| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023/S021) | Medtronic Vascular, Inc. | 2016-11-23 |
| VNS THERAPY SYSTEM (P970003/S195) | LivaNova USA, Inc. | 2016-11-23 |
| GEL-ONE (P080020/S022) | Seikagaku Corp. | 2016-11-23 |
| Claria MRI CRT-D QUAD SureScan; Amplia MRI Quad CRT-D SureScan; Compia MRI CRT-D SureScan (P010031/S568) | Medtronic Cardiac Rhythm Disease Management | 2016-11-23 |
| INTERSTIM THERAPY SYSTEM (FOR URINARY CONTROL) (P970004/S228) | Medtronic Neuromodulation | 2016-11-23 |
| Evera MRI XT DR, VR, S DR, S VR SureScan ICD; Visia AF MRI XT, S VR SureScan ICD (P980016/S608) | Medtronic Cardiac Rhythm Disease Management | 2016-11-23 |
| DEMIPULSE MODEL 103; ASPIREHC MODEL 105; ASPIRESR MODEL 106 GENERATOR. (P970003/S200) | LivaNova USA, Inc. | 2016-11-23 |
| INTERSTIM THERAPY SYSTEM (FOR BOWEL CONTROL) (P080025/S123) | Medtronic Neuromodulation | 2016-11-23 |
| PRECISION NOVI SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S264) | Boston Scientific Corp | 2016-11-23 |
| BIOFINITY COMFILCON A SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P080011/S051) | CooperVision, Inc. | 2016-11-23 |
| Sprint Quattro Lead (P920015/S187) | Medtronic, Inc. | 2016-11-22 |
| ABBOTT REALTIME HBV ASSAY, CALIBRATOR KIT, CONTROL KIT; ABBOTT MSAMPLE PREPARATION SYSTEMDNA. (P080026/S018) | Abbott Molecular, Inc. | 2016-11-22 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S084) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2016-11-22 |
| ELECSYS FREE PSA (P000027/S024) | Roche Diagnostics Corp. | 2016-11-22 |
| Mi1200 Magnet Assembly (P000025/S090) | Med-El Corp. | 2016-11-22 |
| ThermoCool SmartTouch SF Bi-Directional & Uni-Directional Navigation Catheter's (P030031/S079) | Biosense Webster, Inc. | 2016-11-22 |
| ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM (P150023/S006) | Abbott Vascular, Inc. | 2016-11-22 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S078) | Medtronic Vascular | 2016-11-22 |
| LCS(R) TOTAL KNEE SYSTEM (P830055/S177) | Depuy, Inc. | 2016-11-22 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S061) | Vistakon, Division of Johnson & Johnson Vision Car | 2016-11-22 |
| ELECSYS HBSAG (P990012/S027) | Roche Diagnostics Corp. | 2016-11-22 |
| ELECSYS HBEAG (P130015/S008) | Roche Diagnostics Operations, Inc. | 2016-11-22 |
| HYMOVIS (P150010/S001) | Fidia Farmaceutici | 2016-11-22 |
| THxID-BRAF kit (P120014/S007) | bioMerieux, Inc. | 2016-11-22 |
| ELECSYS ANTI-HBS (P010054/S029) | Roche Diagnostics Corp. | 2016-11-22 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S042) | Baxter Healthcare Corp | 2016-11-22 |
| ELECSYS TOTAL PSA (P990056/S025) | Roche Diagnostics Corp. | 2016-11-22 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM WITH AND WITHOUT INHIBIZONE TREATMENT (P000053/S071) | Boston Scientific Corp | 2016-11-22 |
| CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A (P990080/S044) | Johnson & Johnson Surgical Vision, Inc. | 2016-11-21 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S053) | Medtronic, Inc. | 2016-11-21 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S001) | Boston Scientific Corp | 2016-11-21 |
| MOSAIC PORCINE BIOPROSTHETIC (P990064/S064) | Medtronic, Inc. | 2016-11-21 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S049) | Medtronic Heart Valves | 2016-11-21 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S055) | Medtronic, Inc. | 2016-11-21 |
| SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S075) | Johnson & Johnson Surgical Vision, Inc. | 2016-11-21 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S011) | Reshape Lifesciences, Inc. | 2016-11-21 |
| WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM (P020050/S023) | Alcon Laboratories, Inc. | 2016-11-21 |
| HANCOCK LOWPOROSITY VALVED CONDUIT (P870078/S034) | Medtronic, Inc. | 2016-11-21 |
| Durata Family Of High Voltage Leads (P950022/S097) | ABBOTT MEDICAL | 2016-11-20 |
| Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A (P980035/S480) | Medtronic, Inc. | 2016-11-20 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S023) | Boston Scientific Corporation | 2016-11-18 |
| SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S007) | Nevro Corporation | 2016-11-18 |
| Epi proColon (P130001/S001) | New Day Diagnostics, LLC | 2016-11-18 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S034) | Beckman Coulter, Inc. | 2016-11-18 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S024) | Boston Scientific Corporation | 2016-11-18 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S024) | OraSure Technologies, Inc. | 2016-11-18 |
| SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S067) | Johnson & Johnson Surgical Vision, Inc. | 2016-11-18 |
| MyCareLink Patient Monitor Model 24950 (P890003/S365) | Medtronic, Inc. | 2016-11-17 |
| CyPass Stent (P150037/S003) | Alcon Research, Ltd. | 2016-11-17 |
| ALLURE QUADRA, RF, MP (P030035/S150) | ABBOTT MEDICAL | 2016-11-17 |
| REVO MRI SURESCAN IPG (P090013/S235) | Medtronic, Inc. | 2016-11-17 |
| COLOGUARD (P130017/S012) | Exact Sciences Corporation | 2016-11-17 |
| Evera MRI; S DR,VR;XT DR,VR, ICD; Intrinsic 30 ICD; Marquis VR ICD; Maximo II ICD; Protecta XT ICD; Secura ICD; Virtuoso (P980016/S600) | Medtronic Cardiac Rhythm Disease Management | 2016-11-17 |
| INTERSTIM THERAPY SYSTEM (BOWEL) (P080025/S125) | Medtronic Neuromodulation | 2016-11-17 |
| IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT (P120011/S003) | Bimini Health Tech | 2016-11-17 |
| Commander Delivery System (Including Loader) (P140031/S018) | Edwards Lifesciences, LLC | 2016-11-17 |
| DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES (P840064/S063) | Alcon Laboratories | 2016-11-17 |
| FREEZOR MAX CARDIAC CRYOABLATION CATHETER, AROTIC FRONT/AROTIC FRONT ADVANCE /AROTIC FRONT ADVANCE ST CARDIAC CRYOABLATI (P100010/S059) | Medtronic Cryocath, LP | 2016-11-17 |
| FREEZOR CARDIAC CRYOABLATION CATHETER /XTRA SUGICAL/ MAX SURGICAL CARDIA CRYOABLATION DEVICES, STERILE ACCESSORIES COAX (P020045/S077) | Medtronic Cryocath, LP | 2016-11-17 |
| Adapta, Versa, Sensia IPG; Advisa DR MRI IPG; EnPulse E1,E2 IPG; Kappa D (Kappa 700,900) IPG; Kappa DR (Kappa 650/700/60 (P980035/S474) | Medtronic, Inc. | 2016-11-17 |
| Implantable Spinal Fusion Stimulator's: SpF® -XL IIb 2/DM, SpF® -XL IIb 2/DW, SpF® PLUS-Mini (60?A/M), SpF® PLUS-Mini (6 (P850035/S043) | Ahp Eos Buyer, Inc. | 2016-11-17 |
| CURRENT AND FORTIFY FAMILY OF ICD DEVICES (P910023/S376) | ABBOTT MEDICAL | 2016-11-17 |
| Brava CRT-D; Brava Quad CRT-D; Concerto ICD,II CRT-D; Consulta CRT-D; InSync II Protect ICD; Maximo II CRT-D; Protecta X (P010031/S560) | Medtronic Cardiac Rhythm Disease Management | 2016-11-17 |
| PROMOTE, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA. (P030054/S313) | ABBOTT MEDICAL | 2016-11-17 |
| Consulta, Syncra, Viva CRT-P (P010015/S308) | Medtronic, Inc. | 2016-11-17 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S061) | ABBOTT MEDICAL | 2016-11-17 |
| INTERSTIM THERAPY SYSTEM (URINARY) (P970004/S230) | Medtronic Neuromodulation | 2016-11-17 |
| PRECISION SPECTRA, NOVI, MONTAGE MRI AND PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S263) | Boston Scientific Corp | 2016-11-16 |
| PRECISION NOVI MRI, SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S262) | Boston Scientific Corp | 2016-11-16 |
| DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S056) | Dexcom, Inc. | 2016-11-16 |
| CARDIOMEMS HF SYSTEM (P100045/S012) | ABBOTT MEDICAL | 2016-11-16 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S047) | Zimmer, Inc. | 2016-11-16 |
| NEUROPACE RNS SYSTEM (P100026/S044) | NeuroPace, Inc. | 2016-11-16 |
| H.E.L.P. Futura Apheresis System (P940016/S022) | B. Braun Avitum AG | 2016-11-15 |
| ESSURE SYSTEM (P020014/S046) | Bayer Pharma AG | 2016-11-15 |
| MiniMed 670G System (P160017/S001) | Medtronic Minimed, Inc. | 2016-11-15 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATETER (P130024/S014) | Lutonix | 2016-11-14 |
| IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM (P930016/S045) | Amo Manufacturing USA, LLC | 2016-11-14 |
| SEPRAFILM ADHESION BARRIER (P950034/S046) | Baxter Healthcare Corporation | 2016-11-14 |
| Evera MRI XT DR SureScan ICD DDMB1D1, Evera MRI XT VR SureScan ICD DVMB1D1, Evera MRI S DR SureScan ICD DDMC3D1, Evera M (P980016/S607) | Medtronic Cardiac Rhythm Disease Management | 2016-11-14 |
| Revo MRI SureScan IPG RVDR01 (P090013/S239) | Medtronic, Inc. | 2016-11-10 |
| INTERSTIM THERAPY SYSTEM (FOR BOWEL CONTROL) (P080025/S120) | Medtronic Neuromodulation | 2016-11-10 |
| MiniMed 670G Insulin Pump (P160017/S002) | Medtronic Minimed, Inc. | 2016-11-10 |
| ELECSYS ANTI-HCV II IMMUNOASSAY. (P140021/S007) | Roche Diagnostics Operations, Inc. | 2016-11-10 |
| Advisa DR IPG A4DR01, Advisa DR MRI IPG A2DR01, Advisa SR MRI IPG A3SR01 (P980035/S479) | Medtronic, Inc. | 2016-11-10 |
| ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, (P110029/S024) | Abbott Laboratories | 2016-11-10 |
| INTERSTIM THERAPY SYSTEM (FOR URINARY CONTROL) (P970004/S225) | Medtronic Neuromodulation | 2016-11-10 |
| EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S065) | Edwards Lifesciences, LLC | 2016-11-10 |
| CLOSER VASCULAR SEALING SYSTEM (P150022/S002) | Rex Medical, L.P. | 2016-11-10 |
| MINERVA ENDOMETRIAL ABLATION SYSTEM (P140013/S004) | Axora Medical, Inc. | 2016-11-09 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATETER (P130024/S013) | Lutonix | 2016-11-09 |
| TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S043) | Beckman Coulter, Inc. | 2016-11-09 |
| Oxford Partial Knee System - Bearing Components (P010014/S058) | Biomet Manufacturing Corp | 2016-11-09 |
| QVCAD SYSTEM (P150043) | Qview Medical, Inc. | 2016-11-09 |
| REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S040) | Smith & Nephew, Inc. | 2016-11-09 |
| SYNVISC (P940015/S037) | Sanofi Genzyme Corp. | 2016-11-08 |
| Enlite Sensor (P150001/S002) | Medtronic Minimed | 2016-11-08 |
| Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST (P110020/S016) | Roche Molecular Systems, Inc. | 2016-11-07 |
| IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT (P120011/S008) | Bimini Health Tech | 2016-11-07 |
| IsoFlex Optim Leads (P960030/S048) | ABBOTT MEDICAL | 2016-11-06 |