| REVO MRI (P090013/S056) | Medtronic, Inc. | 2012-04-02 |
| HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S094) | Advanced Bionics | 2012-04-02 |
| TRANSVENE LEADS (P920015/S089) | Medtronic, Inc. | 2012-04-02 |
| ACTIVITRAX (P890003/S248) | Medtronic, Inc. | 2012-04-02 |
| INSYNC MODEL 8040 PULSE GENERATOR (P010015/S158) | Medtronic, Inc. | 2012-04-02 |
| KAPPA 400 (P980035/S263) | Medtronic, Inc. | 2012-04-02 |
| VITATRON (P990001/S102) | Medtronic, Inc. | 2012-04-02 |
| VITATRON (P990001/S103) | Medtronic, Inc. | 2012-04-02 |
| INSYNC MODEL 8040 PULSE GENERATOR (P010015/S156) | Medtronic, Inc. | 2012-04-02 |
| GEM DR (P980016/S342) | Medtronic Cardiac Rhythm Disease Management | 2012-04-02 |
| REVO MRI (P090013/S057) | Medtronic, Inc. | 2012-04-02 |
| GEM DR (P980016/S344) | Medtronic Cardiac Rhythm Disease Management | 2012-04-02 |
| EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S014) | Ferring Pharmaceuticals, Inc. | 2012-03-30 |
| EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER (P040036/S029) | Biosense Webster, Inc. | 2012-03-30 |
| EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER & THERMOCOOL SF NAV CATHETER (P030031/S040) | Biosense Webster, Inc. | 2012-03-30 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S049) | Boston Scientific Corp | 2012-03-30 |
| EZ STEER NAV ELECTROPHYSIOLOGY CATHETER (P990025/S030) | Biosense Webster, Inc. | 2012-03-30 |
| PERFLUORON (P950018/S015) | Alcon Laboratories | 2012-03-30 |
| INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S253) | Boston Scientific | 2012-03-30 |
| INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S283) | Boston Scientific Corp | 2012-03-30 |
| NAVISTAR DS ELECTROPHYSIOLOGY CATHETER (P010068/S026) | Biosense Webster, Inc. | 2012-03-30 |
| LCS TOTAL KNEE SYSTEM (P830055/S126) | Depuy, Inc. | 2012-03-30 |
| BVI 1% OVD (!% SODIUM HYALURONATE VICSCOELASTIC SURGICAL AID FLUID (P960011/S021) | Altacor , Ltd. | 2012-03-30 |
| PARADIGM REAL-TIME INSULIN PUMP (P980022/S108) | Medtronic Minimed | 2012-03-30 |
| CARDIO MESSENGER II & CARDIO MESSENGER II-S FAMILIES (P950037/S102) | Biotronik, Inc. | 2012-03-29 |
| CARDIO MESSENGER & CARDIO MESSENGER II-S FAMILIES (P050023/S049) | Biotronik, Inc. | 2012-03-29 |
| HEARTMATE II LVAS (P060040/S016) | ABBOTT MEDICAL | 2012-03-29 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S016) | Allergan | 2012-03-29 |
| LUMAX ICDS AND CRT-DS (P050023/S050) | Biotronik, Inc. | 2012-03-29 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S042) | Abbott Vascular | 2012-03-29 |
| TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S254) | Boston Scientific | 2012-03-28 |
| COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S284) | Boston Scientific Corp | 2012-03-28 |
| ELECSYS HBSAG (P990012/S014) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170 (P100031/S006) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS ANTI-HBS (P010054/S019) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS ANTI-HCV ON COBAS E 601 (P090008/S009) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170 (P110025/S006) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS ANTI-HBC IGM ON COBAS E 601 (P110022/S006) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170 (P090009/S008) | Roche Diagnostics Corp. | 2012-03-28 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S028) | Hologic, Inc. | 2012-03-28 |
| ELECSYS ANTI-HBC ON ELECSYS 2010 (P100032/S006) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS TOTAL PSA (P990056/S017) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS ANTI-HCV ON COBAS E 411 (P090007/S008) | Roche Diagnostics Corp. | 2012-03-28 |
| ELECSYS FREE PSA (P000027/S015) | Roche Diagnostics Corp. | 2012-03-28 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S061) | Med-El Corp. | 2012-03-28 |
| ELECSYS ANTI-HBC IGM ON COBAS E 411 (P110031/S006) | Roche Diagnostics Corp. | 2012-03-28 |
| MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL PUMP, PARADIGM REAL-TIME PUMP, AND GUARDIAN REAL-TIME MONITOR (P980022/S104) | Medtronic Minimed | 2012-03-28 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S012) | Natus Medical Incorporated | 2012-03-27 |
| HBSAG IMMULITE SUBSTRATE REAGENT (P010050/S015) | Siemens Healthcare Diagnostics Products, Ltd. | 2012-03-27 |
| ANTI-HBS IMMULITE SUBSTRATE REAGENT (P010052/S011) | Siemens Healthcare Diagnostics Products, Ltd. | 2012-03-27 |
| ANTI-HBCM IMMULITE SUBSTRATE REAGENT (P010053/S010) | Siemens Healthcare Diagnostics Products, Ltd. | 2012-03-27 |
| ANTI-HBC IMMULITE SUBSTRATE REAGENT (P010051/S011) | Siemens Healthcare Diagnostics Products, Ltd. | 2012-03-27 |
| STAARVISC II & SHELLGEL SODIUM HYAURONATE (P000046/S015) | Anika Therapeutics, Inc. | 2012-03-27 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S064) | Cochlear Americas | 2012-03-26 |
| SPRINT QUATTRO SECURE LEAD (DF4) (P920015/S087) | Medtronic, Inc. | 2012-03-26 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S064) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2012-03-26 |
| EVIA / ENTOVIS FAMILY PULSE GENERATORS (P950037/S101) | Biotronik, Inc. | 2012-03-23 |
| TAXUS LIBERTE MR CORONARY STENT SYSTEM & TAXUS LIBERTE OTW CORONARY STENT SYSTEM (P060008/S072) | Boston Scientific Corp | 2012-03-23 |
| JEWEL AF MODEL 7250 (P980050/S071) | Medtronic, Inc. | 2012-03-23 |
| INSYNC MODEL 8040 PULSE GENERATOR (P010015/S155) | Medtronic, Inc. | 2012-03-23 |
| 7261A PCD (P900061/S112) | Medtronic Cardiac Rhythm Disease Management | 2012-03-23 |
| MECHANICAL HEART VALVE (P810002/S081) | ABBOTT MEDICAL | 2012-03-23 |
| 4965 EPICARDIAL LEAD (P950024/S041) | Medtronic, Inc. | 2012-03-23 |
| BLAZER II, BLAZER II HTD CARDIAC ABLATION CATHETERS & BLAZER PRIME HTD CARDIAC ABLATION CATHETER & STERILE CABLES (P920047/S048) | Boston Scientific Corp | 2012-03-23 |
| SELECTSECURE (P030036/S041) | Medtronic Cardiac Rhythm Disease Management | 2012-03-23 |
| 4003/4503 CAPSURE (P830061/S075) | Medtronic Cardiac Rhythm Disease Management | 2012-03-23 |
| 4068 CAPSUREFIX (P930039/S066) | Medtronic, Inc. | 2012-03-23 |
| 4195 ATTAIN STARFIX (P060039/S034) | Medtronic, Inc. | 2012-03-23 |
| VERIFLEX MR CORONARY STENT SYSTEM & VERIFLEX OTW CORONARY STENT SYSTEM (P040016/S073) | Boston Scientific Scimed, Inc. | 2012-03-23 |
| INSYNC ICD MODEL 7272 (P850089/S087) | Medtronic Cardiac Rhythm Disease Management | 2012-03-23 |
| ACTIVITRAX (P890003/S246) | Medtronic, Inc. | 2012-03-23 |
| ATAKR RFCA SYSTEM (P930029/S036) | Medtronic, Inc. | 2012-03-23 |
| 4196 ATTAIN ABILITY LEAD (P080006/S040) | Medtronic, Inc. | 2012-03-23 |
| BLAZER II XP, BLAZER PRIME XP & BLAZER XP RPM CARDIAC ABLATION CATHETERS & STERILE CABLES (P020025/S029) | Boston Scientific | 2012-03-23 |
| ION PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S005) | Boston Scientific Corp | 2012-03-23 |
| MULTI-LINK OTW ULTRA & MULTI-LINK RX ULTRA CORONARY STENT SYSTEM (P970020/S073) | Abbott Vascular, Inc. | 2012-03-23 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S107) | Boston Scientific Corp | 2012-03-23 |
| INSYNC ICD MODEL 7272 (P010031/S294) | Medtronic Cardiac Rhythm Disease Management | 2012-03-23 |
| TRANSVENE LEADS (P920015/S088) | Medtronic, Inc. | 2012-03-23 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S047) | Abbott Vascular | 2012-03-23 |
| EXPRESS SD RENAL MR PREMOUNTED STENT SYSTEM (P060006/S021) | Boston Scientific Corp | 2012-03-23 |
| KAPPA 700 (P820003/S115) | Medtronic Cardiac Rhythm Disease Management | 2012-03-23 |
| ARISTA AH ABSORBABLE HEMOSTAT (P050038/S011) | Davol, Inc. | 2012-03-23 |
| VITATRON (P990001/S101) | Medtronic, Inc. | 2012-03-23 |
| KAPPA 400 (P980035/S262) | Medtronic, Inc. | 2012-03-23 |
| CHILLI II COOLED ABLATION SYSTEM & STERILE CABLES (P980003/S030) | Boston Scientific Corp | 2012-03-23 |
| THERMACOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL CATHETERS (P030031/S038) | Biosense Webster, Inc. | 2012-03-23 |
| REVO MRI (P090013/S055) | Medtronic, Inc. | 2012-03-23 |
| 4195 ATTAIN STARFIX (P980016/S341) | Medtronic Cardiac Rhythm Disease Management | 2012-03-23 |
| EXPRESS 2 MR CORONARY STENT SYSTEM & EXPRESS 2 OTW CORONARY STENT SYSTEM (P020009/S075) | Boston Scientific Scimed, Inc. | 2012-03-23 |
| PROGEL PLEURAL LEAK SEALANT (P010047/S016) | Neomend, Inc. | 2012-03-23 |
| PRECISE, PRECISE RX, AND PRECISE PRO RXNITINOL STENT SYSTEMS (P030047/S024) | Cordis US Corporation | 2012-03-22 |
| NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM (P020036/S023) | Cordis US Corporation | 2012-03-22 |
| CONCERTO / PROTECTA (P010031/S293) | Medtronic Cardiac Rhythm Disease Management | 2012-03-22 |
| CARPENTIER-EDWARDS BIOPROSTHESIS MODEL 2625 AND 6625 (P870056/S046) | Edwards Lifesciences, LLC | 2012-03-22 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S008) | Boston Scientific Corp | 2012-03-22 |
| XIENCE V, XIENCE NANO, PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S091) | Abbott Vascular, Inc. | 2012-03-22 |
| ARCHITECT FREE PSA (P980007/S025) | Abbott Laboratories | 2012-03-22 |
| CARELINK HOME MONITOR MODEL 2491 (P890003/S245) | Medtronic, Inc. | 2012-03-22 |
| XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S015) | Abbott Vascular | 2012-03-22 |