| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S042) | Abbott Vascular | 2013-03-22 |
| ARCTIC FRONT CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CRYOABLATION CATHETER (P100010/S023) | Medtronic Cryocath, LP | 2013-03-21 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S103) | Cochlear Americas | 2013-03-21 |
| ARISTA AH ABSORBABLE HEMOSTAT PARTICLES (P050038/S015) | Davol, Inc. | 2013-03-21 |
| BELOTERO BALANCE, BELOTERO BALANCE (SAMPLE) (P090016/S006) | Merz North America, Inc. | 2013-03-21 |
| GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S007) | Glaukos Corporation | 2013-03-21 |
| DURASPHERE INECTABLE BULKING AGENT (P980053/S014) | Carbon Medical Technologies, Inc. | 2013-03-21 |
| FEMSOFT URETHRAL INSERT (P990002/S002) | Rochester Medical Corp. | 2013-03-21 |
| COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S005) | Roche Molecular Systems, Inc. | 2013-03-21 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S009) | OraSure Technologies, Inc. | 2013-03-21 |
| PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S005) | Ventana Medical Systems, Inc. | 2013-03-20 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S399) | Medtronic Cardiac Rhythm Disease Management | 2013-03-20 |
| PATHWAY ANTI-HER2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S015) | Ventana Medical Systems, Inc. | 2013-03-20 |
| REPLY/ESPRIT SR/DR PACEMAKERS (P950029/S077) | MicroPort CRM USA, Inc. | 2013-03-20 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT (P860003/S072) | Therakos Development Limited | 2013-03-20 |
| ADAPTA VERSA, SENSIA IPG, RELIA IPG (P980035/S310) | Medtronic, Inc. | 2013-03-20 |
| SOF-SENSOR GLUCOSE SENSOR (P980022/S126) | Medtronic Minimed | 2013-03-20 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S362) | Medtronic Cardiac Rhythm Disease Management | 2013-03-20 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S191) | Medtronic, Inc. | 2013-03-20 |
| ADVISA DR IPG, ADVISA MRI IPG (P980035/S309) | Medtronic, Inc. | 2013-03-20 |
| SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM (P840001/S219) | Medtronic Neuromodulation | 2013-03-20 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO DR/VR ICD (P980016/S397) | Medtronic Cardiac Rhythm Disease Management | 2013-03-20 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S360) | Medtronic Cardiac Rhythm Disease Management | 2013-03-20 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S189) | Medtronic, Inc. | 2013-03-20 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S010) | OraSure Technologies, Inc. | 2013-03-19 |
| VARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC. (P950037/S116) | Biotronik, Inc. | 2013-03-18 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO ICD, VIRTUOSO II DR/VR ICD (P980016/S360) | Medtronic Cardiac Rhythm Disease Management | 2013-03-18 |
| CONCERTO ICD, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S313) | Medtronic Cardiac Rhythm Disease Management | 2013-03-18 |
| BELOS & LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S051) | Biotronik, Inc. | 2013-03-18 |
| STRATOS LV/LV-T, EVIA AND ENTOVIS HF/HF-T CRT-P'S (P070008/S036) | Biotronik, Inc. | 2013-03-18 |
| ILESTO 7/ 5 VR-T ICD, IFORIA 7/ 5 VR-T ICD, ILESTO 7/ 5 VR-T DX ICD, ILFORIA 7/ 5 VR-T DX ICD, ILESTO 7/ 5 DR-T ICD (P050023/S058) | Biotronik, Inc. | 2013-03-18 |
| INSIGHTEC EXABLATE SYSTEM (P110039/S002) | Insightec | 2013-03-15 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S029) | Bard Peripheral Vascular | 2013-03-15 |
| LCS TOTAL KNEE SYSTEM (P830055/S130) | Depuy, Inc. | 2013-03-15 |
| INSIGHTEC EXABLATE SYSTEM (P110039/S001) | Insightec | 2013-03-15 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S001) | Globus Medical, Inc. | 2013-03-15 |
| CERVISTA HPV HR ASSAY (P080014/S016) | Hologic, Inc. | 2013-03-15 |
| EON MINI IMPLANTABLE PULSE GENERATOR (P010032/S066) | ABBOTT MEDICAL | 2013-03-15 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S155) | Boston Scientific Corp | 2013-03-15 |
| APLIGRAF (P950032/S071) | Organogenesis, Inc. | 2013-03-14 |
| REPLY/ESPRIT PACEMAKER FAMILY (P950029/S076) | MicroPort CRM USA, Inc. | 2013-03-14 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S040) | CooperSurgical, Inc. | 2013-03-14 |
| CONSULTA CRT-P, ADVISA (MODEL 9995 V8.0) CONSULTA CRT-D, SECURA (MODEL 9995 V8.0) INSYNC III, MAXIMO II, CONCERTO II (P010031/S319) | Medtronic Cardiac Rhythm Disease Management | 2013-03-13 |
| ARCHITECT CORE-M (P060035/S020) | Abbott Laboratories | 2013-03-13 |
| ARCHITECT CORE-M (P060035/S019) | Abbott Laboratories | 2013-03-13 |
| ARCHITECT TOTAL PSA (P910007/S039) | Abbott Laboratories | 2013-03-13 |
| ARCHITECT CORE (P080023/S020) | Abbott Laboratories | 2013-03-13 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD (P980016/S396) | Medtronic Cardiac Rhythm Disease Management | 2013-03-13 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S039) | Medtronic, Inc. | 2013-03-13 |
| INSYNC III (MODEL 9981 V8.0) (P010015/S166) | Medtronic, Inc. | 2013-03-13 |
| CONSULTA DF4 ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S359) | Medtronic Cardiac Rhythm Disease Management | 2013-03-13 |
| KAPPA 900 (MODEL 9988 V8.0). ADAPTA, VERSA, SENSIA (MODEL SW003 V8.0), RELIA (MODEL SW010 V8.0), ENPULSE (MODEL 9981 V8. (P980035/S280) | Medtronic, Inc. | 2013-03-13 |
| EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S016) | Ferring Pharmaceuticals, Inc. | 2013-03-13 |
| BV1 1% OVD (1% SODIUM HYALURONATE VISCCOELASTIC SURGICAL AID FLUID) (P960011/S022) | Altacor , Ltd. | 2013-03-13 |
| REPLY AND ESPIRIT FAMILY OF PACEMAKERS (P950029/S075) | MicroPort CRM USA, Inc. | 2013-03-13 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S039) | Medtronic, Inc. | 2013-03-13 |
| ARCHITECT FREE PSA (P980007/S030) | Abbott Laboratories | 2013-03-13 |
| HANCOCK LOW POROSITY AND MOFIFIED ORIFICE VALVED CONDUIT (P790007/S035) | Medtronic Heart Valves | 2013-03-13 |
| DEVICE CARELINK ENCORE 29901 PROGRAMMER INCLUDING ACCESSORIES AND REVEAL DX, REVEAL XT (MODEL SW007 V8.0) (P890003/S254) | Medtronic, Inc. | 2013-03-13 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S047) | Medtronic, Inc. | 2013-03-13 |
| ARCHITECT CORE (P080023/S021) | Abbott Laboratories | 2013-03-13 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S100) | Cochlear Americas | 2013-03-13 |
| VIDAS TOTAL PSA (P040008/S006) | bioMerieux, Inc. | 2013-03-13 |
| LATITUDE COMMUNICATOR (P910077/S132) | Boston Scientific | 2013-03-13 |
| ARCHITECT AFP (P120008/S001) | Abbott Laboratories | 2013-03-13 |
| ISERT GEMETRIC (P080004/S013) | Hoya Surgical Optics, Inc. | 2013-03-13 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S026) | Abbott Laboratories | 2013-03-13 |
| ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S011) | Abbott Laboratories | 2013-03-13 |
| ARCHITECT AUSAB (P050051/S020) | Abbott Laboratories, Inc. | 2013-03-13 |
| VISTATRON C&T SERIES (MODEL VSF04 V8.0, MODEL VSF 12 V8.0, MODEL VSF08 V8.0) (P990001/S105) | Medtronic, Inc. | 2013-03-13 |
| ARCHITECT ANTI-HCV (P050042/S023) | Abbott Laboratories, Inc. | 2013-03-13 |
| CONCERTO, VIRTUOSO (MODEL SW002 V8.0) (P980016/S366) | Medtronic Cardiac Rhythm Disease Management | 2013-03-13 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S101) | Cochlear Americas | 2013-03-13 |
| ARCHITECT ANTI-HCV (P050042/S022) | Abbott Laboratories, Inc. | 2013-03-13 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S057) | Edwards Lifesciences, LLC | 2013-03-12 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S008) | Edwards Lifesciences, LLC | 2013-03-12 |
| REPLY/ESPRIT SR/DR PACEMAKERS (P950029/S074) | MicroPort CRM USA, Inc. | 2013-03-12 |
| INGENIO (MODELS K172, K173, K174) AND ADVANTIO (MODELS K062, K063 AND K 064) PACEMAKERS (N970003/S140) | Boston Scientific Corp | 2013-03-12 |
| GYNECARE INTERCEED ABSORABLE ADHESION BARRIER (P880047/S020) | ETHICON, Inc. | 2013-03-12 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S039) | Edwards Lifesciences, LLC | 2013-03-12 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S041) | Edwards Lifesciences, LLC | 2013-03-12 |
| CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P) MODELS V172 AND V173 (P030005/S088) | Guidant Corp. | 2013-03-12 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINBE MITRAL BIOPROSTHESIS (P870077/S052) | Edwards Lifesciences, LLC | 2013-03-12 |
| CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESES (P860057/S105) | Edwards Lifesciences, LLC | 2013-03-12 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S022) | Edwards Lifesciences, LLC | 2013-03-12 |
| CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDSPERIMOUNT THEON PERCARDIAL AORTIC BIOPRO (P860057/S104) | Edwards Lifesciences, LLC | 2013-03-12 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S100) | Advanced Bionics | 2013-03-12 |
| PARADYM AND PARADYM RF CRT-D'S (P060027/S047) | MicroPort CRM USA, Inc. | 2013-03-12 |
| REPLY/ESPRIT PACEMAKERS (P950029/S073) | MicroPort CRM USA, Inc. | 2013-03-12 |
| PARADYM VR/DR AND PARADYM RF VR/DR ICD'S (P980049/S079) | MicroPort CRM USA, Inc. | 2013-03-12 |
| JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC (P050047/S030) | Allergan | 2013-03-11 |
| DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM (P050012/S050) | Dexcom, Inc. | 2013-03-11 |
| BELOTERO BALANCE (P090016/S004) | Merz North America, Inc. | 2013-03-08 |
| GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L (P080030/S004) | Glaukos Corporation | 2013-03-08 |
| ACUITY SPIRAL LEAD (P010012/S319) | Boston Scientific Corp | 2013-03-08 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S154) | Boston Scientific Corp | 2013-03-08 |
| VIDAS TOTAL PSA (P040008/S005) | bioMerieux, Inc. | 2013-03-08 |
| COAPTITE INJECTABLE IMPLANT (P040047/S025) | Merz North America, Inc. | 2013-03-08 |
| NAVISTAR®THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER (P040036/S030) | Biosense Webster, Inc. | 2013-03-07 |
| STOCKERT 70 RADIOFREQUENCY GENERATOR (P990071/S017) | Biosense Webster, Inc. | 2013-03-07 |