| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S080) | W. L. Gore & Associates, Inc. | 2016-02-01 |
| AMPLIA MRI/AMPLIA MRI QUAD CRT-D SURESCAN; COMPIA MRI/COMPIA MRI QUAD CRT-D SURESCAN (P010031/S513) | Medtronic Cardiac Rhythm Disease Management | 2016-02-01 |
| MINIMED 530G INSULIN PUMP (P120010/S074) | Medtronic, Inc. | 2016-02-01 |
| TACTICATH QUARTZ SET (P130026/S014) | St Jude Medical | 2016-02-01 |
| CAPSUREFIX MRI SURESCAN (P090013/S202) | Medtronic, Inc. | 2016-02-01 |
| SPRINT QUATTRO (P920015/S172) | Medtronic, Inc. | 2016-02-01 |
| CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS MONITOR (P890003/S338) | Medtronic, Inc. | 2016-02-01 |
| PARADIGM REAL-TIME INSULIN PUMP. PARADIGM REAL-TIME REVEL INSULIN PUMP. (P980022/S181) | Medtronic Minimed | 2016-02-01 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S069) | Cordis US Corporation | 2016-01-31 |
| ASSURITY AND ENDURITY CORE FAMILY OF PACEMAKERS (P880086/S267) | ABBOTT MEDICAL | 2016-01-30 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S006) | Lutonix | 2016-01-29 |
| HER2 CISH PHARMDX KIT (P100024/S008) | Dako Denmark A/S | 2016-01-29 |
| HER2 IQFISH PHARMDX (P040005/S012) | Agilent Technologies Singapore (International) Pte , Ltd. | 2016-01-29 |
| JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR (P040029/S002) | Euclid Vision Corporation | 2016-01-29 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S029) | Smith & Nephew, Inc. | 2016-01-28 |
| PROTEGO SD 60/16,PROTEGO SD 65/16,PROTEGO SD 75/18,PROTEGO S 60,PROTEGO S 65,PROTEGO S 75,PROTEGO T 65,PROTEGO TD 65/16, (P980023/S066) | Biotronik, Inc. | 2016-01-28 |
| COROX OTW 75 UP STEROID, COROX OTW 85 UP STEROID (P050023/S089) | Biotronik, Inc. | 2016-01-28 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S007) | Tandem Diabetes Care, Inc. | 2016-01-28 |
| REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S035) | Smith & Nephew, Inc. | 2016-01-28 |
| CELERITY 2D 75, CELERITY 2D 85,CELERITY 3D 75, CELERITY 3D 85, CELERITY PILOT 75, CELERITY PILOT 85, COROX OTW-L 75-BP, (P070008/S064) | Biotronik, Inc. | 2016-01-28 |
| SELOX SR 45,SELOX SR 53,SELOX SR 60,SELOX JT 45,SELOX JT 53,SELOX ST 53,SELOX ST 60,SETROX S 45,SETROX S 53,SETROX S 60, (P950037/S153) | Biotronik, Inc. | 2016-01-28 |
| SUPARTZ FX (P980044/S028) | Seikagaku Corp. | 2016-01-27 |
| THE MOBI-C CERVICAL DISC PROSTHESIS (P110009/S011) | Highridge Medical, LLC | 2016-01-27 |
| ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND (P120010/S082) | Medtronic, Inc. | 2016-01-27 |
| DISPOSABLE FALOPE-RING BAND APPLICATOR KITS (P870076/S019) | Gyrus Acmi, Inc. | 2016-01-27 |
| THE MOBI-C CERVICAL DISC PROSTHESIS (P110002/S011) | Highridge Medical, LLC | 2016-01-27 |
| BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA (P100025/S010) | Meridian Bioscience, Inc. | 2016-01-27 |
| FREEZOR CARDIAC CRYOABLATION SYSTEM (P020045/S072) | Medtronic Cryocath, LP | 2016-01-27 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S010) | Scott Laboratories, Inc. | 2016-01-26 |
| RESTYLANE/RESTYLANE-L/ PERLANE/ PERLANE-L , RESTYLANE SILK(INJECTABLE GELS) (P040024/S079) | Q-Med AB | 2016-01-26 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S042) | Neomend, Inc. | 2016-01-26 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S068) | Zoll Manufacturing Corporation | 2016-01-26 |
| COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY (P840062/S054) | Integra Lifesciences Corp. | 2016-01-26 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S003) | Edwards Lifesciences, LLC | 2016-01-26 |
| INTERSTIM THERAPY SYSTEM (P080025/S104) | Medtronic Neuromodulation | 2016-01-25 |
| SELECTSECURE LEAD (P030036/S083) | Medtronic Cardiac Rhythm Disease Management | 2016-01-25 |
| EVERA MRI ICD, EVERA S DR ICD, EVERA S VR ICD. EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA X (P980016/S564) | Medtronic Cardiac Rhythm Disease Management | 2016-01-25 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S067) | Medtronic, Inc. | 2016-01-25 |
| EPICARDIAL PATCH LEAD (P900061/S138) | Medtronic Cardiac Rhythm Disease Management | 2016-01-25 |
| ADAPTA, VERSA, SENSIA IPG, ADAPTA DR IPG, ADVISA DR MRI IPG, ADVISA DR MRI IPG, RELIA IPG, (P980035/S451) | Medtronic, Inc. | 2016-01-25 |
| ATTAIN STARFIX LEAD (P060039/S069) | Medtronic, Inc. | 2016-01-25 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S245) | Medtronic, Inc. | 2016-01-25 |
| ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD, CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S290) | Medtronic, Inc. | 2016-01-25 |
| ATTAIN ABILITY LEAD, ATTAIN PERFORMA LEAD, ATTAIN PERFORMA LEAD (P080006/S087) | Medtronic, Inc. | 2016-01-25 |
| CAPSURE SP NOVUS LEAD; CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD. (P850089/S116) | Medtronic Cardiac Rhythm Disease Management | 2016-01-25 |
| CAPSURE VDD 2 LEAD. VITATRON BRILLIANT S+ VDD LEAD, VITATRON BRILLIANT S+VDD LEAD (P890003/S348) | Medtronic, Inc. | 2016-01-25 |
| TRANSVENE CS/SVC LEAD (P980050/S103) | Medtronic, Inc. | 2016-01-25 |
| CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+LEAD (P830061/S126) | Medtronic Cardiac Rhythm Disease Management | 2016-01-25 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD, HV SPLITTER/ADAPTOR KIT (P920015/S170) | Medtronic, Inc. | 2016-01-25 |
| IMPELLA 2.5 SYSTEM (P140003/S007) | Abiomed, Inc. | 2016-01-25 |
| COREVALVE EVOLUT BIOPROSTHESIS, CORE VALVE BIOPROSTHESIS, ACCUTRAK DELIVERY CATHETER SYSTEM, GEN 3 & GEN4 COMPRESSION LO (P130021/S018) | Medtronic, Inc. | 2016-01-25 |
| INTERSTIM THERAPY SYSTEM (P970004/S209) | Medtronic Neuromodulation | 2016-01-25 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D , PROTECTA CRT-D, PROT (P010031/S525) | Medtronic Cardiac Rhythm Disease Management | 2016-01-25 |
| RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,RESUME,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION (P840001/S320) | Medtronic Neuromodulation | 2016-01-25 |
| CAPSUREFIX MRI LEAD, REVO MRI SURESCAN IPG (P090013/S213) | Medtronic, Inc. | 2016-01-25 |
| MYOCARDIAL PACING LEAD (P120017/S003) | Medtronic, Inc. | 2016-01-25 |
| CAPSUREFIX LEAD. CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITRATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE (P930039/S146) | Medtronic, Inc. | 2016-01-25 |
| PD-L1 IHC 28-8 pharmDx (P150027) | Dako North America, Inc. | 2016-01-23 |
| RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT (P140012/S003) | Boston Scientific Corporation | 2016-01-22 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S244) | Medtronic, Inc. | 2016-01-22 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S011) | Abbott Vascular (Idef Technologies Inc) | 2016-01-22 |
| RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULATI (P840001/S319) | Medtronic Neuromodulation | 2016-01-22 |
| MINIMED 530G INSULIN PUMP (P120010/S054) | Medtronic, Inc. | 2016-01-22 |
| PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S177) | Medtronic Minimed | 2016-01-22 |
| T:SLIM G4 INSULIN PUMP WITH DEXCON G4 PLATINUM CGM (P140015/S008) | Tandem Diabetes Care, Inc. | 2016-01-22 |
| MINIMED 530G SYSTEM, MINILINK REAL-TIME SYSTEM (P120010/S064) | Medtronic, Inc. | 2016-01-21 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P060040/S049) | ABBOTT MEDICAL | 2016-01-21 |
| SELECTSECURE LEAD (P030036/S084) | Medtronic Cardiac Rhythm Disease Management | 2016-01-21 |
| THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S061) | Thoratec Laboratories Corp. | 2016-01-21 |
| RF MARINR 5F SC, RF MARINR 5F SCXL, RF MARINR 5F SCXS, RF MARINR 5F SCXXL (P930029/S054) | Medtronic, Inc. | 2016-01-21 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE (P130005/S010) | Cardiovascular Systems, Inc. | 2016-01-21 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110009/S013) | Highridge Medical, LLC | 2016-01-21 |
| PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, MINILINK REAL-TIME SYSTEM, GUARDIAN REAL TIME SYSTEM (P980022/S179) | Medtronic Minimed | 2016-01-21 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION (P930039/S147) | Medtronic, Inc. | 2016-01-21 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110002/S013) | Highridge Medical, LLC | 2016-01-21 |
| ENLITE GLUCOSE SENSORS (P120010/S072) | Medtronic, Inc. | 2016-01-21 |
| CAPSUREFIX MRI LEAD (P090013/S214) | Medtronic, Inc. | 2016-01-21 |
| EPICARDIAL PATCH LEAD (P900061/S139) | Medtronic Cardiac Rhythm Disease Management | 2016-01-21 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT (P860003/S082) | Therakos Development Limited | 2016-01-21 |
| VISTAKON(SENOFILCON A) BRAND CONTACT LENSES (P040045/S054) | Vistakon, Division of Johnson & Johnson Vision Car | 2016-01-20 |
| RADIESSE INJECTABLE IMPLANT (P050052/S081) | Merz North America, Inc. | 2016-01-20 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S021) | LeMaitre Vascular, Inc. | 2016-01-19 |
| SPRINT QUATTRO SECURE S MRI SURESCAN LEAD, SPRINT QUATTRO SECURE MRI SURESCAN LEAD (P920015/S164) | Medtronic, Inc. | 2016-01-19 |
| VISIA AF VR , S VR, AFMRI VR SURESCAN, PROGRAMMER SOFTWARE, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980016/S551) | Medtronic Cardiac Rhythm Disease Management | 2016-01-19 |
| CARELINK MONITOR , CARDIOSIGHT READER, CARELINK EXPRESS MONITOR (P890003/S339) | Medtronic, Inc. | 2016-01-19 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S071) | Medtronic | 2016-01-15 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S244) | Boston Scientific Corp | 2016-01-15 |
| LOTRAFILCON A & B SOFT CONTACT LENSES (P010019/S043) | Alcon Laboratories, Inc. | 2016-01-15 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S064) | Medtronic | 2016-01-15 |
| ADATO SIL-OL 5000 SILICONE OIL (P910071/S016) | Bausch & Lomb | 2016-01-15 |
| COCHLEAR IMPLANT SYSTEM (P970051/S139) | Cochlear Americas | 2016-01-15 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM (P060037/S043) | Zimmer, Inc. | 2016-01-15 |
| RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S001) | Boston Scientific Corporation | 2016-01-14 |
| BIOMET EBI BONE HEALING SYSTEM (P790002/S034) | Ahp Eos Buyer, Inc. | 2016-01-14 |
| DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINIOUS GLUCOSE MONITORING SYSTEM (P120005/S043) | Dexcom, Inc. | 2016-01-14 |
| FREEZOR CARDIAC CRYOABLATION SYSTEM (P020045/S071) | Medtronic Cryocath, LP | 2016-01-14 |
| SPF IMPLANTABLE SPINAL FUSION STIMULATORS (P850035/S041) | Ahp Eos Buyer, Inc. | 2016-01-14 |
| SEPRAFILM ADHESION BARRIER (P950034/S045) | Baxter Healthcare Corporation | 2016-01-14 |
| BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM (P850022/S027) | Ahp Eos Buyer, Inc. | 2016-01-14 |
| ENLITE GLUCOSE SENSOR (P120010/S081) | Medtronic, Inc. | 2016-01-14 |