| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S041) | ABBOTT MEDICAL | 2008-04-29 |
| SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935 (P920015/S039) | Medtronic, Inc. | 2008-04-29 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S085) | ABBOTT MEDICAL | 2008-04-29 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S162) | ABBOTT MEDICAL | 2008-04-29 |
| ELEVESS (AKA COSMETIC TISSUE AUGMENTATION PRODUCT) (P050033/S002) | Anika Therapeutics, Inc. | 2008-04-29 |
| COAPTITE INJECTABLE IMPLANT (P040047/S004) | Merz North America, Inc. | 2008-04-29 |
| QUANTUM MAVERICK MONORAIL & OTW PTCA CATHETERS (P860019/S223) | Scimed Life Systems, Inc. | 2008-04-28 |
| DEFLUX INJECTABLE GEL (P000029/S043) | Palette Life Sciences | 2008-04-28 |
| ACTIVA THERAPY FOR DBS (P960009/S048) | Medtronic, Inc. | 2008-04-25 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S002) | Srs Medical | 2008-04-25 |
| ITREL & RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS (P840001/S110) | Medtronic Neuromodulation | 2008-04-25 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S004) | Stryker Corp. | 2008-04-25 |
| OVATIO DR & OVATIO VR ICDS (P980049/S034) | MicroPort CRM USA, Inc. | 2008-04-25 |
| INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM (P970004/S053) | Medtronic Neuromodulation | 2008-04-25 |
| STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P990013/S017) | Starr Surgical Co. | 2008-04-24 |
| ASCENSION ORTHOPEDICS MCP (P000057/S004) | Smith & Nephew, Inc. | 2008-04-24 |
| STAAR SURGICAL IMPLANTABLE COLLAMER LENSES (P030016/S005) | STAAR Surgical Company | 2008-04-24 |
| MEDTRONIC INTERSTIM THERAPY (P970004/S049) | Medtronic Neuromodulation | 2008-04-24 |
| QUICKSITE FAMILY OF LEADS-MODELS 1056K, 1056T AND 1058T & QUICKFLEX FAMILY OF LEADS-MODELS 1156T AND 1158T (P030054/S083) | ABBOTT MEDICAL | 2008-04-23 |
| OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S012) | Biomet Manufacturing Corp | 2008-04-23 |
| MINIMED REAL-TIME TRANSMITTER (MMT-7703), CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS) IPRO DIGITAL RECORDER (MMT-7709) (P980022/S026) | Medtronic Minimed | 2008-04-23 |
| ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S004) | Spectranetics Corp. | 2008-04-23 |
| COSEAL SURGICAL SEALANT (P030039/S009) | Baxter Bio Science | 2008-04-23 |
| UROLOGIX TARGIS SYSTEM (P970008/S039) | Urologix, LLC | 2008-04-23 |
| HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S061) | Advanced Bionics | 2008-04-21 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040) | ABBOTT MEDICAL | 2008-04-21 |
| RADIESSE, 1.3 CC AND 0.3 CC (P050052/S004) | Merz North America, Inc. | 2008-04-21 |
| RADIESSE, 1.3 CC AND 0.3 CC (P050037/S003) | Merz North America, Inc. | 2008-04-21 |
| RESTYLANE INJECTABLE GEL (P040024/S012) | Q-Med AB | 2008-04-21 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM & MED EL C40+ COCHLEAR IMPLANT SYSTEM (P000025/S032) | Med-El Corp. | 2008-04-18 |
| PARADIGM REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM (P980022/S021) | Medtronic Minimed | 2008-04-18 |
| ATTAIN LV & CS & OTW & ATTAIN BIPOLAR OTW (P010015/S042) | Medtronic, Inc. | 2008-04-18 |
| GEM DR ICD, GEM II & III FAMILIES, MARQUIS & MAXIMO FAMILES, ONYX, INTRINSIC & ENTRUST & VIRTUOSO FAMILIES OF ICDS (P980016/S125) | Medtronic Cardiac Rhythm Disease Management | 2008-04-18 |
| CAPSURE VDD-2 (P890003/S138) | Medtronic, Inc. | 2008-04-18 |
| MED EL C40+ COCHLEAR IMPLANT SYSTEM (P000025/S031) | Med-El Corp. | 2008-04-18 |
| CAPSURE FIX (P980016/S126) | Medtronic Cardiac Rhythm Disease Management | 2008-04-18 |
| INSYNC & INSYNC III (P010015/S041) | Medtronic, Inc. | 2008-04-18 |
| SELECTSECURE (P030036/S005) | Medtronic Cardiac Rhythm Disease Management | 2008-04-18 |
| CAPSUREFIX, CAPSUREFIX NOVUS, SUREFIX (P930039/S026) | Medtronic, Inc. | 2008-04-18 |
| INTERSTIM II NEUROSTIMULATOR (P970004/S052) | Medtronic Neuromodulation | 2008-04-18 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S050) | Boston Scientific Corp | 2008-04-18 |
| GEM III (P980050/S032) | Medtronic, Inc. | 2008-04-18 |
| EXCELLENCE S+, CAPSURE Z, CAPSURE Z NOVUS, CAPSURE SP NOVUS, CAPSURE SP (P850089/S058) | Medtronic Cardiac Rhythm Disease Management | 2008-04-18 |
| KAPPA 600/700/650/800/900 FAMILIES (P980035/S090) | Medtronic, Inc. | 2008-04-18 |
| CAPSURE, CAPSURE SP, CAPSURE SP NOVUS, CAPSURE SENSE (P830061/S041) | Medtronic Cardiac Rhythm Disease Management | 2008-04-18 |
| PRIME FAMILIES OF IMPLANTABLE NEUROSTIMULATOR (P840001/S109) | Medtronic Neuromodulation | 2008-04-18 |
| INSYNC ICD & INSYNC MARQUIS, INSYNC II & III MARQUIS FAMILY & INSYNC II PROTECT & INSYNC SENTRY & MAXIMO FAMILY (P010031/S095) | Medtronic Cardiac Rhythm Disease Management | 2008-04-18 |
| THERA-I IPG (P890003/S137) | Medtronic, Inc. | 2008-04-18 |
| KAPPA 400 DR & SR (P970012/S034) | Medtronic, Inc. | 2008-04-18 |
| ENRHYTHM (P980035/S091) | Medtronic, Inc. | 2008-04-18 |
| DEMA FAMILIES & DIVA FAMILIES & SELECTION AFM & C-SERIES & T- SERIES (P990001/S037) | Medtronic, Inc. | 2008-04-18 |
| SPRINT & SPRINT QUATTRO & SPRINT QUATTRO SECURE (P920015/S041) | Medtronic, Inc. | 2008-04-18 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S009) | W. L. Gore & Associates, Inc. | 2008-04-18 |
| UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P970034/S010) | Aaren Scientific | 2008-04-17 |
| VENTAK AV ICD (P960040/S164) | Boston Scientific | 2008-04-17 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S010) | Zoll Manufacturing Corporation | 2008-04-17 |
| LIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) MODELS H220, H225, H227, AND H229 (P010012/S176) | Boston Scientific Corp | 2008-04-17 |
| STAAR SURGICAL IMPLANTABLE COLLAMER LENSES (P030016/S004) | STAAR Surgical Company | 2008-04-16 |
| ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER (P010020/S006) | Boston Scientific Corp | 2008-04-16 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S010) | Boston Scientific Corp | 2008-04-16 |
| HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S026) | CooperSurgical, Inc. | 2008-04-16 |
| STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P990013/S016) | Starr Surgical Co. | 2008-04-16 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S013) | Ortho-Clinical Diagnostics, Inc. | 2008-04-16 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S031) | Integra LifeSciences Corporation | 2008-04-15 |
| COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S017) | Integra Lifesciences Corp. | 2008-04-15 |
| MEDTRONIC VASCULAR ANEURX AAADVANTAGE STENT GRAFT SYSTEM (P990020/S031) | Medtronic Vascular | 2008-04-15 |
| THE TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027) | Medtronic Vascular | 2008-04-15 |
| HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S028) | Integra LifeSciences Corporation | 2008-04-15 |
| FIRE STAR RX PTCA & DURA STAR RX PTCA BALLOON DILATATION CATHETER (P880003/S094) | Cordis Corp. | 2008-04-15 |
| TARGIS SYSTEM (P970008/S033) | Urologix, LLC | 2008-04-15 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S019) | Integra Lifesciences Corp. | 2008-04-15 |
| CORDIS PRECISE NITINOL STENT (P030047/S009) | Cordis US Corporation | 2008-04-14 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S048) | Boston Scientific Corp | 2008-04-11 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S040) | Boston Scientific Corp | 2008-04-11 |
| TRILOGY AB ACETABULAR SYSTEM (P040048/S003) | Zimmer, Inc. | 2008-04-11 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S005) | Allergan | 2008-04-11 |
| GORE VIATORR TIPS ENDOPROTHESIS (P040027/S007) | W. L. Gore & Associates, Inc. | 2008-04-11 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S045) | Boston Scientific Corp | 2008-04-11 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S018) | W. L. Gore & Associates, Inc. | 2008-04-11 |
| NEOVENTA'S STAN S31 FETAL HEART MONITOR (P020001/S004) | Neoventa Medical AB | 2008-04-11 |
| CYLOS DR, PROTOS DR-CLS, PHILOS 2 DR, PHILOS DR, AXIOS DR (P950037/S058) | Biotronik, Inc. | 2008-04-11 |
| CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S171) | ABBOTT MEDICAL | 2008-04-11 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S028) | W. L. Gore & Associates, Inc. | 2008-04-11 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S047) | Boston Scientific Corp | 2008-04-11 |
| SYNCHROMED II IMPLANTABLE INFUSION PUMP (P860004/S098) | Medtronic, Inc. | 2008-04-10 |
| PRIME FAMILIES OF IMPLANTABLE NEUROSTIMULATOR (P840001/S108) | Medtronic Neuromodulation | 2008-04-10 |
| INTERSTIM II NEUROSTIMULATOR (P970004/S051) | Medtronic Neuromodulation | 2008-04-10 |
| ACRYSOF RESTOR ASPHERIC INTRAOCULAR LENSES (P040020/S009) | Alcon Research, Ltd. | 2008-04-09 |
| NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM (P050025/S008) | Boston Scientific | 2008-04-09 |
| STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S028) | Amo Manufacturing USA, LLC | 2008-04-09 |
| REALIZE ADJUSTABLE GASTRIC BAND/REALIZE INJECTION PORT (P070009/S002) | Obtech Medical GmbH | 2008-04-09 |
| CORDIS PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S013) | Cordis US Corporation | 2008-04-09 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S039) | Boston Scientific Corp | 2008-04-09 |
| DEFLUX INJECTABLE GEL (P000029/S040) | Palette Life Sciences | 2008-04-08 |
| DEFLUX INJECTABLE GEL (P000029/S041) | Palette Life Sciences | 2008-04-08 |
| RESTYLANE INJECTABLE GEL (P040024/S020) | Q-Med AB | 2008-04-08 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH OPUS 2 SPEECH PROCESSOR (P000025/S029) | Med-El Corp. | 2008-04-08 |
| UROLOGIX TARGIS SYSTEM (P970008/S034) | Urologix, LLC | 2008-04-07 |
| FRONTIER AND FRONTIER II FAMILIES OF PACEMAKERS (P030035/S040) | ABBOTT MEDICAL | 2008-04-04 |
| IDENTITY, INTEGRITY, VERITY, VICTORY, AND ZEPHYR FAMILIES OF PACEMAKERS (P880086/S161) | ABBOTT MEDICAL | 2008-04-04 |