147) | ABBOTT MEDICAL | 2010-04-23 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S060) | Cochlear Americas | 2010-04-23 |
| FETAL ACOUSTIC STIMULATOR (FAST) (P870025/S009) | Ge Medical Systems, Inc. | 2010-04-23 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S033) | Abbott Vascular, Inc. | 2010-04-23 |
| MULTI-LINK ZETA CORONARY STENT SYSTEMS (CSS) (P970020/S055) | Abbott Vascular, Inc. | 2010-04-23 |
| MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS VISION/MINI VISION (P020047/S018) | Abbott Vascular | 2010-04-23 |
| AMS 800 ARTIFICAL URINARY SPHINCTER (P000053/S028) | Boston Scientific Corp | 2010-04-23 |
| CADENCE FAMILY OF ICDS (P910023/S231) | ABBOTT MEDICAL | 2010-04-23 |
| ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S015) | Boston Scientific Corp | 2010-04-23 |
| SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETERS VOYAGER/VOYAGER NC (P810046/S236) | Advanced Cardiovascular Systems, Inc. | 2010-04-23 |
| VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S003) | Gen-Probe | 2010-04-23 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P880086/S186) | ABBOTT MEDICAL | 2010-04-23 |
| GENESYS HTA SYSTEM (P000040/S014) | Axora Medical, Inc. | 2010-04-23 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S012) | ABBOTT MEDICAL | 2010-04-22 |
| AMPLATZER SEPTAL OCCLUDER AND AMPLATZER EXCHANGE SYSTEM (P000039/S035) | ABBOTT MEDICAL | 2010-04-22 |
| STAR CLOSE AND STAR CLOSE SE VASCULAR CLOSURE SYSTEMS (P050007/S024) | Abbott Vascular Devices | 2010-04-22 |
| MAVERICK 2 MONORAIL PTCA CATHETER (P860019/S253) | Scimed Life Systems, Inc. | 2010-04-22 |
| AMPLATZER DUCT OCCLUDER (P020024/S028) | ABBOTT MEDICAL | 2010-04-22 |
| ISOLINE 2CR AND ISOLINE 2CT LEADS (P980049/S055) | MicroPort CRM USA, Inc. | 2010-04-22 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S017) | Smiths Medical Asd, Inc. | 2010-04-21 |
| SPRINTER LEGEND RX BALLOON DILATATION CATHETER (P790017/S107) | Medtronic, Ireland | 2010-04-21 |
| ADVIA CENTAUR HBSAG ASSAY (P030049/S008) | Siemens Healthcare Diagnostics | 2010-04-20 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S014) | DePuy Orthopaedics, Inc. | 2010-04-20 |
| THORATEC HEARTMATE 2 LVAS (P060040/S006) | ABBOTT MEDICAL | 2010-04-19 |
| EXABLATE 2100 SYSTEM (P040003/S007) | Insightec, Ltd. | 2010-04-19 |
| NC QUANTUM APEX MONORAIL AND OVER-THE-WIRE PTCA CATHETERS (P860019/S241) | Scimed Life Systems, Inc. | 2010-04-16 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3 FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S149) | Medtronic Neuromodulation | 2010-04-16 |
| SYNCHROMED FAMILY OF IMPLANTABLE FUSION PUMPS (P860004/S124) | Medtronic, Inc. | 2010-04-16 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD& KIT (P970004/S083) | Medtronic Neuromodulation | 2010-04-16 |
| MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S049) | Medtronic, Inc. | 2010-04-16 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S011) | Bard Peripheral Vascular | 2010-04-16 |
| ISOMED INFUSION PUMPS (P990034/S017) | Medtronic, Inc. | 2010-04-16 |
| TELIGEN PULSE GENERATORS MODELS E110 (P960040/S219) | Boston Scientific | 2010-04-15 |
| VENTAK (CONFIENT/TELIGEN/VITALITY) (P960040/S220) | Boston Scientific | 2010-04-15 |
| CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM (P970029/S017) | Cryolife, Inc. | 2010-04-15 |
| NEOMEND PROGEL PLEURAL AIR LEAK SEALANT (P010047/S002) | Neomend, Inc. | 2010-04-15 |
| UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S050) | Urologix, LLC | 2010-04-15 |
| COGNIS/LIVIAN/RENEWAL 3 FAMILIES (P010012/S239) | Boston Scientific Corp | 2010-04-15 |
| COGNIS PULSE GENERATORS MODELS N118 & N119 (P010012/S238) | Boston Scientific Corp | 2010-04-15 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S002) | Hologic, Inc. | 2010-04-15 |
| TENDRIL STS LEAD MODEL 1988TC (P960013/S054) | ABBOTT MEDICAL | 2010-04-14 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S051) | W. L. Gore & Associates, Inc. | 2010-04-14 |
| VNS THERAPY SYSTEM (P970003/S108) | LivaNova USA, Inc. | 2010-04-14 |
| INTERSTIM THERAPY SYSTEM (P970004/S079) | Medtronic Neuromodulation | 2010-04-13 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S011) | Bard Peripheral Vascular, Inc. | 2010-04-13 |
| CIBA VISION (VASURFILCON A) SOFT CONTACT LENSES (P940013/S010) | Alcon Laboratories, Inc. | 2010-04-13 |
| LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022) | Lenstec, Inc. | 2010-04-12 |
| ZILVER VASCULAR STENT AND SILVER VASCULAR STENT (P050017/S005) | Cook Ireland, Ltd. | 2010-04-12 |
| APLIGRAF (P950032/S057) | Organogenesis, Inc. | 2010-04-09 |
| APLIGRAF (P950032/S056) | Organogenesis, Inc. | 2010-04-09 |
| AMPLICOR HCV TEST, VERSION 2.0 (P000010/S015) | Roche Molecular Systems, Inc. | 2010-04-08 |
| COBAS TAQMAN HBV TEST (P050028/S006) | Roche Molecular Systems, Inc. | 2010-04-08 |
| GELFOAM (ABSORBABLE GELATIN) PLUS HEMOSTATIS KIT (N18286/S019) | Pfizer, Inc. | 2010-04-08 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S007) | Roche Molecular Systems, Inc. | 2010-04-08 |
| QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM) (P080029) | Cardiva Medical, Inc. | 2010-04-08 |
| EON IMPLANTABLE PULSE GENERATOR (IPG) NEUROSTIMULATION SYSTEM (P010032/S032) | ABBOTT MEDICAL | 2010-04-08 |
| COBAS AMPLICOR HCV TEST AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.0 (P000012/S022) | Roche Molecular Systems, Inc. | 2010-04-08 |
| AMPLICOR HCV TEST (P000010/S016) | Roche Molecular Systems, Inc. | 2010-04-07 |
| RESTYLANE INJECTABLE GEL (P040024/S045) | Q-Med AB | 2010-04-07 |
| COOLFLOW TUBING IFU (P990071/S011) | Biosense Webster, Inc. | 2010-04-07 |
| PARADYM VR MODEL 8250 & DR MODEL 8550 (P980049/S050) | MicroPort CRM USA, Inc. | 2010-04-07 |
| PARADYM CRT-D MODEL 8750 (P060027/S015) | MicroPort CRM USA, Inc. | 2010-04-07 |
| BIOFINITY (COMFILCON A) SOFT CONTACT LENS FOR EXTEND WEAR (P080011/S003) | CooperVision, Inc. | 2010-04-07 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S101) | Boston Scientific Corp | 2010-04-06 |
| CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S029) | Bayer Pharma AG | 2010-04-06 |
| THORATEC HEARTMATE 2 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S007) | ABBOTT MEDICAL | 2010-04-06 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S009) | Boston Scientific Corp | 2010-04-06 |
| MAVERICK XL PTCA DILATATION CATHETER (P860019/S251) | Scimed Life Systems, Inc. | 2010-04-06 |
| LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S102) | Boston Scientific | 2010-04-06 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S039) | Boston Scientific Corp | 2010-04-06 |