| PHILOS II FAMILY OF PULSE GENERATORS (P950037/S065) | Biotronik, Inc. | 2008-11-06 |
| LPS-FLEX MOBILE (P060037/S004) | Zimmer, Inc. | 2008-11-06 |
| OVATIO VR & DR ICDS (P980049/S036) | MicroPort CRM USA, Inc. | 2008-11-06 |
| COROX OTW (-S) BP LEFT VENTRICULAR LEADS (P070008/S005) | Biotronik, Inc. | 2008-11-06 |
| RESTOREULTRA IMPLANTABLE NEUROSTIMULATOR (P840001/S121) | Medtronic Neuromodulation | 2008-11-06 |
| INSYNC FAMILIES OF ICD & CONCERTO ICD (P010031/S128) | Medtronic Cardiac Rhythm Disease Management | 2008-11-05 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S086) | Boston Scientific Corp | 2008-11-05 |
| N¿VISION PROGRAMMING SYSTEM (P960009/S041) | Medtronic, Inc. | 2008-11-05 |
| MAXIMO/MARQUIS/INTRINSIC 30/INTRINSIC/ENTRUST (P980016/S160) | Medtronic Cardiac Rhythm Disease Management | 2008-11-05 |
| SYNCHROMED II INFUSION SYSTEM (P860004/S089) | Medtronic, Inc. | 2008-11-05 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S002) | Medtronic Vascular | 2008-11-05 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S035) | W. L. Gore & Associates, Inc. | 2008-11-05 |
| ADAPTA/SENSIA/ VERSA FAMILY OF IMPLANTABLE PULSE GENERATORS (IPGS) (P980035/S095) | Medtronic, Inc. | 2008-11-05 |
| N¿VISION PROGRAMMING SYSTEM (P840001/S098) | Medtronic Neuromodulation | 2008-11-05 |
| ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S065) | ABBOTT MEDICAL | 2008-11-05 |
| LUMOS ICDS/XELOS DR-T ICD/LEXOS ICDS (P000009/S026) | Biotronik, Inc. | 2008-11-04 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEM (P030009/S025) | Medtronic, Ireland | 2008-11-04 |
| KRONOS LV-T CRT-D (P050023/S011) | Biotronik, Inc. | 2008-11-04 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S008) | Allergan | 2008-11-04 |
| ENDOLOGIX, INC. POWERLINK SYSTEM (P040002/S019) | Endologix, LLC | 2008-11-04 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S010) | Medtronic, Inc. | 2008-11-04 |
| EXPRESS MR & OTW CORONARY STENT SYSTEM (P020009/S047) | Boston Scientific Scimed, Inc. | 2008-11-04 |
| CORMET HIP RESUFACING SYSTEM (P050016/S004) | Corin USA | 2008-11-04 |
| ACTROS, AXIOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, AND PROTOS FAMILIES OF PULSE GENERATORS (P950037/S059) | Biotronik, Inc. | 2008-11-04 |
| CARDIAC AIRBAG AND BELOS FAMILIES OF ICDS (P980023/S031) | Biotronik, Inc. | 2008-11-04 |
| PTCA CATHETERS (P860019/S229) | Scimed Life Systems, Inc. | 2008-11-04 |
| STRATOS LV/LV-T (P070008/S001) | Biotronik, Inc. | 2008-11-04 |
| BAUSCH & LOMB PUREVISION (BALAFILCON) VISIBILITY TINTED CONTACT LENSES (P980006/S013) | Bausch & Lomb, Inc. | 2008-11-03 |
| BAUSCH & LOMB SOFLENS 66 AND SOFLENS TORIC (ALPHAFILCON) SOFT CONTACT LENS (P960022/S005) | Bausch & Lomb, Inc. | 2008-11-03 |
| BAUSCH & LOMB SOFTLENS (POLYMACON) CONTACT LENS (N16895/S090) | Bausch & Lomb, Inc. | 2008-11-03 |
| OVATIO CRT-D SYSTEM (P060027/S002) | MicroPort CRM USA, Inc. | 2008-10-31 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S070) | Advanced Bionics | 2008-10-31 |
| OVATIO VR 6250 AND OVATIO DR 6550 (P980049/S040) | MicroPort CRM USA, Inc. | 2008-10-31 |
| EVOLENCE COLLAGEN FILLER (P070013/S005) | Colbar Lifescience , Ltd. | 2008-10-31 |
| THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (P870072/S040) | Thoratec Laboratories Corp. | 2008-10-31 |
| OVATIO CRT 6750 (P060027/S004) | MicroPort CRM USA, Inc. | 2008-10-31 |
| RELIANCE FAMILY OF LEADS (P910073/S073) | Boston Scientific | 2008-10-31 |
| VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER (P990048/S003) | Carl Zeiss Meditec, AG | 2008-10-31 |
| QUANTIFERON - TB GOLD-IN-TUBE (P010033/S013) | Qiagen | 2008-10-31 |
| SPRINTER LEGEND RX BALLOON DILATATION CATHETER (P790017/S096) | Medtronic, Ireland | 2008-10-31 |
| ELECSYS HBSAG TEST SYSTEM (P990012/S006) | Roche Diagnostics Corp. | 2008-10-30 |
| PRECISE NITINOL STENT SYSTEM (P030047/S015) | Cordis US Corporation | 2008-10-30 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030) | Roche Molecular Systems, Inc. | 2008-10-30 |
| ELECSYS ANTI-HBS TEST SYSTEM (P010054/S008) | Roche Diagnostics Corp. | 2008-10-30 |
| SMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM (P020036/S011) | Cordis US Corporation | 2008-10-30 |
| ATS 3F AORTIC BIOPROSTHESIS (P060025) | Medtronic, Inc. | 2008-10-30 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S029) | Edwards Lifesciences, LLC | 2008-10-29 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S017) | Edwards Lifesciences, LLC | 2008-10-29 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S089) | Boston Scientific Corp | 2008-10-29 |
| CARPENTIER-EDWARDS VALVED CONDUIT BIOPROSTHESIS (P870056/S030) | Edwards Lifesciences, LLC | 2008-10-29 |
| RESTYLANE INJECTABLE GEL (P040024/S029) | Q-Med AB | 2008-10-29 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S050) | Edwards Lifesciences, LLC | 2008-10-29 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S018) | Edwards Lifesciences, LLC | 2008-10-29 |
| VNS THERAPY SYSTEM (P970003/S101) | LivaNova USA, Inc. | 2008-10-28 |
| FLAIR ENDOVASCULAR STENT GRAFT WITH OPTIMIZED DELIVERY SYSTEM (P060002/S002) | Bard Peripheral Vascular | 2008-10-28 |
| EASYTRAK 3 (P910073/S074) | Boston Scientific | 2008-10-24 |
| MARQUIS DR/VR 7274/7230 ICD (P980016/S150) | Medtronic Cardiac Rhythm Disease Management | 2008-10-24 |
| FLOSEAL ENDOSCOPIC APPLICATOR (P990009/S024) | Baxter Healthcare Corp | 2008-10-24 |
| VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM (P990052/S021) | Med-El Elektromedizinische Gerate GmbH | 2008-10-24 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S038) | Med-El Corp. | 2008-10-24 |
| NATRELLE SALINE-FILLED BREAST IMPLANTS (P990074/S020) | Allergan | 2008-10-24 |
| VIRTUOSO II ICD DR/VR (P980016/S157) | Medtronic Cardiac Rhythm Disease Management | 2008-10-23 |
| CONCENTRO II CRT-D (P010031/S125) | Medtronic Cardiac Rhythm Disease Management | 2008-10-23 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019) | Boston Scientific Corp | 2008-10-23 |
| DEFLUX INJECTABLE GEL (P000029/S051) | Palette Life Sciences | 2008-10-22 |
| MICRO-DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM (P030009/S020) | Medtronic, Ireland | 2008-10-22 |
| RESTYLANE INJECTABLE GEL (P040024/S028) | Q-Med AB | 2008-10-22 |
| RAPID FFN FOR THE TLIIQ SYSTEM (P920048/S006) | Hologic, Inc. | 2008-10-22 |
| VIRTUOSO II ICD DR/VR MODELS (P980016/S158) | Medtronic Cardiac Rhythm Disease Management | 2008-10-21 |
| CONCERTO II CRT-D MODELS C154DWK, C164AWK (P010031/S126) | Medtronic Cardiac Rhythm Disease Management | 2008-10-21 |
| SELECTSECURE 3830 (P030036/S003) | Medtronic Cardiac Rhythm Disease Management | 2008-10-21 |
| CARELINK MONITOR MODEL 2490C, MODEL 2491 DDMA AND CARDIOSIGHT READER MODEL 2020A (P890003/S150) | Medtronic, Inc. | 2008-10-21 |
| INSYNC & INSYNC III (P010015/S053) | Medtronic, Inc. | 2008-10-17 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S116) | Medtronic, Inc. | 2008-10-17 |
| SYNCHROMED PUMP & INFUSION SYSTEM (P860004/S099) | Medtronic, Inc. | 2008-10-17 |
| ACTIVA THERAPY FOR DBS (P960009/S055) | Medtronic, Inc. | 2008-10-17 |
| CLARITY, DIAMOND 3, JADE 3, RUBY 3, TOPAZ 3, VITA 2 DDR, C-SERIES, AND T-SERIES (P990001/S045) | Medtronic, Inc. | 2008-10-17 |
| SECURA ICD (P980016/S156) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| STELID II, STELIX, AND STLIX II STEROID-ELUTING PACING LEADS (P020030/S004) | MicroPort CRM USA, Inc. | 2008-10-17 |
| VARIOUS FAMILIES OF CRT-ICDS (P010031/S122) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| MEDTRONIC MODEL 5388 & 5348 EXTERNAL PULSE GENERATOR (P820003/S085) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| CONCERTO/CONSULTA/MAXIMO II (P010031/S123) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| ELECSYS TOTAL PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER (P990056/S008) | Roche Diagnostics Corp. | 2008-10-17 |
| VARIOUS FAMILIES OF ICDS (P980016/S154) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| ENRHYTHM IPG& ADAPTA/VERSA/SENSIA FAMILY (P980035/S117) | Medtronic, Inc. | 2008-10-17 |
| INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM (P970004/S060) | Medtronic Neuromodulation | 2008-10-17 |
| ENDOTAK RELIANCE (P910073/S076) | Boston Scientific | 2008-10-17 |
| OVATIO VR/DR (P980049/S042) | MicroPort CRM USA, Inc. | 2008-10-17 |
| CONSULTA CRT-D & MAXIMO II CRT-D (P010031/S124) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| ENTRUST/VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR FAMILIES OF ICDS (P980016/S155) | Medtronic Cardiac Rhythm Disease Management | 2008-10-17 |
| OVATIO CRT (P060027/S006) | MicroPort CRM USA, Inc. | 2008-10-17 |
| ELECSYS FREE PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER (P000027/S006) | Roche Diagnostics Corp. | 2008-10-17 |
| RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS (P840001/S118) | Medtronic Neuromodulation | 2008-10-17 |
| ISOMED PUMP AND INFUSION SYSTEM (P990034/S011) | Medtronic, Inc. | 2008-10-17 |
| KAPPA 400 DR/SR (P970012/S044) | Medtronic, Inc. | 2008-10-17 |
| SYMPHONY SR/DR & RHAPSODY SR/DR (P950029/S038) | MicroPort CRM USA, Inc. | 2008-10-17 |
| MONOPREP PAP TEST (P040052/S008) | Hologic, Inc. | 2008-10-16 |
| RADIESSE INJECTABLE IMPLANT (P050037/S011) | Merz North America, Inc. | 2008-10-16 |
| RADIESSE INJECTABLE IMPLANT (P050052/S012) | Merz North America, Inc. | 2008-10-16 |
| ANEURX STENT GRAFT SYSTEM (P990020/S033) | Medtronic Vascular | 2008-10-16 |