| PARADIGM REAL-TIME INSULIN PUMP & PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S098) | Medtronic Minimed | 2011-09-22 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S022) | Roche Molecular Systems, Inc. | 2011-09-22 |
| PREPSTAIN SYSTEM/PREPMATE (P970018/S024) | Bd Diagnostic Systems | 2011-09-21 |
| RX HERCULINK ELITE RENAL AND BILIARY STENT SYSTEM (P110001/S001) | Abbott Vascular | 2011-09-21 |
| ESTEEM (P090018/S012) | Envoy Medical Corporation | 2011-09-21 |
| PERIMOUNT BIOPROSTHESES (P860057/S079) | Edwards Lifesciences, LLC | 2011-09-21 |
| CAPSURE EPI EPICARDIAL PACING LEADS (P950024/S036) | Medtronic, Inc. | 2011-09-21 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S038) | Boston Scientific Corp | 2011-09-20 |
| CADENCE FAMILY OF ICDS (P910023/S265) | ABBOTT MEDICAL | 2011-09-20 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S088) | Boston Scientific Corp | 2011-09-20 |
| EON MINI NEUROSTIMULATION SYSTEM (P010032/S038) | ABBOTT MEDICAL | 2011-09-20 |
| EPIC HF FAMILY OF CRT-DS (P030054/S190) | ABBOTT MEDICAL | 2011-09-20 |
| TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE (P960007/S021) | Shire Regenerative Medicine | 2011-09-20 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S027) | Ortho-Clinical Diagnostics, Inc. | 2011-09-16 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S022) | Bard Peripheral Vascular, Inc. | 2011-09-16 |
| ETI-EBK PLUS KIT (P990043/S014) | DiaSorin, Inc. | 2011-09-16 |
| PRODISC - L TOTAL DISC REPLACEMENT (P050010/S011) | Centinel Spine, LLC | 2011-09-16 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S037) | W. L. Gore & Associates, Inc. | 2011-09-16 |
| ELECTROLESS NICKEL IMMERSION GOLD PROCESS (ENIG) PROCESS (P820003/S112) | Medtronic Cardiac Rhythm Disease Management | 2011-09-16 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S010) | Medtronic Vascular | 2011-09-16 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S019) | Medtimo, Inc. | 2011-09-16 |
| DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S003) | DePuy Orthopaedics, Inc. | 2011-09-16 |
| COGNIS CRT MODELS N118, N19 (P960040/S245) | Boston Scientific | 2011-09-15 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S020) | Ortho-Clinical Diagnostics, Inc. | 2011-09-15 |
| CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (P030002/S025) | Bausch & Lomb, Inc. | 2011-09-15 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S053) | Med-El Corp. | 2011-09-15 |
| TELIGEN ICD MODELS E102, E103, E110, E111 (P010012/S271) | Boston Scientific Corp | 2011-09-15 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S011) | Medtronic Cryocath, LP | 2011-09-15 |
| SURGICEL ABSORBABLE HEMOSTAT (N12159/S028) | ETHICON, Inc. | 2011-09-15 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S109) | Boston Scientific Corp | 2011-09-15 |
| FREEZOR/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE (P020045/S039) | Medtronic Cryocath, LP | 2011-09-15 |
| HANCOCK II PROCINE BIOPROSTHESIS (P980043/S033) | Medtronic, Inc. | 2011-09-14 |
| VISAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S060) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2011-09-14 |
| HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT (P790007/S031) | Medtronic Heart Valves | 2011-09-14 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S035) | Medtronic, Inc. | 2011-09-14 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S005) | Medtronic Vascular | 2011-09-14 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S040) | Medtronic, Inc. | 2011-09-14 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & 2000 HBSAG CONFIRMATORY (P010050/S014) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-13 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS (P010052/S010) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-13 |
| ANEURX STENT GRAFT SYSTEM (P990020/S034) | Medtronic Vascular | 2011-09-13 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC (P010053/S009) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-13 |
| AXSYM TOTAL PSA & ARCHITECT TOTAL PSA (P910007/S031) | Abbott Laboratories | 2011-09-13 |
| AXSYM FREE PSA & ARCHITECT FREE PSA (P980007/S022) | Abbott Laboratories | 2011-09-13 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC (P010051/S010) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-13 |
| IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP (P010007/S007) | Siemens Healthcare Diagnostics, Inc. | 2011-09-12 |
| AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S090) | Advanced Bionics | 2011-09-12 |
| IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 & 2000 THIRD GENERATION PSA (P930027/S013) | Siemens Healthcare Diagnostics, Inc. | 2011-09-12 |
| IMMULITE/IMMULITE 1000 FREE PSA AND IMMULITE 2000 FREE PSA (P060005/S006) | Siemens Medical Solutions Diagnostics Limited | 2011-09-12 |
| SOLESTA INJECTABLE GEL (P100014/S003) | Palette Life Sciences | 2011-09-09 |
| HERCEPTEST (P980018/S014) | Agilent Technologies Singapore (International) Pte , Ltd. | 2011-09-09 |
| VNS THERAPY SYSTEM (P970003/S134) | LivaNova USA, Inc. | 2011-09-09 |
| CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) SOFT CONTACT LENSES (P010019/S021) | Alcon Laboratories, Inc. | 2011-09-09 |
| DEFLUX INJECTABLE GEL (P000029/S070) | Palette Life Sciences | 2011-09-09 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S208) | ABBOTT MEDICAL | 2011-09-08 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S087) | ABBOTT MEDICAL | 2011-09-08 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S042) | ABBOTT MEDICAL | 2011-09-08 |
| EPIC HF / ATLAS + HF FAMILY OF CRT-DS (P030054/S197) | ABBOTT MEDICAL | 2011-09-08 |
| CADENCE/CURRENT FAMILY OF ICDS (P910023/S272) | ABBOTT MEDICAL | 2011-09-08 |
| EPIC HF/ATLAS+ HF/PROMOTE FAMILY OF CRT-DS (P030054/S198) | ABBOTT MEDICAL | 2011-09-08 |
| CRYSTLENS MODEL AT-45 ACCOMODATING INTROCULAR LENS (P030002/S024) | Bausch & Lomb, Inc. | 2011-09-08 |
| CADENCE FAMILY OF ICDS (P910023/S271) | ABBOTT MEDICAL | 2011-09-08 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF CRT-PS (P880006/S073) | St. Jude Medical, Inc. | 2011-09-08 |
| PSA IMMULITE ASSAY (P930027/S012) | Siemens Healthcare Diagnostics, Inc. | 2011-09-07 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S016) | Boston Scientific Corp | 2011-09-07 |
| TALENT ENDOLUMINALOCCLUDER SYSTEM (P070027/S031) | Medtronic Vascular | 2011-09-07 |
| AFP IMMULITE ASSAY (P010007/S006) | Siemens Healthcare Diagnostics, Inc. | 2011-09-07 |
| 5433 PATIENT CABLE PROXIMAL CONNECTOR AND MATERIAL (P820003/S111) | Medtronic Cardiac Rhythm Disease Management | 2011-09-07 |
| BIO OSTEOGEN SYSTEM (P790002/S027) | Ahp Eos Buyer, Inc. | 2011-09-07 |
| CAPSUREFIX MODELS 4076, 5076 (P930039/S062) | Medtronic, Inc. | 2011-09-07 |
| INTEGRITY CORONARY STENT SYSTEM (P030009/S058) | Medtronic, Ireland | 2011-09-07 |
| FPSA IMMULITE ASSAY (P060005/S005) | Siemens Medical Solutions Diagnostics Limited | 2011-09-07 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S007) | Medtronic Vascular | 2011-09-07 |
| CAPSUREFIX MODEL 5086MRI (P090013/S038) | Medtronic, Inc. | 2011-09-07 |
| TRIFECTA VALVE (P100029/S007) | ABBOTT MEDICAL | 2011-09-07 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S014) | Hologic, Inc. | 2011-09-06 |
| PATHWAY ANTI-HER-2/NEU (4B5) RABBITT MONOCLONAL PRIMARY ANTIBODY (P990081/S010) | Ventana Medical Systems, Inc. | 2011-09-06 |
| MEDTRONIC INTERSTIM SACRAL NERVE THERAPY SYSTEM (P080025/S020) | Medtronic Neuromodulation | 2011-09-06 |
| DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM (P050012/S035) | Dexcom, Inc. | 2011-09-02 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S046) | Corcym S.r.l. | 2011-09-02 |
| ANTI-HBS IMMULITE ASSAY (P010052/S009) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-02 |
| ANTI-HBC IMMULITE ASSAY (P010051/S009) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-02 |
| BARD E-LUMINEXX VASCULAR STENT (P080007/S005) | Bard Peripheral Vascular, Inc. | 2011-09-02 |
| HYDRELLE (P050033/S012) | Anika Therapeutics, Inc. | 2011-09-02 |
| ANTI-HBCM IMMULITE ASSAY (P010053/S008) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-02 |
| HBSAG IMMULITE ASSAY (P010050/S013) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-09-02 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S055) | Med-El Corp. | 2011-09-02 |
| XACT CARTOID STENT SYSTEM (P040038/S023) | Abbott Vascular, Inc. | 2011-09-02 |
| RELIANCE 4-SITE LEADS (P910073/S094) | Boston Scientific | 2011-09-01 |
| RX ACCULINK SELF-EXPANDING STENT SYSTEM (P040012/S041) | Abbott Vascular | 2011-09-01 |
| ALTERNATE LASER SOURCE (P950029/S062) | MicroPort CRM USA, Inc. | 2011-09-01 |
| PACKAGED DIODES (P090013/S037) | Medtronic, Inc. | 2011-09-01 |
| VARIOUS FAMILIES OF PULSE GENERATORS AND ACCESSORIES (P830060/S067) | Boston Scientific | 2011-09-01 |
| VENTAK PRX AND VENTAK MINI AUTOMATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ACID) SYSTEMS (P910077/S117) | Boston Scientific | 2011-09-01 |
| MULTI-LINK FAMILY OF CORONARY STENT SYSTEM (P020047/S038) | Abbott Vascular | 2011-09-01 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S079) | Abbott Vascular, Inc. | 2011-09-01 |
| MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS (P970020/S067) | Abbott Vascular, Inc. | 2011-09-01 |
| XACT CARTOID STENT SYSTEM (P040038/S022) | Abbott Vascular, Inc. | 2011-09-01 |
| VNS THERAPY SYSTEM (P970003/S133) | LivaNova USA, Inc. | 2011-08-31 |
| HOME ACCESS HEPATITIS C CHECK TEST SYSTEM (P980046/S008) | Pwn Health Chicago, LLC | 2011-08-31 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S040) | Johnson & Johnson Surgical Vision, Inc. | 2011-08-31 |