| Various models of single chamber ICDS in the Lumax, Ilesto, Iforia, Iperia, Itrevia, Inventra Families, Various models o (P050023/S099) | Biotronik, Inc. | 2016-06-24 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S076) | Medtronic | 2016-06-24 |
| ORCHESTRA AND ORCHESTRA PLUS PROGRAMMER (P980049/S109) | MicroPort CRM USA, Inc. | 2016-06-24 |
| IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S019) | Medtronic, Inc. | 2016-06-24 |
| MITRACLIP NT CLIP DELIVERY SYSTEM (P100009/S019) | ABBOTT MEDICAL | 2016-06-24 |
| THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETER, SAFIRE BLU ABLATION CATHETER (P060019/S037) | Irvine Biomedical, Inc. | 2016-06-24 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S094) | Medtronic, Inc. | 2016-06-24 |
| THERAPY DUAL 8 THERAPY 8MM THERMISTER ABLATION CATHETER, SAFIRE TX BI-DIRECTIONAL ABLATION CATHETER (P040042/S035) | Irvine Biomedical,Inc.(Ibi) | 2016-06-24 |
| RADIESSE INJECTABLE IMPLANT (P050037/S071) | Merz North America, Inc. | 2016-06-23 |
| RES-Q and RES-Q MICRON ICD and ICD Lead Family (P940008/S032) | Boston Scientific | 2016-06-23 |
| RADIESSE INJECTABLE IMPLANT (P050052/S083) | Merz North America, Inc. | 2016-06-23 |
| FOCUS NIGHT AND DAY (LOTRAFILCON A AND B) EXTENDED WEAR SOFT CONTACT LENSES (P010019/S051) | Alcon Laboratories, Inc. | 2016-06-23 |
| SWEET TIP RX, SWEET PICOTIP Rx, and FLEXTEND Pacing Lead Families (P960006/S046) | Boston Scientific | 2016-06-23 |
| Blazer II, Blazer II HTD, Blazer Prime HTD (P920047/S091) | Boston Scientific Corp | 2016-06-23 |
| Contak CD, Contak Renewal, Livian ICD Families; EasyTrak, Acuity Spiral Lead Families; Cognis, Energen, Incepta, Origen, (P010012/S422) | Boston Scientific Corp | 2016-06-23 |
| THINLINE/FINELINE Family of ENDOCARDIAL PACING LEADS (P960004/S076) | Boston Scientific | 2016-06-23 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S008) | Boston Scientific | 2016-06-23 |
| AUGMENT BONE GRAFT (P100006/S004) | Biomimetic Therapeutics, LLC | 2016-06-23 |
| VENTAK(R) P2 ICD FAMILY (P930035/S028) | Boston Scientific | 2016-06-23 |
| SELUTE Pacing Lead Family (P950001/S028) | Boston Scientific | 2016-06-23 |
| AKREOS INTRAOCULAR LENS,MODEL AO60 and MI60L (P060022/S023) | Bausch & Lomb, Inc. | 2016-06-23 |
| Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav XP, IntellaNav MiFi XP (P020025/S087) | Boston Scientific | 2016-06-23 |
| ENDOTAK LEAD SYSTEM (P910073/S135) | Boston Scientific | 2016-06-23 |
| VENTAK ICD Family (P830060/S081) | Boston Scientific | 2016-06-23 |
| CHILLI COOLED RF ABLATION SYSTEM (P980003/S066) | Boston Scientific Corp | 2016-06-23 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S146) | Cochlear Americas | 2016-06-23 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S007) | Boston Scientific Corp | 2016-06-23 |
| VENTAK PRX and VENTAK MINI ICD Families (P910077/S153) | Boston Scientific | 2016-06-23 |
| FOCUS NIGHT & DAY (LOTRAFILCON A) EXTENDED WEAR SOFT CONTACT LENSES (P000030/S003) | Alcon Laboratories, Inc. | 2016-06-23 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S075) | Medtronic | 2016-06-23 |
| ENVISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS, MODEL MX60 (P910056/S023) | Bausch & Lomb, Inc. | 2016-06-23 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESIS (P860057/S149) | Edwards Lifesciences, LLC | 2016-06-23 |
| TMR HOLMIUM LASER SYSTEM (P970029/S030) | Cryolife, Inc. | 2016-06-23 |
| MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS (P030053/S034) | Mentor Corp. | 2016-06-22 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S071) | Medtronic Vascular | 2016-06-22 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S072) | Integra LifeSciences Corporation | 2016-06-22 |
| HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S071) | Integra LifeSciences Corporation | 2016-06-22 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S008) | Nuvectra Corporation | 2016-06-22 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023/S019) | Medtronic Vascular, Inc. | 2016-06-22 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR Pacemakers (P950029/S110) | MicroPort CRM USA, Inc. | 2016-06-22 |
| MEDTRONIC COREVALVE(R) EVOLUT R SYSTEM (P130021/S021) | Medtronic, Inc. | 2016-06-21 |
| TMR HOLMIUM LASER SYSTEM (P970029/S029) | Cryolife, Inc. | 2016-06-21 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S140) | Cochlear Americas | 2016-06-20 |
| ESSENTIO VALITUDE MRI: L110, L111, L131;PROPONENT VALITUDE MRI: L210, L211, L231; ACCOLADE VALITUDE MRI: L310, L311, (P150012/S007) | Boston Scientific | 2016-06-20 |
| ORIGEN EL ICD: D050, D051, D052, D053; INOGEN EL ICD: D140, D141, D142, D143; DYNAGEN EL ICD: D150, D151, D152, D1 (P960040/S373) | Boston Scientific | 2016-06-20 |
| Ingenio 2 Pacemakers; ALTRUA 2 Models: S701, S702, S722; ESSENTIO Models: L100, L101, L121; PROPONENT Models: L200, (N970003/S190) | Boston Scientific Corp | 2016-06-20 |
| DYNAGEN CRT-D: G150, G151, G154 DYNAGEN X4 CRT-D: G156, G158; INOGEN CRT-D: G140, G141 INOGEN X4 CRT-D: G146, G1 (P010012/S421) | Boston Scientific Corp | 2016-06-20 |
| Ingenio 2 CRT-P Devices; VALITUDE Model: U125; VALITUDE X4 Model: U128 (P030005/S137) | Guidant Corp. | 2016-06-20 |
| BD TOTALYS SLIDEPREP (P970018/S034) | Bd Diagnostic Systems | 2016-06-17 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S076) | Zoll Manufacturing Corporation | 2016-06-17 |
| TECNIS 1-PIECE IOL, TECNIS 1-PIECE OPTIBLUE IOL, PRELOADED TECNIS 1-PIECE IOL, PRELOADED TECNIS 1-PIECE OPTIBLUE IOL, PR (P980040/S069) | Johnson & Johnson Surgical Vision, Inc. | 2016-06-17 |
| BD FOCALPOINT GS IMAGING SYSTEM (P950009/S021) | Bd Diagnostics | 2016-06-17 |
| BRACANALYSIS CDx (P140020/S007) | Myriad Genetic Laboratories | 2016-06-17 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (Monorail) (P150003/S013) | Boston Scientific Corporation | 2016-06-17 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S052) | ABBOTT MEDICAL | 2016-06-17 |
| BRACANALYSIS CDX (P140020/S006) | Myriad Genetic Laboratories | 2016-06-17 |
| SURGICEL FAMILY OF ABSORBABLE HEMOSTAT (N12159/S037) | ETHICON, Inc. | 2016-06-17 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S036) | DePuy Orthopaedics, Inc. | 2016-06-17 |
| IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029) | Medtronic Minimed | 2016-06-17 |
| TECNIS ACRYLIC MONOFOCAL IOL (P990080/S041) | Johnson & Johnson Surgical Vision, Inc. | 2016-06-17 |
| Sprint Quattro Lead (P920015/S180) | Medtronic, Inc. | 2016-06-17 |
| PROPEL AND PROPEL MINI SINUS IMPLANTS (P100044/S021) | Intersect Ent. | 2016-06-17 |
| SPECTRANETICS LASER SHEATHS (P960042/S054) | Spectranetics (Philips) | 2016-06-16 |
| MyCareLink Patient Monitor 24950 (P890003/S355) | Medtronic, Inc. | 2016-06-16 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S014) | Boston Scientific Corporation | 2016-06-16 |
| ANIMAS VIBE SYSTEM (P130007/S011) | Animas Corp. | 2016-06-16 |
| MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM (P100021/S052) | Medtronic Vascular | 2016-06-16 |
| AMPLIA MRI, AMPLIA MRI QUAD, BRAVA, BRAVA QUAD, COMPIA MRI,COMPIA MRI QUAD, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT C (P010031/S547) | Medtronic Cardiac Rhythm Disease Management | 2016-06-16 |
| EVERA MRI, EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR, VISIA AF MRI VR, VISIA AF VR ICD. (P980016/S587) | Medtronic Cardiac Rhythm Disease Management | 2016-06-16 |
| EXCIMER LASER CORONARY ATHERECTOMY CATHETER (P910001/S086) | Spectranetics Corp. | 2016-06-16 |
| PROMRI ICD SYSTEM (P050023/S095) | Biotronik, Inc. | 2016-06-16 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND PROMUS PREMIER EVEROLIMUS-ELUTING PLA (P110010/S126) | Boston Scientific Corp | 2016-06-16 |
| Integrity Coronary Stent Systems (P030009/S087) | Medtronic, Ireland | 2016-06-15 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S070) | Medtronic Vascular | 2016-06-15 |
| PMMA ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P840039/S061) | Bausch & Lomb, Inc. | 2016-06-15 |
| INGEVITY LEADS (P150012/S005) | Boston Scientific | 2016-06-15 |
| PMMA ABSORBING ANTERIOR CHAMBER INTRAOCULAR LENSES (P880090/S029) | Bausch & Lomb, Inc. | 2016-06-15 |
| THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S062) | Thoratec Laboratories Corp. | 2016-06-14 |
| HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVI (P810031/S056) | Johnson & Johnson Surgical Vision, Inc. | 2016-06-14 |
| Concerto II CRT-D D274TRK, Consulta CRT-D D204TRM, Consulta CRT-D D224TRK, Maximo II CRT-D D264TRM, D284TRK, Protecta CR (P010031/S552) | Medtronic Cardiac Rhythm Disease Management | 2016-06-14 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S073) | Zoll Manufacturing Corporation | 2016-06-14 |
| NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S005) | Nevro Corporation | 2016-06-14 |
| Maximo II ICD D264DRM, D264VRM, D284VRC, D284DRG; Protecta ICD D334DRG, D334VRG, D334DRM, D334VRM; Protecta XT ICD D314D (P980016/S591) | Medtronic Cardiac Rhythm Disease Management | 2016-06-14 |
| AspireAssist (P150024) | Aspire Bariatrics, Inc. | 2016-06-14 |
| FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL), (UNI-DIRECTIONAL) (P110016/S032) | ABBOTT MEDICAL | 2016-06-14 |
| NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT (P000015/S012) | Cochlear Americas | 2016-06-13 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S126) | W. L. Gore & Associates, Inc. | 2016-06-13 |
| NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS (P040046/S015) | Allergan | 2016-06-13 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S033) | Allergan | 2016-06-13 |
| ABBOTT REALTIME HCV ASSAY, ABBOTT REALTIME HCV CALIBRATOR KIT, ABBOTT REALTIME HCV CONTROL KIT, ABBOTT MSAMPLE PREPARATI (P100017/S017) | Abbott Molecular, Inc. | 2016-06-10 |
| RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S069) | Medtronic Vascular | 2016-06-10 |
| EDWARD SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S017) | Edwards Lifesciences, LLC | 2016-06-10 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S004) | Nuvectra Corporation | 2016-06-10 |
| CLOSER VASCULAR SEALING SYSTEM (P150022/S001) | Rex Medical, L.P. | 2016-06-10 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S059) | Edwards Lifesciences, LLC | 2016-06-10 |
| ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM (P120012/S013) | Abbott Molecular | 2016-06-10 |
| BIOFINITY (COMFILCON A) Soft (Hydrophilic) Contact Lenses (P080011/S044) | CooperVision, Inc. | 2016-06-10 |
| S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S037) | Cordis US Corporation | 2016-06-09 |
| BIOFINITY (COMFILCON A) Soft (Hydrophilic) Contact Lenses (P080011/S045) | CooperVision, Inc. | 2016-06-09 |
| ACUITY X4 (Straight,Spiral S, Spiral L) Steroid-eluting, Coronary Venous, QUADRIPOLAR ACE/SENSE LEADS (P010012/S416) | Boston Scientific Corp | 2016-06-09 |