| Healon Ultimate Dual Pack, HEALON, HEALON GV, HEALON5, and Healon Duet Dual Pack products (P810031/S058) | Johnson & Johnson Surgical Vision, Inc. | 2016-10-07 |
| COLLASTAT (P810006/S071) | Integra LifeSciences Corporation | 2016-10-07 |
| ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM (P150023/S001) | Abbott Vascular, Inc. | 2016-10-07 |
| IN PACT ADMIRAL PACLITAXEL-COATED BALLOON CATHETER (P140010/S025) | Medtronic, Inc. | 2016-10-07 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S057) | Vistakon, Division of Johnson & Johnson Vision Car | 2016-10-07 |
| NATRELLE SALINE BREAST IMPLANTS (P990074/S033) | Allergan | 2016-10-07 |
| FlexAbility Ablation Catheter (Bi-Directional) (P110016/S036) | ABBOTT MEDICAL | 2016-10-07 |
| CapSureFix Novus Lead; Vitatron Crystalline; Active Fixation Lead (P930039/S159) | Medtronic, Inc. | 2016-10-06 |
| KONING BREAST CT (MODEL CBCT 1000) (P130025/S002) | Koning Corporation | 2016-10-06 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S046) | Best Vascular, Inc. | 2016-10-06 |
| COLLACOTE(TM) (P840062/S056) | Integra Lifesciences Corp. | 2016-10-06 |
| Attain Ability, Performa Lead 4298, (P080006/S099) | Medtronic, Inc. | 2016-10-06 |
| Attain Bipolar OTW Lead (P010015/S309) | Medtronic, Inc. | 2016-10-06 |
| HV splitter/adaptor kit; Sprint Quattro Lead (P920015/S184) | Medtronic, Inc. | 2016-10-06 |
| ATTAIN STARFIX MODEL 4195 LEAD (P060039/S073) | Medtronic, Inc. | 2016-10-06 |
| CapSure Sense, SP Novus Lead: Vitatron Crystalline, Excellence PS+ Lead; (P830061/S135) | Medtronic Cardiac Rhythm Disease Management | 2016-10-06 |
| AUGMENT BONE GRAFT (P100006/S003) | Biomimetic Therapeutics, LLC | 2016-10-06 |
| PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S259) | Boston Scientific Corp | 2016-10-06 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S015) | Abbott Vascular (Idef Technologies Inc) | 2016-10-06 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S008) | AtriCure, Inc. | 2016-10-05 |
| PD-L1 IHC 28-8 PHARMDX (NON-SQUAMOUS NSCLC INDICATION) (P150025/S001) | Agilent Technologies, Inc. | 2016-10-05 |
| PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S258) | Boston Scientific Corp | 2016-10-05 |
| D-Stat Flowable hemostat (P990037/S034) | Vascular Solutions, Inc. | 2016-10-05 |
| GORE TIGRIS VASCULAR STENT (P160004/S001) | W. L. Gore & Associates, Inc. | 2016-10-05 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S050) | W. L. Gore & Associates, Inc. | 2016-10-05 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (P060040/S058) | ABBOTT MEDICAL | 2016-10-05 |
| BIOFINITY ENERGY ASPHERE (P080011/S046) | CooperVision, Inc. | 2016-10-05 |
| PD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION) (P150027/S001) | Dako North America, Inc. | 2016-10-05 |
| TECNIS 1-Piece Multifocal IOLs; TECNIS Symfony Extended Range of Vision (EVR) IOL., TECNIS Symfony Toric ERV IOLs (P980040/S074) | Johnson & Johnson Surgical Vision, Inc. | 2016-10-04 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM (P140015/S011) | Tandem Diabetes Care, Inc. | 2016-10-04 |
| Amplia, Brava, Compia, Concerto II. Consulta, Maximo II, Protecta, Protecta XT, Viva S,XT, Quad CRT-D (P010031/S561) | Medtronic Cardiac Rhythm Disease Management | 2016-10-04 |
| REFLECTION CERAMIC Acetabular Hip SYSTEM (RCHS) (P030022/S037) | Smith & Nephew, Inc. | 2016-10-04 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S012) | Tandem Diabetes Care, Inc. | 2016-10-04 |
| MONOVISC (P090031/S007) | Anika Therapeutics, Inc. | 2016-10-04 |
| REPLY/ESPRIT PACEMAKER IMPLANTABLE DEVICES (P980049/S118) | MicroPort CRM USA, Inc. | 2016-10-04 |
| EON MINI LE CHARGING SYSTEM AND PRODIGY CHARGER SYSTEM (P010032/S122) | ABBOTT MEDICAL | 2016-10-04 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025/S092) | Medtronic Neuromodulation | 2016-10-04 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P970004/S197) | Medtronic Neuromodulation | 2016-10-04 |
| Essentio, Proponent and Accolade MRI Pacemakers (P150012/S013) | Boston Scientific | 2016-10-04 |
| Evera S, Maximo II, Protecta, Secura,Quad XT CRT-D; Virtuoso II, Visia AF, MRI VR ICD, (P980016/S601) | Medtronic Cardiac Rhythm Disease Management | 2016-10-04 |
| BRIO LE CHARGING SYSTEM (P140009/S019) | ABBOTT MEDICAL | 2016-10-04 |
| Permanent defibrillator electrodes (P980023/S078) | Biotronik, Inc. | 2016-10-03 |
| INFINITY FAMILY OF DBS IPGS AND DBS EPG (P140009/S010) | ABBOTT MEDICAL | 2016-10-03 |
| JUVEDERM VOLBELLA XC (P110033/S022) | Allergan | 2016-10-03 |
| PROTEGE,PRODIGY,PROCLAIM ELITE FAMILY OF SCS IPGS AND SCS EPG (P010032/S109) | ABBOTT MEDICAL | 2016-10-03 |
| MiniMed 630G Pump (P150001/S001) | Medtronic Minimed | 2016-09-30 |
| GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S018) | Glaukos Corporation | 2016-09-30 |
| ADVANTIO; INGENIO; VITALIO; FORMIO; ESSENTIO; PROPONENT; ACCOLADE; ALTRUA 2 PACEMAKERS. (N970003/S194) | Boston Scientific Corp | 2016-09-29 |
| Patient Cable (P820003/S136) | Medtronic Cardiac Rhythm Disease Management | 2016-09-29 |
| UROVYSION BLADDER CANCER KIT (P030052/S018) | Abbott Molecular | 2016-09-29 |
| Essure System for Permanent Birth Control (Model ESS305) (P020014/S047) | Bayer Pharma AG | 2016-09-29 |
| ORIGEN; INOGEN; DYNAGEN; PUNCTUA; ENERGEN; INCEPTA CRT-Ds (P010012/S432) | Boston Scientific Corp | 2016-09-29 |
| EXABLATE NEURO THALAMOTOMY (P150038/S001) | Insightec | 2016-09-29 |
| Patient Magnet (P900061/S141) | Medtronic Cardiac Rhythm Disease Management | 2016-09-29 |
| RF ENHANCR II (P930029/S055) | Medtronic, Inc. | 2016-09-29 |
| ORIGEN; INOGEN; DYNAGEN; PUNCTUA; ENERGEN; INCEPTA ICDS (P960040/S380) | Boston Scientific | 2016-09-29 |
| PATHVYSION HER-2 DNA PROBE KIT (P980024/S015) | Abbott Molecular, Inc. | 2016-09-29 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S133) | Boston Scientific Corp | 2016-09-29 |
| EMBLEM; EMBLEM MRI (S-ICD) (P110042/S063) | Boston Scientific Corporation | 2016-09-29 |
| ESSENTIO MRI; PROPONENT MRI; ACCOLADE MRI Pacemakers (P150012/S015) | Boston Scientific | 2016-09-29 |
| Patient Magnet (P980016/S599) | Medtronic Cardiac Rhythm Disease Management | 2016-09-29 |
| VALITUDE; INVIVE CRT-Ps (P030005/S142) | Guidant Corp. | 2016-09-29 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S020) | Boston Scientific Corporation | 2016-09-29 |
| OVATION ABDOMINAL STENT GRAFT SYSTEM (P120006/S024) | Endologix, LLC | 2016-09-29 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S011) | Abbott Molecular, Inc. | 2016-09-29 |
| Analyzer Adaptors, Cable, Patient Cable; ECG Cable, Output Adaptor (P890003/S364) | Medtronic, Inc. | 2016-09-29 |
| Precision Spectra & Novi Spinal Cord Stimulator (SCS) Systems; Precision Montage MRI and Precision Montage Spinal Cord S (P030017/S257) | Boston Scientific Corp | 2016-09-29 |
| ENDOTAK RELIANCE 4-SITE, Defibrillation Lead Family ,Active Fixation Models (New): 0272, 0273. Passive Fixation Models ( (P910073/S138) | Boston Scientific | 2016-09-29 |
| HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S060) | ABBOTT MEDICAL | 2016-09-29 |
| INFUSE BONE GRAFT; CLYDESDALE SPINAL SYSTEM (P000058/S062) | Medtronic Sofamor Danek USA, Inc. | 2016-09-29 |
| CARTIVA SYNTHETIC CARTILAGE IMPLANT DEVICE (P150017/S002) | Cartiva, Inc. | 2016-09-29 |
| LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S029) | Lenstec, Inc. | 2016-09-28 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S020) | Exactech, Inc. | 2016-09-28 |
| ATTAIN ABILITY LEAD; ATTAIN PERFORMA LEAD (P080006/S098) | Medtronic, Inc. | 2016-09-28 |
| CAPSURE SENSE LEAD; CAPSURE SP NOVUS LEAD; VITATRON CYRSTALLINE LEAD; VITATRON EXCELLENCE PS+ LEAD (P830061/S134) | Medtronic Cardiac Rhythm Disease Management | 2016-09-28 |
| SPRINT QUATTRO/SUBCUTANEOUS/TRANSVENE CS/SVC LEADS (P920015/S183) | Medtronic, Inc. | 2016-09-28 |
| CAPSURE VDD 2 LEAD, VITATRON BRILLIANT S+ VVD LEAD (P890003/S363) | Medtronic, Inc. | 2016-09-28 |
| TRANSVENE CS/SVC LEAD (P980050/S106) | Medtronic, Inc. | 2016-09-28 |
| INTEGRITY CORONARY STENT SYSTEM (P030009/S090) | Medtronic, Ireland | 2016-09-28 |
| PALMAZ BALLOON EXPANDABLE STENT (P890017/S018) | Cordis US Corporation | 2016-09-28 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S076) | Medtronic Vascular | 2016-09-28 |
| ATTAIN BIPOLAR OTW AND OTW LV LEAD (P010015/S307) | Medtronic, Inc. | 2016-09-28 |
| SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R. ANKLE) (P050050/S010) | Djo Global | 2016-09-28 |
| CAPSUREFIX MRI LEAD (P090013/S234) | Medtronic, Inc. | 2016-09-28 |
| ATTAIN STARFIX LEAD (P060039/S072) | Medtronic, Inc. | 2016-09-28 |
| MiniMed 670G System (P160017) | Medtronic Minimed, Inc. | 2016-09-28 |
| CAPSURE SP NOVUS/CAPSURE SP Z/CAPSURE Z NOVUS LEADS, VITATRON IMPULSE II LEAD (P850089/S119) | Medtronic Cardiac Rhythm Disease Management | 2016-09-28 |
| ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (P000037/S047) | On-X Life Technologies, Inc. | 2016-09-28 |
| SURGICEL Family of ABSORBABLE HEMOSTAT (N12159/S040) | ETHICON, Inc. | 2016-09-28 |
| CAPSUREFIX,CAPSUREFIX NOVUS, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S158) | Medtronic, Inc. | 2016-09-28 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces Specify, and Vectris Spinal Cord Stimulation Lead (P840001/S343) | Medtronic Neuromodulation | 2016-09-28 |
| cobas EGFR MUTATION TEST v2 (P150044) | Roche Molecular Systems, Inc. | 2016-09-28 |
| GEL-ONE(R) (P080020/S020) | Seikagaku Corp. | 2016-09-27 |
| Platinum VR/DR ICDS,Paradym RF VR/ RF DR CRT-Ds, Intensia VR, Intensia DR (P980049/S117) | MicroPort CRM USA, Inc. | 2016-09-27 |
| ASCENDA INTRATHECAL CATHETERS AND KITS (P860004/S257) | Medtronic, Inc. | 2016-09-27 |
| Platinium, Paradym RF, RF VR, RF DR, Intensia CRT-Ds (P060027/S083) | MicroPort CRM USA, Inc. | 2016-09-27 |
| HER2 CISH PHARMDX KIT (P100024/S010) | Dako Denmark A/S | 2016-09-27 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S004) | Boston Scientific Corp | 2016-09-27 |
| Allure, Allure Quadra, Quadra Allure MP (P030035/S149) | ABBOTT MEDICAL | 2016-09-27 |
| GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S024) | ETHICON, Inc. | 2016-09-27 |