| ARCTIC FRONT FAMILY CARDIAC CRYOABLATION CATHETERS (P100010/S057) | Medtronic Cryocath, LP | 2016-07-07 |
| RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULAT (P840001/S330) | Medtronic Neuromodulation | 2016-07-07 |
| INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S216) | Medtronic Neuromodulation | 2016-07-07 |
| PRESTIGE LP(TM) CERVICAL DISC (P090029/S003) | Medtronic Sofamor Danek USA, Inc. | 2016-07-07 |
| PLATINIUM CRT-D (MODELS 1711 AND 1741) (P060027/S079) | MicroPort CRM USA, Inc. | 2016-07-07 |
| INTERSTIM THERAPY SYSTEM (P970004/S215) | Medtronic Neuromodulation | 2016-07-07 |
| PLATINIUM VR (MODELS 1210 AND 1240) AND PLATINIUM DR (MODELS 1510 AND 1540) ICDS (P980049/S113) | MicroPort CRM USA, Inc. | 2016-07-07 |
| GORE EXCLUDER AAA ENDOPROSTHESIS & ILIAC BRANCH ENDOPROSTHESIS (P020004/S132) | W. L. Gore & Associates, Inc. | 2016-07-07 |
| FREEZOR FAMILY CARDIAC CRYOABLATION CATHETERS (P020045/S076) | Medtronic Cryocath, LP | 2016-07-07 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S024) | Cryolife, Inc. | 2016-07-07 |
| INTERSTIM THERAPY SYSTEM (P080025/S110) | Medtronic Neuromodulation | 2016-07-07 |
| BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS, BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS (P920047/S092) | Boston Scientific Corp | 2016-07-07 |
| SYNCHROMED INFUSION SYSTEM (P860004/S253) | Medtronic, Inc. | 2016-07-07 |
| ATTAIN STARFIX MODEL 4195 LEAD (P060039/S070) | Medtronic, Inc. | 2016-07-07 |
| SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P080003/S003) | Hologic, Inc. | 2016-07-07 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S253) | Medtronic, Inc. | 2016-07-07 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULA (P840001/S332) | Medtronic Neuromodulation | 2016-07-07 |
| INTELLATIP MIFI XP TEMPERATURE ABLATION SYSTEM (P020025/S088) | Boston Scientific | 2016-07-07 |
| SYNCHROMED INFUSION SYSTEM (P860004/S252) | Medtronic, Inc. | 2016-07-07 |
| INTELLANAV OPEN-IRRIGATED ABLATION CATHETER (P150005/S005) | Boston Scientific Corp | 2016-07-07 |
| SYNCHROMED INFUSION SYSTEM (P860004/S251) | Medtronic, Inc. | 2016-07-07 |
| SCULPTRA AND SCULPTRA AESTHETIC (P030050/S024) | Q-Med AB | 2016-07-07 |
| SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S087) | Spectranetics Corp. | 2016-07-07 |
| COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS (P100020/S017) | Roche Molecular Systems, Inc. | 2016-07-07 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S254) | Medtronic, Inc. | 2016-07-07 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S077) | Zoll Manufacturing Corporation | 2016-07-07 |
| INTERSTIM THERAPY SYSTEM FOR BOWEL (P080025/S111) | Medtronic Neuromodulation | 2016-07-07 |
| RINGJECT (P030023/S005) | Ophtec BV | 2016-07-06 |
| ADVISA DR IPG, DR MRI IPG, SR MRI IPG (P980035/S466) | Medtronic, Inc. | 2016-07-06 |
| ANIMAS VIBE SYSTEM (P130007/S014) | Animas Corp. | 2016-07-06 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S301) | Medtronic, Inc. | 2016-07-06 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P110013/S072) | Medtronic Vascular | 2016-07-06 |
| MYNX ACE VASCULAR CLOSURE DEVICE (P040044/S073) | Cordis US Corporation | 2016-07-06 |
| MEDTRONIC SPINAL CORD STIMULATION THERAPY (P840001/S331) | Medtronic Neuromodulation | 2016-07-06 |
| REVO MRI SURESCAN IPG (P090013/S227) | Medtronic, Inc. | 2016-07-06 |
| IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S013) | Medtronic, Inc. | 2016-07-06 |
| MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S018) | Mentor Worldwide, LLC | 2016-07-05 |
| ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM (P150023) | Abbott Vascular, Inc. | 2016-07-05 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S001) | Boston Scientific Corp | 2016-07-05 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S003) | Boston Scientific Corporation | 2016-07-05 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM (P030011/S044) | Syncardia Systems, LLC | 2016-07-05 |
| MITRACLIP AND MITRACLIP NT CLIP DELIVERY SYSTEM (P100009/S020) | ABBOTT MEDICAL | 2016-07-05 |
| MENTOR MEMORYGEL BREAST IMPLANTS (P030053/S035) | Mentor Corp. | 2016-07-05 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S006) | Boston Scientific Corp | 2016-07-05 |
| MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS (P990075/S037) | Mentor Worldwide, LLC | 2016-07-05 |
| Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S150) | Edwards Lifesciences, LLC | 2016-07-05 |
| Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A (P980035/S465) | Medtronic, Inc. | 2016-07-05 |
| ZILVER VASCULAR STENT (P050017/S013) | Cook Ireland, Ltd. | 2016-07-01 |
| CARTIVA SYNTHETIC CARTILAGE IMPLANT (P150017) | Cartiva, Inc. | 2016-07-01 |
| Carpentier-Edwards PERIMOUNT (P860057/S151) | Edwards Lifesciences, LLC | 2016-07-01 |
| INTERSTIM THERAPY SYSTEM (BOWEL) (P080025/S109) | Medtronic Neuromodulation | 2016-07-01 |
| Prostar XL 10F Percutaneous Vascular Surgical System (P960043/S093) | Abbott Vascular, Inc. | 2016-07-01 |
| SURGICEL ABSORBABLE HEMOSTAT (N12159/S038) | ETHICON, Inc. | 2016-07-01 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S018) | Cook Ireland, Ltd. | 2016-07-01 |
| LCS(R) TOTAL KNEE SYSTEM (P830055/S171) | Depuy, Inc. | 2016-07-01 |
| INTERSTIM THERAPY SYSTEM (URINARY) (P970004/S214) | Medtronic Neuromodulation | 2016-07-01 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY (P960009/S252) | Medtronic, Inc. | 2016-07-01 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S037) | DePuy Orthopaedics, Inc. | 2016-07-01 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULA (P840001/S329) | Medtronic Neuromodulation | 2016-07-01 |
| ABBOTT REALTIME HCV ASSAY (P100017/S018) | Abbott Molecular, Inc. | 2016-06-30 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE TREATMENT (N970012/S116) | Boston Scientific Corp | 2016-06-30 |
| ANIMAS VIBE SYSTEM (P130007/S012) | Animas Corp. | 2016-06-30 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER WITH INHIBIZONE TREATMENT (P000053/S064) | Boston Scientific Corp | 2016-06-30 |
| ABBOTT REALTIME HCV GENOTYPE II ASSAY (P120012/S014) | Abbott Molecular | 2016-06-30 |
| CORDIS EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S013) | Cordis US Corporation | 2016-06-30 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S251) | Medtronic, Inc. | 2016-06-29 |
| PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S252) | Boston Scientific Corp | 2016-06-29 |
| LIVEWIRE TC ABLATION CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER (P960016/S066) | St Jude Medical | 2016-06-29 |
| RESTORE, ITREL, SYNERGY SPINAL CORD STIMULATION SYSTEMS. (P840001/S328) | Medtronic Neuromodulation | 2016-06-29 |
| Raindrop Near Vision Inlay (P150034) | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2016-06-29 |
| MICRONY PACEMAKERS (P970013/S069) | ABBOTT MEDICAL | 2016-06-28 |
| ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS (P880086/S272) | ABBOTT MEDICAL | 2016-06-28 |
| Quadra Assura/Unify Assura Family of CRt-Ds (P030054/S302) | ABBOTT MEDICAL | 2016-06-28 |
| Ellipse/Fortify Assura Family of ICDs (P910023/S371) | ABBOTT MEDICAL | 2016-06-28 |
| WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE (P130013/S010) | Boston Scientific Corp | 2016-06-28 |
| PHOTOFRIN 630 PDT LASER (P990021/S003) | Pinnacle Biologics, Inc. | 2016-06-28 |
| SPINAL CORD STIMULATION SYSTEM (GENESIS, ECO-C)IPG'S ; GENESIS, ECO, PROTEGE, PRODIGY) PATIENT PROGRAMMERS (P010032/S119) | ABBOTT MEDICAL | 2016-06-28 |
| LUTONIX DRUG COATED BALLOON PTA CATHETER (P130024/S011) | Lutonix | 2016-06-28 |
| ANTHEM AND FRONTIER II CRT-P'S (P030035/S146) | ABBOTT MEDICAL | 2016-06-28 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON ULTIMATE DUAL PACK, AND HEALON DUET (P810031/S057) | Johnson & Johnson Surgical Vision, Inc. | 2016-06-28 |
| DEEP BRAIN STIMULATION SYSTEM (LIBRA, LIBRA XP)IPG'S; (LIBRA, BRIO) CLINICIAN PROGRAMMERS (P140009/S016) | ABBOTT MEDICAL | 2016-06-28 |
| SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENSES (P910061/S023) | Bausch & Lomb | 2016-06-27 |
| RADIESSE Injectable Implant (P050037/S073) | Merz North America, Inc. | 2016-06-27 |
| REZOOM MULTIFOCAL INTRAOCULAR LENS (P960028/S039) | Johnson & Johnson Surgical Vision, Inc. | 2016-06-27 |
| RADIESSE (+) Lidocaine Dermal Filler (P050052/S085) | Merz North America, Inc. | 2016-06-27 |
| EXABLATE (P110039/S005) | Insightec | 2016-06-27 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S009) | Reshape Lifesciences, Inc. | 2016-06-27 |
| EXABLATE 2000 SYSTEM (P040003/S017) | Insightec, Ltd. | 2016-06-27 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S060) | Edwards Lifesciences, LLC | 2016-06-27 |
| SENSAR SOFT ACRYLIC INTRAOCULAR LENSES, TECNIS ACRYLIC INTRAOCULAR LENS, TECNIS ITEC PRELOADED DELIVERY SYSTEM. (P980040/S070) | Johnson & Johnson Surgical Vision, Inc. | 2016-06-27 |
| TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P080010/S013) | Johnson & Johnson Surgical Vision, Inc. | 2016-06-27 |
| COAPTITE Injectable Implant (P040047/S043) | Merz North America, Inc. | 2016-06-27 |
| TECNIS 3-PCS MONOFOCAL LENS (P990080/S042) | Johnson & Johnson Surgical Vision, Inc. | 2016-06-27 |
| COOL PATH DUO ABLATION CATHETER MEDIGUIDE ENABLED, AND SAFIRE DUO ABLATION CATHETER MEDIGUIDE ENABLED, THERAPY COOL PATH (P110016/S033) | ABBOTT MEDICAL | 2016-06-24 |
| NIRXCELL COCR CORONARY STENT ON RX SYSTEM (NIRXCELL STENT SYSTEM) (P110004/S017) | Medinol, Ltd. | 2016-06-24 |
| ENDURANT, ENDURANT II, ENDURANT II AORTO-UNI-ILIAC (AUI), ENDURANT IIS STENT GRAFT SYSTEM (P100021/S053) | Medtronic Vascular | 2016-06-24 |
| Various models of Evia, Entovis, Estella, Effecta, Ecuro, Eluna, Etrinsa, Epyra Pulse Generator Families (P950037/S163) | Biotronik, Inc. | 2016-06-24 |
| Stratos LV/LV-T, Evia/Entovis HF/HF-T, Eluna/Erinsa/Epyra 8 HF-T CRT-Ps (P070008/S073) | Biotronik, Inc. | 2016-06-24 |
| REPLY DR, REPLY SR, ESPRIT DR, ESPRIT SR (P950029/S105) | MicroPort CRM USA, Inc. | 2016-06-24 |
| THERAPY ABLATION CATHETER (INCLUDING BI-DIRECTIONAL) THERAPY 4MM THERMISTOR ABLATION CATHETER (P040014/S030) | Irvine Biomedical, Inc. | 2016-06-24 |