| RESTORE FAMILY OF NEUROSTIMULATION DEVICES (P840001/S136) | Medtronic Neuromodulation | 2009-06-08 |
| CORETHERM SYSTEM MICROWAVE THERMOTHERAPY (P010055/S006) | Prostalund AB | 2009-06-08 |
| ABBOTT ARCHITECT HBSAG (P060007/S003) | Abbott Laboratories | 2009-06-05 |
| EVOLENCE COLLAGEN FILLER (P070013/S003) | Colbar Lifescience , Ltd. | 2009-06-05 |
| FINELINE II/THINLINE II BRADY LEADS (P960004/S042) | Boston Scientific | 2009-06-05 |
| MODEL 4194 ATTAIN BIPOLAR OVER-THE-WIRE LEAD (P010015/S068) | Medtronic, Inc. | 2009-06-05 |
| IPULSE CIRCULATORY SUPPORT SYSTEM (P900023/S051) | Abiomed Cardiovascular, Inc. | 2009-06-05 |
| DIMENSION RXL MAX TPSA FLEX REAGENT CARTRIDGE (P000021/S014) | Siemens Healthcare Diagnostics | 2009-06-04 |
| MAMMOMAT NOVATION DR (P030010/S004) | Siemens Medical Solution | 2009-06-04 |
| TELIGEN ICDS (P960040/S196) | Boston Scientific | 2009-06-03 |
| COGNIS CRT-D (P010012/S210) | Boston Scientific Corp | 2009-06-03 |
| RESTORE PRIME, PRIMEADVANCED, RESTORE RECHARGEABLE, RESTORE ADVANCED AND RECHARGEABLE MODELS (P840001/S126) | Medtronic Neuromodulation | 2009-06-03 |
| IMMULITE / IMMULITE 1000 HBSAG ASSAY AND IMMULITE 2000 HBSAG ASSAY (P010050/S008) | Siemens Healthcare Diagnostics Products, Ltd. | 2009-06-02 |
| THERAPY ABLATION CATHETERS (P040014/S010) | Irvine Biomedical, Inc. | 2009-06-01 |
| SPECTRANETICS LASER SHEATH (SLS) (P960042/S013) | Spectranetics (Philips) | 2009-06-01 |
| EON NEUROSTIMULATION (IPG), ANS EON C NEUROSTIMULATION (IPG), AND EON MINI NEUROSTIMULATION(IPG) (P010032/S029) | ABBOTT MEDICAL | 2009-06-01 |
| THERAPY COOL PATH ABLATION CATHETERS (P060019/S008) | Irvine Biomedical, Inc. | 2009-06-01 |
| HYDRELLE (P050033/S007) | Anika Therapeutics, Inc. | 2009-06-01 |
| CVX-300 CORONARY LASER CATHETER (P910001/S031) | Spectranetics Corp. | 2009-06-01 |
| THERAPY DUAL 8 ABLATION CATHETERS (P040042/S015) | Irvine Biomedical,Inc.(Ibi) | 2009-06-01 |
| ARCHITECT TOTAL PSA ASSAY (P910007/S017) | Abbott Laboratories | 2009-05-29 |
| TITAN INFLATABLE PENILE PROSTHESIS (IPP) (P000006/S014) | Coloplast Corp. | 2009-05-29 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S016) | Abbott Vascular, Inc. | 2009-05-29 |
| ACRYSOF IQ RESTOR IOLS +3.0 D & +4.0 D ADD POWERS (P040020/S015) | Alcon Research, Ltd. | 2009-05-28 |
| MIGRATION OF THE ABBOTT ARCHITECT FREE PSA ASSAY TO THE NEW ARCHITECT I1000 SYSTEM (P980007/S009) | Abbott Laboratories | 2009-05-28 |
| ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY (P030049/S006) | Siemens Healthcare Diagnostics | 2009-05-27 |
| DEFLUX INJECTABLE GEL (P000029/S056) | Palette Life Sciences | 2009-05-27 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S006) | Srs Medical | 2009-05-27 |
| THERAKOS CELLEX* PHOTOPHERESIS SYSTEM (P860003/S053) | Therakos Development Limited | 2009-05-27 |
| SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) (P050050) | Djo Global | 2009-05-27 |
| TELIGEN FAMILY (P960040/S193) | Boston Scientific | 2009-05-26 |
| TENDRIL STS LEAD MODEL 2088TC (P960013/S046) | ABBOTT MEDICAL | 2009-05-26 |
| COGNIS CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR (P010012/S207) | Boston Scientific Corp | 2009-05-26 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S231) | Advanced Cardiovascular Systems, Inc. | 2009-05-26 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P060008/S017) | Boston Scientific Corp | 2009-05-26 |
| SOF-SENSOR GLUCOSE SENSOR (P980022/S054) | Medtronic Minimed | 2009-05-22 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S096) | Boston Scientific Corp | 2009-05-22 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S003) | Roche Molecular Systems, Inc. | 2009-05-22 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S016) | Boston Scientific Corp | 2009-05-22 |
| MORCHER CAPSULAR TENSION RINGS (P010059/S003) | Morcher GmbH | 2009-05-22 |
| VERSANT HCV RNA QUALITATIVE ASSAY AND THE APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S001) | Gen-Probe | 2009-05-22 |
| MMT-7335 CARELINK PRO PC SOFTWARE (P980022/S052) | Medtronic Minimed | 2009-05-22 |
| LEAD END CAP KIT/ LEAD ADAPTOR SLEEVE KIT/UPSIZING SLEEVE KIT (P900061/S083) | Medtronic Cardiac Rhythm Disease Management | 2009-05-21 |
| TENDRIL FAMILIES OF LEADS (P960013/S044) | ABBOTT MEDICAL | 2009-05-21 |
| PRIZM/VITALITY/CONFIENT FAMILIES (P960040/S194) | Boston Scientific | 2009-05-21 |
| LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S009) | Medtronic, Inc. | 2009-05-21 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S003) | Medtronic Vascular | 2009-05-21 |
| RENEWAL TR FAMILY (P030005/S057) | Guidant Corp. | 2009-05-21 |
| CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS (P980016/S184) | Medtronic Cardiac Rhythm Disease Management | 2009-05-21 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S003) | Medtronic Vascular | 2009-05-21 |
| CORETHERM SYSTEM MICROWAVE THERMOTHERAPY (P010055/S005) | Prostalund AB | 2009-05-21 |
| KAPPA 400 DR/SR IPG (P970012/S053) | Medtronic, Inc. | 2009-05-21 |
| MEDTRONIC / VITATRON CARELINK PROGRAMMING OPERATING SYSTEM AND MEDICAL DEVICE APPLICATION SOFTWARE (P890003/S168) | Medtronic, Inc. | 2009-05-21 |
| TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S008) | Boston Scientific Corp | 2009-05-21 |
| ZENITH TX2 TAA ENDOVASCULAR GRAFT (P070016/S004) | William Cook Europe Aps | 2009-05-21 |
| DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR (P820003/S091) | Medtronic Cardiac Rhythm Disease Management | 2009-05-21 |
| CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS (P010031/S147) | Medtronic Cardiac Rhythm Disease Management | 2009-05-21 |
| DEFLUX INJECTABLE GEL (P000029/S050) | Palette Life Sciences | 2009-05-21 |
| RENEWAL/LIVIAN FAMILIES (P010012/S208) | Boston Scientific Corp | 2009-05-21 |
| KAPPA 600/700/650&800/900 & SIGMA/MEDTRONIC 350/RELIA/ENPULSE II/AT500/ADAPTA/VERSA/SENSIA/ENRHYTHM FAMILIES OF IPG (P980035/S131) | Medtronic, Inc. | 2009-05-21 |
| DEMA FAMILIES/C & T SERIES DEVICES (P990001/S052) | Medtronic, Inc. | 2009-05-21 |
| TRANSVENE CS/SVC LEAD (P980050/S041) | Medtronic, Inc. | 2009-05-21 |
| VARIOUS FAMILIES OF PACEMAKERS (P850051/S070) | Medtronic, Inc. | 2009-05-21 |
| INSYNC III (P010015/S065) | Medtronic, Inc. | 2009-05-21 |
| 30 CM SPECIFY 5-6-5 LEAD (P840001/S134) | Medtronic Neuromodulation | 2009-05-20 |
| HEMA FOR VISTAKON (ETAFILCON A) SOFT HYDROPHILIC CONTACT LENSES (N18033/S041) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2009-05-20 |
| APLIGRAF (P950032/S051) | Organogenesis, Inc. | 2009-05-19 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S005) | Srs Medical | 2009-05-19 |
| LCS TOTAL KNEE SYSTEM (P830055/S109) | Depuy, Inc. | 2009-05-18 |
| PROLIEVE THERMODILITATION SYSTEM (P030006/S017) | Medifocus, Inc. | 2009-05-18 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S022) | Boston Scientific Scimed, Inc. | 2009-05-15 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S036) | Boston Scientific Scimed, Inc. | 2009-05-15 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S044) | Boston Scientific Corp | 2009-05-15 |
| SYNCHROMED II IMPLANTABLE INFUSION PUMPS (P860004/S105) | Medtronic, Inc. | 2009-05-14 |
| VARIOUS FAMILIES OF PACEMAKERS/ DEFIBRILLATORS/ CRTS (P920015/S054) | Medtronic, Inc. | 2009-05-14 |
| HTA SYSTEM (P000040/S013) | Axora Medical, Inc. | 2009-05-14 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S032) | Medtronic Sofamor Danek USA, Inc. | 2009-05-13 |
| CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS (P950005/S026) | Biosense Webster, Inc. | 2009-05-13 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000054/S021) | Medtronic Sofamor Danek USA, Inc. | 2009-05-13 |
| VISTAKON (SENOFILCON A) CONTACT LENSES FOR EXTENDED WEAR (P040045/S004) | Vistakon, Division of Johnson & Johnson Vision Car | 2009-05-13 |
| CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS (P990025/S018) | Biosense Webster, Inc. | 2009-05-13 |
| CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS (P010068/S014) | Biosense Webster, Inc. | 2009-05-13 |
| APEX PTCA BALLOON DILATION CATHETER (P860019/S235) | Scimed Life Systems, Inc. | 2009-05-13 |
| LUMAX FAMILY OF ICDS (P050023/S020) | Biotronik, Inc. | 2009-05-12 |
| LUMOS DR-T AND LUMOS VR-T (P000009/S033) | Biotronik, Inc. | 2009-05-12 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S031) | ABBOTT MEDICAL | 2009-05-12 |
| BRYAN CERVICAL DISC PROSTHESIS (P060023) | Companion Spine France Sas | 2009-05-12 |
| PHILOS II DR-T (P950037/S068) | Biotronik, Inc. | 2009-05-12 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S014) | Cordis US Corporation | 2009-05-12 |
| STRATOS LV-T (P070008/S009) | Biotronik, Inc. | 2009-05-12 |
| ATS MEDICAL OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE (P990046/S021) | Medtronic Ats Medical, Inc. | 2009-05-12 |
| ATTAIN ABILITY LEAD (P080006/S001) | Medtronic, Inc. | 2009-05-08 |
| STELKAST SURPASS ACETABULAR SYSTEM (P040051/S001) | Stelkast Company | 2009-05-08 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S023) | Hologic, Inc. | 2009-05-08 |
| APEX MONORAIL & OVER-THE-WIRE PTCA CATHETERS (P860019/S236) | Scimed Life Systems, Inc. | 2009-05-08 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S012) | Abbott Laboratories | 2009-05-08 |
| XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S015) | Abbott Vascular, Inc. | 2009-05-08 |
| NEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE (P060037/S008) | Zimmer, Inc. | 2009-05-08 |
| OVATIO VR/DR (P980049/S048) | MicroPort CRM USA, Inc. | 2009-05-08 |
| CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II (P010031/S154) | Medtronic Cardiac Rhythm Disease Management | 2009-05-08 |