| DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S055) | Dexcom, Inc. | 2016-12-09 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S086) | Medtronic, Ireland | 2016-12-09 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S067) | Medtronic Vascular | 2016-12-09 |
| Restylane Refyne, Restylane Defyne (P140029) | Q-Med AB | 2016-12-09 |
| AMS 700 INFLATABLE PENILE PROSTHESES WITH INHIBIIZONE TREATMENT; AMBICOR INFLATABLE PENILE PROSTHESES (N970012/S118) | Boston Scientific Corp | 2016-12-09 |
| PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S094) | Abbott Vascular, Inc. | 2016-12-08 |
| BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM (P850022/S028) | Ahp Eos Buyer, Inc. | 2016-12-08 |
| MED-EL EAS EXTENDED COCHLEAR IMPLANT SYSTEM (P000025/S092) | Med-El Corp. | 2016-12-08 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S057) | Cook, Inc. | 2016-12-08 |
| REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S041) | Smith & Nephew, Inc. | 2016-12-08 |
| Artificial Pancreas Device System, Threshold Suspend (P120010/S091) | Medtronic, Inc. | 2016-12-08 |
| BIOMET EBI BONE HEALING SYSTEM (P790002/S036) | Ahp Eos Buyer, Inc. | 2016-12-08 |
| Sensor-Enabled Pump System-Continuous Glucose Monitoring System (P150019/S016) | Medtronic Minimed | 2016-12-08 |
| PRECISE NITINOL STENT SYSTEM (P030047/S033) | Cordis US Corporation | 2016-12-08 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S135) | Boston Scientific Corp | 2016-12-07 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S037) | Allergan | 2016-12-07 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MO & OTW (P150003/S015) | Boston Scientific Corporation | 2016-12-07 |
| IMPELLA CP Systems (P140003/S012) | Abiomed, Inc. | 2016-12-07 |
| HELISTAT HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S073) | Integra LifeSciences Corporation | 2016-12-07 |
| MEDTRONIC ATTAIN ABILITY, MRI SURESCAN AND ATTAIN PERFORMA MRI SURESCAN (P080006/S102) | Medtronic, Inc. | 2016-12-07 |
| NATRELLE HIGHLY COHESIVE ANATOMICALLY SILICONE-FILLED BREAST IMPLANTS (P040046/S018) | Allergan | 2016-12-07 |
| COLLASTAT INSTAT ABSORABLE COLLAGEN HOMESTATIC AGENTS (P810006/S074) | Integra LifeSciences Corporation | 2016-12-07 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S025) | Boston Scientific Corporation | 2016-12-07 |
| NATRELLE SALINE- FILLED BREAST IMPLANTS (P990074/S035) | Allergan | 2016-12-07 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S127) | Boston Scientific Corp | 2016-12-07 |
| INGEVITY (P150012/S019) | Boston Scientific | 2016-12-07 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S032) | Boston Scientific Corp | 2016-12-07 |
| PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S268) | Boston Scientific Corp | 2016-12-06 |
| PRECISION SPECTRA, PRECISION MONTAGE AND PRECISION MONTAGE MRI SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S267) | Boston Scientific Corp | 2016-12-06 |
| LEAD EXTENSION, PERCUTANEOUS EXTENSION KIT, LEADS (P970004/S152) | Medtronic Neuromodulation | 2016-12-06 |
| Application Software for Micra Transcatheter Pacing System MC1VR01 (P150033/S009) | Medtronic, Inc. | 2016-12-06 |
| IntellaNav XP, IntellaNav MiFi XP Ablation Catheters (P020025/S092) | Boston Scientific | 2016-12-06 |
| NEUROPACE RNS SYSTEM (P100026/S045) | NeuroPace, Inc. | 2016-12-06 |
| DBS LEAD, DBS LEAD-REDUCED SPACING (P960009/S167) | Medtronic, Inc. | 2016-12-06 |
| NCP Model 201 Programming Wand, VNS Therapy AspireHC Model 105 Generator, VNS Therapy AspireSR, Model 106 Generator (P970003/S206) | LivaNova USA, Inc. | 2016-12-06 |
| CHILLI II ABLATION CATHETER. (P980003/S071) | Boston Scientific Corp | 2016-12-06 |
| Blazer OI & IntellaNav OI Ablation Catheters (P150005/S012) | Boston Scientific Corp | 2016-12-06 |
| LEAD EXTENSION, PERCUTANEOUS EXTENSION KIT AND LEAD (P080025/S048) | Medtronic Neuromodulation | 2016-12-06 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S026) | Medtronic, Inc. | 2016-12-06 |
| PERCUTANEOUS EXTENSION KIT (P840001/S236) | Medtronic Neuromodulation | 2016-12-06 |
| GLAUKOS ISTENT TRABECULAR MICRO BYPASS STENT SYSTEM (P080030/S019) | Glaukos Corporation | 2016-12-05 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S013) | Inspire Medical Systems | 2016-12-05 |
| SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S076) | Johnson & Johnson Surgical Vision, Inc. | 2016-12-05 |
| MINIMED 630G SYSTEM WITH SMARTGUARD (P150001/S004) | Medtronic Minimed | 2016-12-02 |
| SIENTRA SILICONE GEL BREAST IMPLANTS (P070004/S008) | Tiger Aesthetics Medical, LLC | 2016-12-02 |
| IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S002) | Medtronic Minimed | 2016-12-02 |
| MINIMED 530G SYSTEM (P120010/S097) | Medtronic, Inc. | 2016-12-02 |
| Spinal-Stim (P850007/S035) | Orthofix, Inc. | 2016-12-02 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S023) | Medtronic Minimed | 2016-12-02 |
| FILSHIE CLIP(MARK VI) SYSTEM (P920046/S008) | Femcare , Ltd. | 2016-12-02 |
| Cervical-Stim (P030034/S009) | Orthofix, Inc. | 2016-12-02 |
| MiniMed 670G System (P160017/S005) | Medtronic Minimed, Inc. | 2016-12-02 |
| Edwards Certitude Delivery System (P140031/S024) | Edwards Lifesciences, LLC | 2016-12-02 |
| BD SUREPATH COLLECTION VIAL (P970018/S033) | Bd Diagnostic Systems | 2016-12-02 |
| PD-L1 IHC 28-8 PHARMDX (Non-Squamous Indication) (P150025/S002) | Agilent Technologies, Inc. | 2016-12-01 |
| PALMAZ BALLOON EXPANDABLE STENT (P890017/S019) | Cordis US Corporation | 2016-12-01 |
| COLOGUARD (P130017/S013) | Exact Sciences Corporation | 2016-12-01 |
| VENASEAL CLOSURE SYSTEM (P140018/S005) | Medtronic Vascular, Inc. | 2016-12-01 |
| IMPELLA VENTRICULAR SUPPORT SYSTEM (P140003/S008) | Abiomed, Inc. | 2016-12-01 |
| WOLVERINE CORONARY CUTTING BALLOON MONORAIL (MR) AND OVER-THE WIRE (OTW) (P950020/S077) | Boston Scientific Corp | 2016-12-01 |
| Wolverine Coronary Cutting Balloon (Monorail) (P950020/S076) | Boston Scientific Corp | 2016-12-01 |
| OPEN PIVOT MECHANICAL HEART VALVES AND OPEN PIVOT AORTIC VALVED GRAFT (P990046/S048) | Medtronic Ats Medical, Inc. | 2016-12-01 |
| AngioJet Ultra Thrombectomy System Console (P980037/S061) | Boston Scientific Corp | 2016-12-01 |
| AMS 700 SERIES INFLATABLE PENILE PROSTHESES (N970012/S124) | Boston Scientific Corp | 2016-12-01 |
| SJM Master Series Mechanical Heart Valve with Silzone Coating, Expanded Polyester Cuff with Silzone Coating, HP Cuff wit (P810002/S098) | ABBOTT MEDICAL | 2016-12-01 |
| HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S063) | ABBOTT MEDICAL | 2016-12-01 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM, ANGIOJET ULTRA DISTAFLEX THROMBECTOMY SET (P980037/S060) | Boston Scientific Corp | 2016-12-01 |
| PD-L1 IHC 22C3 PHARMDX (P150013/S003) | Agilent Technologies, Inc. | 2016-12-01 |
| EON MINI, PRODIGY AND BRIO CHARGING SYSTEMS (P010032/S126) | ABBOTT MEDICAL | 2016-12-01 |
| BRIO NEUROSTIMULATION SYSTEM (P140009/S021) | ABBOTT MEDICAL | 2016-12-01 |
| PD-L1 IHC 28-8 PHARMDX (Melanoma Indication) (P150027/S002) | Dako North America, Inc. | 2016-12-01 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S034) | W. L. Gore & Associates, Inc. | 2016-12-01 |
| Innova Vascular Self-Expanding Stent With Delivery System (P140028/S020) | Boston Scientific Corporation | 2016-12-01 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S073) | Boston Scientific Corp | 2016-12-01 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S095) | W. L. Gore & Associates, Inc. | 2016-12-01 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S018) | Boston Scientific | 2016-11-30 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S028) | Ortho-Clinical Diagnostics, Inc. | 2016-11-30 |
| LifeVest Wearable Defibrillator (P010030/S081) | Zoll Manufacturing Corporation | 2016-11-30 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S025) | Ventana Medical Systems, Inc. | 2016-11-30 |
| PERLANE (P040024/S094) | Q-Med AB | 2016-11-30 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S013) | ABBOTT MEDICAL | 2016-11-30 |
| VALITUDE, VALITUDE X4 (P030005/S146) | Guidant Corp. | 2016-11-30 |
| coflex® Interlaminar Technology (P110008/S006) | Companion Spine France | 2016-11-30 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 (N970003/S198) | Boston Scientific Corp | 2016-11-30 |
| EMBLEM MRI S-CD Pulse Generator (PG) Model A219, EMBLEM S-CD Pulse Generator (PG) Model A209 (P110042/S069) | Boston Scientific Corporation | 2016-11-29 |
| INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S023) | Boston Scientific Corporation | 2016-11-29 |
| TRIDYNE VASCULAR SEALANT (P150016/S003) | Neomend, Inc. | 2016-11-29 |
| GORE VIATORR TIPS (P040027/S052) | W. L. Gore & Associates, Inc. | 2016-11-29 |
| HiResolution Bionic Ear System (P960058/S119) | Advanced Bionics | 2016-11-29 |
| AMS 700 SERIES INFLATABLE PENILE PROSTHESIS (IPP) WITH AND WITHOUT INHIBIZONE TREATMENT (N970012/S120) | Boston Scientific Corp | 2016-11-29 |
| LCS(R) TOTAL KNEE SYSTEM (P830055/S178) | Depuy, Inc. | 2016-11-28 |
| Activa Deep Brain Stimulation Therapy System (P960009/S264) | Medtronic, Inc. | 2016-11-28 |
| DEEP BRAIN STIMULATION (DBS) EXTERNAL PROGRAMMER APPS (P140009/S015) | ABBOTT MEDICAL | 2016-11-28 |
| SPINAL CORD STIMULATION (SCS) EXTERNAL PROGRAMMER APPS (P010032/S118) | ABBOTT MEDICAL | 2016-11-28 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Leads (P840001/S345) | Medtronic Neuromodulation | 2016-11-28 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S043) | DePuy Orthopaedics, Inc. | 2016-11-28 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S086) | Medtronic | 2016-11-28 |
| PROCLAIM DORSAL ROOT GANGLION (DRG) NEUROSTIMULATION SYSTEM (P150004/S002) | ABBOTT MEDICAL | 2016-11-28 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023/S022) | Medtronic Vascular, Inc. | 2016-11-25 |
| PRECISION MONTAGE MRI AND SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S265) | Boston Scientific Corp | 2016-11-24 |