| EZ STEER BI-DIRECTIONAL NON NAV 4 MM TIP WITH THERMOCOUPLE, 7F EZ NON-NAV CATHETER W/4MM TIP ELECTRODE AND THERMISTOR (P950005/S044) | Biosense Webster, Inc. | 2013-05-29 |
| 7.5 FR NAVI-STAR THERMO-COOL VATHETER WITH THERMISTOR (P040036/S036) | Biosense Webster, Inc. | 2013-05-29 |
| SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE SVC LEAD (P920015/S111) | Medtronic, Inc. | 2013-05-29 |
| CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,VITATRON CRYSTALLINE LEAD,VITATRON PIROUET LEAD (P930039/S088) | Medtronic, Inc. | 2013-05-29 |
| BIOMERIEUX THXID BRAF ASSAY KIT (P120014) | bioMerieux, Inc. | 2013-05-29 |
| 7F EZ STEER DS BI-DIRECTIONAL NAV CATHETER 4MM TIP ELECTRODE AND THERMOCOUPLE (P990025/S037) | Biosense Webster, Inc. | 2013-05-29 |
| DURATA FAMILY OF HIGH VOLTAGE LEADS (P950022/S086) | ABBOTT MEDICAL | 2013-05-29 |
| BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR (P100025/S004) | Meridian Bioscience, Inc. | 2013-05-29 |
| ATTAIN BIPOLAR OTW LEAD,LEFT VENTRICULAR PACING LEAD (P010015/S200) | Medtronic, Inc. | 2013-05-29 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S049) | Medtronic, Inc. | 2013-05-29 |
| CELERITY,COROX,ENTOVIS HF(-T),EVIA HF (-T),STRATOS (P070008/S043) | Biotronik, Inc. | 2013-05-29 |
| SELECTSECURE LEAD (P030036/S057) | Medtronic Cardiac Rhythm Disease Management | 2013-05-29 |
| ATTAIN ABILITY LEAD (P080006/S053) | Medtronic, Inc. | 2013-05-29 |
| CAPSUREFIX MRI LEAD (P090013/S097) | Medtronic, Inc. | 2013-05-29 |
| TRANSVENE LEAD (P980050/S083) | Medtronic, Inc. | 2013-05-29 |
| CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,IMPULSE II LEAD (P850089/S097) | Medtronic Cardiac Rhythm Disease Management | 2013-05-29 |
| 7F CELCIUS THERMO-COOL CATHETER WITH THERMOCOUPLEM, 7F CELCIUS THERMOCOOL CATHETER WITH THERMMISTOR (P030031/S052) | Biosense Webster, Inc. | 2013-05-29 |
| ILESTO,IFORIA,LUMAX (P050023/S065) | Biotronik, Inc. | 2013-05-29 |
| CAPSURE LEAD,VITATRON CRYSTALINE LEAD,VITATRON EXCELLENCE PS+LEAD (P830061/S092) | Medtronic Cardiac Rhythm Disease Management | 2013-05-29 |
| 7 FR EZ STEER NAV DS BI-DIRECTIONAL W/ 8MM TIP ELECTRODE W/ DUAL THERMOCOUPLE (P010068/S034) | Biosense Webster, Inc. | 2013-05-29 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S013) | Medtronic Vascular | 2013-05-29 |
| ABBOTT REALTIME HBV (P080026/S007) | Abbott Molecular, Inc. | 2013-05-28 |
| HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICES (OVD) (P110007/S003) | Johnson & Johnson Surgical Vision, Inc. | 2013-05-28 |
| SCULPTRA AESTHETIC (P030050/S014) | Q-Med AB | 2013-05-28 |
| DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE (P000021/S025) | Siemens Healthcare Diagnostics | 2013-05-28 |
| AARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS (P100016/S001) | Carl Zeiss Meditec Production, LLC | 2013-05-28 |
| SPF IMPLANTABLE SPINAL FUSION STIMULATORS (P850035/S035) | Ahp Eos Buyer, Inc. | 2013-05-28 |
| EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S049) | Ahp Eos Buyer, Inc. | 2013-05-28 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S091) | Cochlear Americas | 2013-05-28 |
| DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE (P020027/S020) | Siemens Healthcare Diagnostics | 2013-05-28 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S011) | OraSure Technologies, Inc. | 2013-05-28 |
| ABBOTT REALTIME HCV (P100017/S006) | Abbott Molecular, Inc. | 2013-05-28 |
| REVO MRI IPG (P090013/S085) | Medtronic, Inc. | 2013-05-24 |
| MYCARELINK PATIENT MONITOR (P890003/S269) | Medtronic, Inc. | 2013-05-24 |
| ADAPTA VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG AND ENPULSE E1 IPG (P980035/S311) | Medtronic, Inc. | 2013-05-24 |
| INSYNC II P ROTECT ICD, INSYNC III MARQUIS ICD, INSYNC MARQUIS ICD, INSYNC MAXIMO ICD (P010031/S363) | Medtronic Cardiac Rhythm Disease Management | 2013-05-24 |
| ENTRUST ICD, INTRINSIC 30 ICD, INTRINSIC ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO VR IC (P980016/S400) | Medtronic Cardiac Rhythm Disease Management | 2013-05-24 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S190) | Medtronic, Inc. | 2013-05-24 |
| EYEJET INJECTOR (P010059/S004) | Morcher GmbH | 2013-05-23 |
| CAPSURE SENSE BIPOLAR LEAD (P830061/S091) | Medtronic Cardiac Rhythm Disease Management | 2013-05-23 |
| CAPSUREFIX MRI SURESCAN LEAD (P090013/S096) | Medtronic, Inc. | 2013-05-23 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S143) | Boston Scientific Corp | 2013-05-23 |
| DERMAGRAFT (HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE) (P000036/S017) | Shire Regenerative Medicine | 2013-05-23 |
| INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P) (P030005/S092) | Guidant Corp. | 2013-05-23 |
| CAPSUREFIX NOVUS LEAD (P930039/S087) | Medtronic, Inc. | 2013-05-23 |
| ROTABLATOR ROTALINK ADVANCER AND ROTALINK PLUS (P900056/S121) | Boston Scientific Corp | 2013-05-23 |
| ADAPTA/VERSA/SENSIA IPG (P980035/S323) | Medtronic, Inc. | 2013-05-23 |
| XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S109) | Abbott Vascular, Inc. | 2013-05-23 |
| SYNCHROMED PUMP AND INFUSION SYSTEM (P860004/S191) | Medtronic, Inc. | 2013-05-23 |
| BREATH TEK UBT FOR H PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION(PUHR-CA) (P100025/S002) | Meridian Bioscience, Inc. | 2013-05-23 |
| RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDWARDS TRANSFEMORAL BALLOON CATHETER, CRIMPER, ASCENDRA BALLOO (P110021/S013) | Edwards Lifesciences, LLC | 2013-05-22 |
| RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLON CATHETER, EDWARDS TRANSFEMORAL BALLON CATHETER, CRIMPER (P100041/S027) | Edwards Lifesciences, LLC | 2013-05-22 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S019) | Medtronic | 2013-05-22 |
| DEFLUX INJECTABLE GEL (P000029/S074) | Palette Life Sciences | 2013-05-22 |
| PROPEL SINUS IMPLANT (P100044/S004) | Intersect Ent. | 2013-05-22 |
| EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR,MAXIMO II,PROTECTA,PROTECTA XT,SECURA,VIRTUOSO II DR/VR ICDS (P980016/S415) | Medtronic Cardiac Rhythm Disease Management | 2013-05-22 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S010) | Medtronic Vascular | 2013-05-22 |
| ARCHITECT ANTI-HCV (P050042/S024) | Abbott Laboratories, Inc. | 2013-05-22 |
| BRAVA,CONCERTO II,MAXIMO II,PROTECTA,PROTECTA XT,VIVA S,VIVA XT CRTS,CONSULTA ICD (P010031/S375) | Medtronic Cardiac Rhythm Disease Management | 2013-05-22 |
| PMMA SINGLE PIECE POSTERIOR CHAMBER (P840060/S040) | Alcon Laboratories | 2013-05-21 |
| XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S044) | Abbott Vascular | 2013-05-21 |
| VNS THERAPY GENERATOR(PULSE AND PULSE DUO) (ASPIREHC) (P970003/S163) | LivaNova USA, Inc. | 2013-05-21 |
| DERMAGRAFT (HUMAN FIBROBLAST -DERIVED DERMAL SUBSTITUTE) (P000036/S018) | Shire Regenerative Medicine | 2013-05-21 |
| ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S047) | Alcon Research, Ltd. | 2013-05-21 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S068) | Alcon Laboratories, Inc. | 2013-05-21 |
| PMMA SINGLE PIECE ANTERIOR CHAMBER (P880087/S022) | Alcon Laboratories | 2013-05-21 |
| DERMAGRAFT (P000036/S016) | Shire Regenerative Medicine | 2013-05-21 |
| ZENITH TX2 THORACIC ENDOVASCULAR GRAFT (P070016/S007) | William Cook Europe Aps | 2013-05-20 |
| TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS (P030002/S027) | Bausch & Lomb, Inc. | 2013-05-20 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S098) | Advanced Bionics | 2013-05-20 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER - RAPID EXCHANGE (RX), ANGIOSCULPT PTCS SCORING BALLOON CATHETER - EASY EXCHAN (P050018/S018) | Spectranetics Corp. | 2013-05-20 |
| EON MINI 2.0 SYSTEM (P010032/S068) | ABBOTT MEDICAL | 2013-05-17 |
| ESTEEM IMPLANTABLE HEARING SYSTEM (P090018/S019) | Envoy Medical Corporation | 2013-05-17 |
| TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM (P990027/S018) | Technolas Perfect Vision GmbH | 2013-05-17 |
| CELERITY,COROX (P070008/S042) | Biotronik, Inc. | 2013-05-17 |
| COROX OTW 75 UP STEROID,COROX OTW 85 UP STEROID (P050023/S064) | Biotronik, Inc. | 2013-05-17 |
| KAINOX VCS,LINOX,LINOX SMART,VIGILA,VOLTA (P980023/S053) | Biotronik, Inc. | 2013-05-17 |
| DEXTRUS,SELOX,SETROX S,SOLOX,TILDA (P950037/S122) | Biotronik, Inc. | 2013-05-17 |
| MYNXCADENCE AND MYNXGRIP VASCULAR DEVICES (P040044/S048) | Cordis US Corporation | 2013-05-17 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR, 203/203A (P850064/S021) | Bunnell, Inc. | 2013-05-16 |
| MED-EL COMBI 40+ COHLEAR IMPLANT SYSTEM (P000025/S068) | Med-El Corp. | 2013-05-16 |
| PROMETRA PROGRAMMABLE IMPLANTABLE PUMP (P080012/S017) | Infusyn Therapeutics, LLC | 2013-05-16 |
| SELENIA DIMENSIONS 3D SYSTEM (P080003/S001) | Hologic, Inc. | 2013-05-16 |
| VECTRIS SURESCAN MRI 1X8 LEADS, VECTRIS 1X8 TRIALING LEADS (P840001/S239) | Medtronic Neuromodulation | 2013-05-16 |
| GENESYS HTA SYSTEM (P000040/S027) | Axora Medical, Inc. | 2013-05-16 |
| SILIKON 1000 OCULAR ENDOTAMPONADE (P950008/S009) | Alcon | 2013-05-15 |
| ADVISA DR IPR, ADVISA DR MRI IPG (P980035/S317) | Medtronic, Inc. | 2013-05-15 |
| SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER IOL (P910056/S014) | Bausch & Lomb, Inc. | 2013-05-15 |
| WAVELIGHT LASER SYSTEM (P030008/S011) | Alcon Laboratories, Inc. | 2013-05-15 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S069) | Boston Scientific Corp | 2013-05-15 |
| MENTOR SALINE-FILLED BREAST IMPLANTS (P990075/S023) | Mentor Worldwide, LLC | 2013-05-15 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S014) | Medtronic | 2013-05-15 |
| WAVELIGHT EX500 EXCIMER LASER SYSTEM (P020050/S013) | Alcon Laboratories, Inc. | 2013-05-15 |
| REGENCY, SENSLOG AND DIALOG (P880006/S086) | St. Jude Medical, Inc. | 2013-05-14 |
| REVO MRI IPG (P090013/S095) | Medtronic, Inc. | 2013-05-14 |
| MICRONY (P970013/S056) | ABBOTT MEDICAL | 2013-05-14 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) (P110042/S008) | Boston Scientific Corporation | 2013-05-14 |
| ADDVENT, AFFINITY, IDENTITY, VERITY, INTEGRITY, VICTORY, ZEPHYR, ACCENT, TRIOLOGY, SYNCHRONY AND PARAGON (P880086/S232) | ABBOTT MEDICAL | 2013-05-14 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S199) | Medtronic, Inc. | 2013-05-14 |
| FRONTIER, FRONTIER II AND ANTHEM (P030035/S110) | ABBOTT MEDICAL | 2013-05-14 |