| CONCEPTUS ESSURE SYSTEM (P020014/S033) | Bayer Pharma AG | 2012-02-22 |
| CARDIOGENESIS HOLMIUM TMR SYSTEM (P970029/S014) | Cryolife, Inc. | 2012-02-22 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028) | Abbott Vascular, Inc. | 2012-02-22 |
| LCS TOTAL KNEE SYSTEM (P830055/S125) | Depuy, Inc. | 2012-02-21 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S044) | Abbott Vascular | 2012-02-21 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S010) | Abbott Vascular | 2012-02-21 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM (P970038/S015) | Beckman Coulter, Inc. | 2012-02-17 |
| INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR/INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR (P860004/S167) | Medtronic, Inc. | 2012-02-17 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM (P850048/S026) | Beckman Coulter, Inc. | 2012-02-17 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S032) | Spectranetics (Philips) | 2012-02-17 |
| SEPRAFILM (P950034/S040) | Baxter Healthcare Corporation | 2012-02-17 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S126) | Boston Scientific Corp | 2012-02-17 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S051) | Spectranetics Corp. | 2012-02-17 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S127) | Boston Scientific Corp | 2012-02-17 |
| RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013) | Medtronic Vascular | 2012-02-17 |
| ON-X PROSTHETIC HEART VALVE (P000037/S024) | On-X Life Technologies, Inc. | 2012-02-17 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S005) | Edwards Lifesciences, LLC | 2012-02-17 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S016) | Beckman Coulter, Inc. | 2012-02-17 |
| SYNCHROMED II INFUSION PUMP (P860004/S161) | Medtronic, Inc. | 2012-02-16 |
| REPLY/ESPRIT (P950029/S066) | MicroPort CRM USA, Inc. | 2012-02-16 |
| CONTAK RENEWAL TR (P030005/S081) | Guidant Corp. | 2012-02-16 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S057) | Alcon Laboratories, Inc. | 2012-02-16 |
| ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S039) | Alcon Research, Ltd. | 2012-02-16 |
| PARADYM VR & DR (P980049/S070) | MicroPort CRM USA, Inc. | 2012-02-16 |
| PARADYM CRT-D (P060027/S037) | MicroPort CRM USA, Inc. | 2012-02-16 |
| CONTAK RENEWAL TR, CONTAK RENEWAL 3, LEVIAN SE/HE, COGNIS, INCEPTA (P010012/S280) | Boston Scientific Corp | 2012-02-16 |
| STELID II BFT/BJF/STELIX BR/STELIX II BRF (P020030/S009) | MicroPort CRM USA, Inc. | 2012-02-16 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S084) | Boston Scientific Corp | 2012-02-15 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S002) | Ventana Medical Systems, Inc. | 2012-02-15 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S034) | Boston Scientific Corp | 2012-02-15 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON 5 PRODUCTS (P810031/S043) | Johnson & Johnson Surgical Vision, Inc. | 2012-02-15 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S070) | Terumo Medical Corporation | 2012-02-15 |
| CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP (P980003/S034) | Boston Scientific Corp | 2012-02-15 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S036) | Endologix, LLC | 2012-02-15 |
| TRANSCEND HIP ARTICULATION SYSTEM (P010001/S010) | Ceramtec GmbH | 2012-02-14 |
| GENESYS HTA SYSTEM (P000040/S022) | Axora Medical, Inc. | 2012-02-14 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S024) | Coloplast Corp. | 2012-02-13 |
| PROGENSA PCA3 ASSAY (P100033) | Gen-Probe Incorporated | 2012-02-13 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S039) | Cordis US Corporation | 2012-02-13 |
| IMMUNOASAY, PSA (P910065/S008) | Tosoh Bioscience, Inc. | 2012-02-13 |
| NEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE (P060037/S016) | Zimmer, Inc. | 2012-02-10 |
| BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES (P780007/S047) | CooperVision, Inc. | 2012-02-10 |
| BREAST COMPANION SOFTWARE SYSTEM (P100007) | Almen Laboratories, Inc. | 2012-02-10 |
| TRILOGY AB ACETABULAR SYSTEM (P040048/S016) | Zimmer, Inc. | 2012-02-10 |
| MODEL 3058 INTERSTIM II NEUROSTIMULATOR (P080025/S022) | Medtronic Neuromodulation | 2012-02-10 |
| LCS TOTAL KNEE SYSTEM (P830055/S121) | Depuy, Inc. | 2012-02-09 |
| BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES (P780007/S048) | CooperVision, Inc. | 2012-02-09 |
| BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES (P780007/S049) | CooperVision, Inc. | 2012-02-09 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S014) | Medtronic Cryocath, LP | 2012-02-09 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S031) | Vistakon, Division of Johnson & Johnson Vision Car | 2012-02-09 |
| ARTEFILL® - PMMA COLLAGEN DERMAL FILLER (P020012/S006) | Tiger Aesthetics Medical, LLC | 2012-02-09 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S026) | Hologic, Inc. | 2012-02-09 |
| VIDAS TOTAL PSA (TPSA) (P040008/S002) | bioMerieux, Inc. | 2012-02-08 |
| VIDAS FREE PSA (FPSA) ASSAY (P080008/S001) | bioMerieux, Inc. | 2012-02-08 |
| CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE 4MM TIP CATHETERS/CELSIUS RMT DIAGNOSTIC/ABLATION STEERABLE TIP (P950005/S033) | Biosense Webster, Inc. | 2012-02-08 |
| NAVISTAR, CELSIUS, QWIKSTAR, EZ STEER BI-DIRECTIONAL, NAVISTAR RMT DUAL SENOR (8MM) DIAGNOSTIC/ABLATION DEFLECTABLE (P010068/S023) | Biosense Webster, Inc. | 2012-02-08 |
| FRESHLOOK UV (PHEMFILCON A) SPHERICAL SOFT CONTACT LENSES FOR EXTENDED WEAR (P830037/S053) | Alcon Laboratories, Inc. | 2012-02-07 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012) | Infusyn Therapeutics, LLC | 2012-02-07 |
| S.M.A.R.T. NITINOL STENT SYSTEM & S.M.A.R.T. CONTROL NITINOL STENT SYSTEM FOR USE IN LLIAC ARTERIES (P020036/S022) | Cordis US Corporation | 2012-02-06 |
| CARELINK IPRO THERAPY MANAGEMENT SOFTWARE (MODEL, MMT-7340) (P980022/S107) | Medtronic Minimed | 2012-02-06 |
| TRIFECA VALVE (P100029/S010) | ABBOTT MEDICAL | 2012-02-06 |
| GORE VIABAHN ENDOPROSTHESIS & ENDOPROSTHESIS WITH HERPARIN BIOACTIVE SURFACE (P040037/S041) | W. L. Gore & Associates, Inc. | 2012-02-06 |
| GORE VIABAHN ENDOPROSTHESIS & ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S040) | W. L. Gore & Associates, Inc. | 2012-02-06 |
| PRECISE OTW/PRECISE RX & PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S023) | Cordis US Corporation | 2012-02-06 |
| LCS TOTAL KNEE SYSTEM (P830055/S122) | Depuy, Inc. | 2012-02-06 |
| VNS THERAPY SYSTEM (P970003/S145) | LivaNova USA, Inc. | 2012-02-06 |
| DEEP BRAIN STIMULATION (DBS) EXTENSION KITS (P960009/S134) | Medtronic, Inc. | 2012-02-03 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S033) | Biomet Manufacturing Corp | 2012-02-03 |
| OCUCOAT SYRINGE PRODUCT (P860047/S025) | Bausch & Lomb, Inc. | 2012-02-03 |
| ETHICON OMNEX SURGICAL SEALANT (P060029/S003) | ETHICON, Inc. | 2012-02-03 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON5 (P810031/S042) | Johnson & Johnson Surgical Vision, Inc. | 2012-02-03 |
| DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) (P840064/S048) | Alcon Laboratories | 2012-02-03 |
| PROVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) (P890047/S036) | Alcon Research, Ltd. | 2012-02-03 |
| ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S008) | Siemens Healthcare Diagnostics | 2012-02-03 |
| UROLOGIX TARGIS SYSTEM (P970008/S060) | Urologix, LLC | 2012-02-03 |
| ARTISAN-VERISYSE MYOPIA PHAKIC IOL (P030028/S003) | Ophtec BV | 2012-02-03 |
| REPLY/ESPRIT (P950029/S065) | MicroPort CRM USA, Inc. | 2012-02-02 |
| PARADYM VR & DR (P980049/S069) | MicroPort CRM USA, Inc. | 2012-02-02 |
| ANTHEM CRT-P DEVICES (P030035/S093) | ABBOTT MEDICAL | 2012-02-02 |
| PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (P950042/S007) | Novadaq Technologies, Inc. | 2012-02-02 |
| PARADYM CRT-D (P060027/S036) | MicroPort CRM USA, Inc. | 2012-02-02 |
| ACCENT PACEMAKER DEVICES (P880086/S215) | ABBOTT MEDICAL | 2012-02-02 |
| DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) & DUOVISC VISCOELASTIC SYSTEM (P840064/S049) | Alcon Laboratories | 2012-02-01 |
| VNS THERAPY SYSTEM (P970003/S144) | LivaNova USA, Inc. | 2012-02-01 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S124) | Boston Scientific Corp | 2012-02-01 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P890047/S037) | Alcon Research, Ltd. | 2012-02-01 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S061) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2012-02-01 |
| HER2 CISH PHARMADX KIT (P100024/S001) | Dako Denmark A/S | 2012-02-01 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S026) | Vistakon, Division of Johnson & Johnson Vision Car | 2012-02-01 |
| HIGH FREQUENCY OSCILLATING VENTILATOR (P890057/S020) | ZOLL Medical Corporation | 2012-01-31 |
| TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM (P000023/S006) | Nexus CMF, LLC | 2012-01-31 |
| INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P970004/S129) | Medtronic Neuromodulation | 2012-01-31 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S001) | Edwards Lifesciences, LLC | 2012-01-31 |
| TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM (P000035/S006) | Nexus CMF, LLC | 2012-01-31 |
| CELLPAKER PLASMA COLLECTION DEVICE (P050044/S019) | Stryker Corp. | 2012-01-31 |
| INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025/S026) | Medtronic Neuromodulation | 2012-01-30 |
| CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S008) | Boston Scientific Corp | 2012-01-27 |
| BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID) (P960011/S020) | Altacor , Ltd. | 2012-01-27 |
| EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S013) | Ferring Pharmaceuticals, Inc. | 2012-01-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082) | Cordis Corp. | 2012-01-27 |