| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD (P850089/S114) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S222) | Boston Scientific Corp | 2015-05-04 |
| CONSULTA CRT-D,MAXIMO II CRT-D, CONCERTO II CRT-D,CONCERTO CRT-D, PROTECTA AND PROTECTA XT,VIVA XT,VIVA S,BRAVA CRT-DS (P010031/S499) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| SPRINT QUATTRO LEAD (P920015/S153) | Medtronic, Inc. | 2015-05-04 |
| TACTICATH QUARTZ SET (P130026/S004) | St Jude Medical | 2015-05-02 |
| ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM (P030008/S017) | Alcon Laboratories, Inc. | 2015-05-01 |
| TECNIS ACRYLIC INTRAOCULAR LENS (P990080/S039) | Johnson & Johnson Surgical Vision, Inc. | 2015-05-01 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 (P060030/S045) | Roche Molecular Systems, Inc. | 2015-05-01 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S076) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2015-05-01 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S050) | Vistakon, Division of Johnson & Johnson Vision Car | 2015-05-01 |
| 600C ASPHERIC INTRAOCULAR LENS (P060011/S005) | Rayner Intraocular Lenses , Ltd. | 2015-05-01 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S019) | Roche Molecular Systems, Inc. | 2015-05-01 |
| COBAS HPV TEST (P100020/S013) | Roche Molecular Systems, Inc. | 2015-05-01 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S044) | Roche Molecular Systems, Inc. | 2015-05-01 |
| SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (P980040/S061) | Johnson & Johnson Surgical Vision, Inc. | 2015-05-01 |
| ALLEGRO TOPOLYZER VARIO (P020050/S019) | Alcon Laboratories, Inc. | 2015-05-01 |
| TECNIS CL FOLDABLE SILICONE INTRAOCULAR LENS (P880081/S039) | Johnson & Johnson Surgical Vision, Inc. | 2015-05-01 |
| MYOPORE SUTURELESS MYOCARDIAL PACING LEAD (P130012) | Great Batch Medical | 2015-04-30 |
| GORE CARDIOFORM SEPTAL OCCLUDER (P050006/S044) | W. L. Gore & Associates, Inc. | 2015-04-30 |
| TACTICATH QUARTZ SET (P130026/S003) | St Jude Medical | 2015-04-30 |
| ACRYSOF(R) IQ TORIC INTRAOCULAR LENS (P930014/S074) | Alcon Laboratories, Inc. | 2015-04-30 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM (P110023/S012) | Medtronic Vascular, Inc. | 2015-04-29 |
| ENVISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (IOL) (P910056/S020) | Bausch & Lomb, Inc. | 2015-04-29 |
| COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S049) | Integra Lifesciences Corp. | 2015-04-29 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S020) | LeMaitre Vascular, Inc. | 2015-04-29 |
| LCS TOTAL KNEE SYSTEM (P830055/S158) | Depuy, Inc. | 2015-04-29 |
| RADIESSE DERMAL FILLER (P050037/S057) | Merz North America, Inc. | 2015-04-29 |
| ATTAIN PERFORMA (P080006/S080) | Medtronic, Inc. | 2015-04-29 |
| MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS (P990075/S032) | Mentor Worldwide, LLC | 2015-04-29 |
| COAPTITE INJECTABLE IMPLANT (P040047/S039) | Merz North America, Inc. | 2015-04-29 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S064) | Integra LifeSciences Corporation | 2015-04-29 |
| MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S027) | Mentor Corp. | 2015-04-29 |
| RADIESSE & RADIESSE (+) DERMAL FILLER (P050052/S063) | Merz North America, Inc. | 2015-04-29 |
| MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S010) | Mentor Worldwide, LLC | 2015-04-29 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT- MICROFIBRILLAR FORM (P810006/S065) | Integra LifeSciences Corporation | 2015-04-29 |
| BOLOTERO BALANCE INJECTABLE DERMAL FILLER (P090016/S015) | Merz North America, Inc. | 2015-04-29 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S221) | Boston Scientific Corp | 2015-04-29 |
| ATTAIN PERFORMA (P080006/S078) | Medtronic, Inc. | 2015-04-28 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S213) | Boston Scientific Corp | 2015-04-28 |
| MODEL 5071 LEAD (P120017) | Medtronic, Inc. | 2015-04-27 |
| QIAGEN THERASCREEN KRAS RGQ PCR KIT (P110027/S007) | QIAGEN GmbH | 2015-04-24 |
| INFUSE BONE GRAFT (P000054/S043) | Medtronic Sofamor Danek USA, Inc. | 2015-04-24 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (P040044/S063) | Cordis US Corporation | 2015-04-24 |
| INFUSE BONE GRAFT (P050053/S034) | Medtronic, Inc. | 2015-04-24 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S005) | Reshape Lifesciences, Inc. | 2015-04-24 |
| INFUSE BONE GRAFT LUMBAR TAPERED FUSION DEVICE (P000058/S057) | Medtronic Sofamor Danek USA, Inc. | 2015-04-24 |
| QIAGEN THERASCREEN EGFR RGQ PCR KIT (P120022/S009) | QIAGEN GmbH | 2015-04-24 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S023) | Corcym Canada Corp | 2015-04-23 |
| REALTIME HCV GENOTYPE II (P120012/S007) | Abbott Molecular | 2015-04-23 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S112) | W. L. Gore & Associates, Inc. | 2015-04-23 |
| QIAGEN THERASCREEN KRAS RGQ PCR KIT (P110027/S006) | QIAGEN GmbH | 2015-04-23 |
| ABBOTT REALTIME HBV ASSAY (P080026/S014) | Abbott Molecular, Inc. | 2015-04-23 |
| BLAZER II/ II HTD, BLAZER PRIME HTD SYSTEM CABLES (P920047/S078) | Boston Scientific Corp | 2015-04-23 |
| BLAZER II XP, BLAZER PRIME XP, INTELLATIP MIFI XP SYSTEM CABLES (P020025/S069) | Boston Scientific | 2015-04-23 |
| LIFESTENT VASCULAR STENT SYSTEM (P070014/S047) | Bard Peripheral Vascular, Inc. | 2015-04-23 |
| ABBOTT REALTIME HCV ASSAY (P100017/S012) | Abbott Molecular, Inc. | 2015-04-23 |
| CHILLI II COOLED CATHETER ABLATION SYSTEM (P980003/S058) | Boston Scientific Corp | 2015-04-23 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BI (P860057/S136) | Edwards Lifesciences, LLC | 2015-04-23 |
| QIAGEN THERASCREEN EGFR RGQ PCR KIT (P120022/S008) | QIAGEN GmbH | 2015-04-23 |
| LUTONIX DRUG COATED BALLOON (DCB) (P130024/S004) | Lutonix | 2015-04-23 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S064) | Integra LifeSciences Corporation | 2015-04-22 |
| VIDAS TOTAL PSA (P040008/S011) | bioMerieux, Inc. | 2015-04-22 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S004) | Reshape Lifesciences, Inc. | 2015-04-22 |
| PROTEGE MRI NEUROSTIMULATION SYSTEM (P010032/S085) | ABBOTT MEDICAL | 2015-04-22 |
| COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY (P840062/S048) | Integra Lifesciences Corp. | 2015-04-22 |
| DEMIPULSE MODEL 103 GENERATOR (P970003/S178) | LivaNova USA, Inc. | 2015-04-22 |
| EXOGEN ULTRASOUND BONE HEALING SYSTEM (P900009/S039) | Bioventus, LLC | 2015-04-22 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S003) | Reshape Lifesciences, Inc. | 2015-04-22 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S046) | Integra Lifesciences Corp. | 2015-04-22 |
| MODEL 3024 INSPIRE II IMPLANTABLE PULSE GENERATOR (IPG) (P130008/S007) | Inspire Medical Systems | 2015-04-22 |
| RESTORE,ITREL, SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,RESUME,SPECIFY, VECTRIS SPINAL CORD STIMULAION LEADS (P840001/S299) | Medtronic Neuromodulation | 2015-04-22 |
| PERFLUORON (P950018/S018) | Alcon Laboratories | 2015-04-22 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S063) | Integra LifeSciences Corporation | 2015-04-22 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S012) | Torax Medical | 2015-04-21 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S127) | Medtronic, Inc. | 2015-04-21 |
| ADVISA SR MRI (P980035/S418) | Medtronic, Inc. | 2015-04-21 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011) | Siemens Medical Solutions USA, Inc. | 2015-04-21 |
| ADVISA SR MRI (P980035/S419) | Medtronic, Inc. | 2015-04-21 |
| CAPSUREFIX MRI LEAD (P090013/S182) | Medtronic, Inc. | 2015-04-21 |
| REVO MRI SURESCAN IPG (P090013/S183) | Medtronic, Inc. | 2015-04-21 |
| ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER,ETHICON ENDO-SURGERY GASTRIC BAND (P070009/S015) | Obtech Medical GmbH | 2015-04-20 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S224) | Medtronic, Inc. | 2015-04-17 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S040) | Allergan | 2015-04-17 |
| INTERSTIM THERAPY SYSTEM (P970004/S196) | Medtronic Neuromodulation | 2015-04-17 |
| TECNIS 1- PIECE IOL WITH TECNIS ITEC, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC, AND TECNIS TORIC 1-PIECE IOL (P980040/S060) | Johnson & Johnson Surgical Vision, Inc. | 2015-04-17 |
| SYNCHROMED INFUSION SYSTEM (P860004/S226) | Medtronic, Inc. | 2015-04-17 |
| PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILY OF CRT-D DEVICES (P030054/S285) | ABBOTT MEDICAL | 2015-04-17 |
| RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCE, SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S298) | Medtronic Neuromodulation | 2015-04-17 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S006) | Reshape Lifesciences, Inc. | 2015-04-17 |
| CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES (P910023/S356) | ABBOTT MEDICAL | 2015-04-17 |
| TECNIS TORIC 1-PIECE IOL, MODEL ZCT375 (P980040/S057) | Johnson & Johnson Surgical Vision, Inc. | 2015-04-17 |
| KAMRA INLAY (P120023) | Corneagen | 2015-04-17 |
| INTERSTIM THERAPY SYSTEM (P080025/S091) | Medtronic Neuromodulation | 2015-04-17 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT- MICROFIBRILLAR FORM (P810006/S063) | Integra LifeSciences Corporation | 2015-04-16 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S034) | Dexcom, Inc. | 2015-04-16 |
| COLLACOTE, COLLATAPE, COLLAPLUG, ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY (P840062/S047) | Integra Lifesciences Corp. | 2015-04-16 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S031) | Edwards Lifesciences, LLC | 2015-04-16 |
| CORDIS SMART CONTROL NITINOL STENT SYSTEMS (P020036/S032) | Cordis US Corporation | 2015-04-16 |
| CORDIS PALMAZ BALLOON-EXPANDABLE STENT (P890017/S016) | Cordis US Corporation | 2015-04-16 |
| PARADIGM REAL-TIME INSULIN PUMPS, PARADIGM REAL-TIME REVEL INSULIN PUMPS (P980022/S180) | Medtronic Minimed | 2015-04-16 |