| MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR/VIRTUOSO/ENTRUST/MARQUIS/MAXIMO/INTRINSIC ICDS (P980016/S276) | Medtronic Cardiac Rhythm Disease Management | 2011-02-17 |
| CONCERTO II/MAXIMO II/CONSULTA/CONCERTO CRT-DS/INSYNC MAXIMO/SENTRY/INSYNC II MARQUIS/INSYNC III MARQUIS ICDS (P010031/S231) | Medtronic Cardiac Rhythm Disease Management | 2011-02-17 |
| VNS THERAPY SYSTEM (P970003/S120) | LivaNova USA, Inc. | 2011-02-17 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S017) | Bard Peripheral Vascular | 2011-02-16 |
| PRODISC -C TOTAL DISC REPLACEMENT (P070001/S009) | Centinel Spine, LLC | 2011-02-16 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S034) | W. L. Gore & Associates, Inc. | 2011-02-16 |
| LAP-BAND (P000008/S017) | Medtimo, Inc. | 2011-02-16 |
| ON-X PROSTHETIC HEART VALVE (P000037/S022) | On-X Life Technologies, Inc. | 2011-02-16 |
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S032) | Gynecare, Inc. | 2011-02-16 |
| PRODISC -L TOTAL DISC REPLACEMENT (P050010/S008) | Centinel Spine, LLC | 2011-02-16 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S010) | Hologic, Inc. | 2011-02-16 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S002) | Medtronic Vascular | 2011-02-15 |
| PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS (P030047/S019) | Cordis US Corporation | 2011-02-14 |
| VISTAKON (ETAFILCONA) CONTACT LENSES, CLEAR & VISIBILITY TINRED WITH UV BLOCKER (N18033/S052) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2011-02-14 |
| SAMERT NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM (P020036/S016) | Cordis US Corporation | 2011-02-14 |
| VISTAKON (ETAFILCONA) CONTACT LENSES, CLEAR & VISIBILITY TINRED WITH UV BLOCKER (N18033/S053) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2011-02-14 |
| APLIGRAF (P950032/S059) | Organogenesis, Inc. | 2011-02-14 |
| RELIANCE 4-SITE (P910073/S092) | Boston Scientific | 2011-02-11 |
| LUMAX 300/340 DR-T/LUMAX 300/400 VR-T/LUMAX 500/540 DR-T/LUMAX 500/540 VR-T/LUMAX 540 VR-T DX (P050023/S041) | Biotronik, Inc. | 2011-02-11 |
| EON IMPLANTED PULSE GENERATOR (IPG) SYSTEM (P010032/S036) | ABBOTT MEDICAL | 2011-02-11 |
| IMPLANTABLE CV DEFIBRILLATOR/PACEMAKER PROGRAMMER/ICD MONITORING SYSTEM (P000009/S043) | Biotronik, Inc. | 2011-02-11 |
| C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009) | Biomet, Inc. | 2011-02-11 |
| HERCEPTEST (P980018/S012) | Agilent Technologies Singapore (International) Pte , Ltd. | 2011-02-11 |
| STRATOS LV/LV-T (P070008/S021) | Biotronik, Inc. | 2011-02-11 |
| SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P080003) | Hologic, Inc. | 2011-02-11 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S013) | Allergan | 2011-02-11 |
| ST. JUDE MEDICAL EPIC HF SYSTEM (P030054/S155) | ABBOTT MEDICAL | 2011-02-11 |
| ESTELLA AND EFFECTA PULSE GENERATORS (P950037/S092) | Biotronik, Inc. | 2011-02-11 |
| VIRTUOSO II/SECURA/MAXIMO II ICDS (P980016/S275) | Medtronic Cardiac Rhythm Disease Management | 2011-02-10 |
| APLIGRAF (P950032/S062) | Organogenesis, Inc. | 2011-02-10 |
| NEOMEND PROGEL PLEURAL AIR LEAK SEALANT (P010047/S008) | Neomend, Inc. | 2011-02-10 |
| DURATA FAMILY OF HIGH VOLTAGE LEADS (P950022/S076) | ABBOTT MEDICAL | 2011-02-10 |
| CONCERTO II/MAXIMO II/CONSULTA CRT-DS (P010031/S230) | Medtronic Cardiac Rhythm Disease Management | 2011-02-10 |
| PARADYM ICDS AND CRT-D DEVICES (P060027/S029) | MicroPort CRM USA, Inc. | 2011-02-10 |
| OVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980049/S062) | MicroPort CRM USA, Inc. | 2011-02-10 |
| BAUSCH & LOMB SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENSES (N16895/S092) | Bausch & Lomb, Inc. | 2011-02-09 |
| SLS II LASER SHEATH (P960042/S025) | Spectranetics (Philips) | 2011-02-09 |
| IN MOTION LUMBAR ARTIFICIAL DISC (P040006/S005) | Depuy Spine, Inc. | 2011-02-08 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013) | Medtronic, Inc. | 2011-02-08 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S001) | Medtronic Vascular | 2011-02-07 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S013) | Beckman Coulter, Inc. | 2011-02-07 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S024) | Beckman Coulter, Inc. | 2011-02-07 |
| ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S072) | ABBOTT MEDICAL | 2011-02-07 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S014) | Beckman Coulter, Inc. | 2011-02-07 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S028) | Medtronic Vascular | 2011-02-07 |
| ANEURX AAADVANTAGE STENT GRAFT SYSTEM (P990020/S044) | Medtronic Vascular | 2011-02-07 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S027) | Medtronic Vascular | 2011-02-07 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S016) | Stryker Corp. | 2011-02-04 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S025) | Beckman Coulter, Inc. | 2011-02-04 |
| MACROPLASTIQUE IMPLANTS (P040050/S007) | Uroplasty, LLC | 2011-02-04 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S004) | Boston Scientific Corp | 2011-02-04 |
| IMPLANTABLE MINIATURE TELESCOPE (P050034/S004) | Samsara Vision, Inc. | 2011-02-04 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S014) | Beckman Coulter, Inc. | 2011-02-04 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S015) | Beckman Coulter, Inc. | 2011-02-04 |
| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S005) | Boston Scientific Corporation | 2011-02-03 |
| TENDRIL LEADS (P960013/S063) | ABBOTT MEDICAL | 2011-02-03 |
| VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR ICDS (P980016/S274) | Medtronic Cardiac Rhythm Disease Management | 2011-02-03 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S009) | Corcym Canada Corp | 2011-02-03 |
| CERVISTA (P080015/S003) | Hologic, Inc. | 2011-02-03 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S046) | Abbott Vascular, Inc. | 2011-02-03 |
| NAVISTAR RMT DS CATHETER (8MM) (P010068/S021) | Biosense Webster, Inc. | 2011-02-03 |
| MULTI-LINK 8TM/MULTI-LINK 8 LLTM/MULTI-LINK 8TM SV CORONARY STENT SYSTEM (P020047/S023) | Abbott Vascular | 2011-02-03 |
| CELSIUS RMT CATHETER (4MM) (P950005/S031) | Biosense Webster, Inc. | 2011-02-03 |
| NAVISTAR RMT CATHETER (4MM) (P990025/S026) | Biosense Webster, Inc. | 2011-02-03 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S043) | Spectranetics Corp. | 2011-02-03 |
| CONSULTA/CONSULTA II/MAXIMO II/CONCERTO CRT-DS (P010031/S229) | Medtronic Cardiac Rhythm Disease Management | 2011-02-03 |
| SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S004) | Lenstec, Inc. | 2011-02-02 |
| FLEX MOBILE BEARING KNEE (P060037/S012) | Zimmer, Inc. | 2011-01-31 |
| MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S092) | Medtronic Minimed | 2011-01-31 |
| SMART & SMART CONTROL NITINOL STENT SYSTEMS (P020036/S020) | Cordis US Corporation | 2011-01-31 |
| PLASMAFLO OP-05W (A) (P820033/S007) | Asahi Kasei Medical Co., Ltd. | 2011-01-28 |
| TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S015) | Cerenovus, Inc. | 2011-01-26 |
| TECHNOLAS 217Z ZYOPTIX SYSTEM (P990027/S016) | Technolas Perfect Vision GmbH | 2011-01-26 |
| INFUSE BONE GRAFT (P050053/S017) | Medtronic, Inc. | 2011-01-26 |
| ACTIVA SC (P960009/S092) | Medtronic, Inc. | 2011-01-26 |
| INFUSE BONE GRAFT (P000054/S026) | Medtronic Sofamor Danek USA, Inc. | 2011-01-26 |
| BLAZER II CARDIAC ABLATION CATHETERS (P920047/S040) | Boston Scientific Corp | 2011-01-26 |
| EXTERNAL NEUROSTIMULATORS (ENS) FLEX CIRCUIT (P840001/S176) | Medtronic Neuromodulation | 2011-01-26 |
| BLAZER II XP CATHETERS (P020025/S021) | Boston Scientific | 2011-01-26 |
| INFUSE BONE GRAFT (P000058/S039) | Medtronic Sofamor Danek USA, Inc. | 2011-01-26 |
| EXTERNAL NEUROSTIMULATORS (ENS) FLEX CIRCUIT (P960009/S107) | Medtronic, Inc. | 2011-01-26 |
| UVAR XTS PROCEDURAL KIT (P860003/S055) | Therakos Development Limited | 2011-01-25 |
| DURATA FAMILY OF LEADS (P950022/S069) | ABBOTT MEDICAL | 2011-01-24 |
| ANIKA VISC (P000046/S019) | Anika Therapeutics, Inc. | 2011-01-24 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S022) | Coloplast Corp. | 2011-01-24 |
| VNS THERAPY SYSTEM (P970003/S119) | LivaNova USA, Inc. | 2011-01-21 |
| CHILLI COOLED ABLATION SYSTEM (P980003/S027) | Boston Scientific Corp | 2011-01-21 |
| POWERLINK STENT GRAFT WITH 17FR. INTUITRAK ACCESSORY DELIVERY SYSTEM (P040002/S029) | Endologix, LLC | 2011-01-20 |
| LUMAX ICDS/CRT-DS (P050023/S043) | Biotronik, Inc. | 2011-01-20 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S071) | Boston Scientific Scimed, Inc. | 2011-01-20 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD (P080006/S019) | Medtronic, Inc. | 2011-01-20 |
| SEPRAFILM (P950034/S039) | Baxter Healthcare Corporation | 2011-01-20 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S112) | Boston Scientific Corp | 2011-01-20 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S115) | Boston Scientific Corp | 2011-01-20 |
| CARPENTIER EDWARDS PROCINE BIOPROSTHESIS (P870056/S042) | Edwards Lifesciences, LLC | 2011-01-20 |
| ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY (P960009/S106) | Medtronic, Inc. | 2011-01-20 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S068) | Boston Scientific Scimed, Inc. | 2011-01-20 |
| DURASEAL DURAL SEALANT SYSTEM (P040034/S019) | Integra LifeSciences Corporation | 2011-01-20 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S065) | Boston Scientific Corp | 2011-01-20 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S008) | Corcym Canada Corp | 2011-01-20 |