| ESTEEM (P090018/S003) | Envoy Medical Corporation | 2010-08-16 |
| MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S008) | Mentor Corp. | 2010-08-16 |
| ENPULSE/KAPPA 700/800/900/ADAPTA/SIGMA/RELIA/SENSIA/VERSA (P980035/S179) | Medtronic, Inc. | 2010-08-13 |
| CONTAK CD/EASYTRAK/LIVIAN/COGNIS/ACUITY SPIRAL (P010012/S246) | Boston Scientific Corp | 2010-08-13 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S004) | Boston Scientific Corp | 2010-08-13 |
| SOFTEC HD POSTERIOR CHAMBER INTROCULAR LENS (P090022/S002) | Lenstec, Inc. | 2010-08-13 |
| ECG CABLE/CAPSURE VDD LEADS/VITATRON BRILLANT S+ VDD LEADS/VITATRON LEGACY/LEGACY II/VISA (P890003/S196) | Medtronic, Inc. | 2010-08-13 |
| ACCESSORY (UPSIZING SLEEVE)/ LEAD END PIN CAP (P900061/S093) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S014) | Bard Peripheral Vascular | 2010-08-13 |
| CS-SVC TRANSVENE LEAD (P980050/S052) | Medtronic, Inc. | 2010-08-13 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S061) | Boston Scientific Scimed, Inc. | 2010-08-13 |
| DA+ C-SERIES & DA+ T-SERIES (P990001/S073) | Medtronic, Inc. | 2010-08-13 |
| DISPOSABLE COVER (P820003/S096) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| CAPSUREFIX/CAPSUREFIX NOVUS/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S (P930039/S042) | Medtronic, Inc. | 2010-08-13 |
| CAPSURE VDD LEADS/WRENCH KIT/VITATRON BRILLANT S+ VDD LEADS (P890003/S197) | Medtronic, Inc. | 2010-08-13 |
| CADENCE/CURRENT FAMILY OF ICDS (P910023/S245) | ABBOTT MEDICAL | 2010-08-13 |
| ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN CAP (P900061/S094) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S030) | St Jude Medical | 2010-08-13 |
| ATTAIN/INSYNC/INSYNC III (P010015/S096) | Medtronic, Inc. | 2010-08-13 |
| CAPSURE FIX LEAD/MAXIMO/MARQUIS/INTRINSIC/ENTRUST/VIRTUOSO (P980016/S253) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS (P030054/S163) | ABBOTT MEDICAL | 2010-08-13 |
| RF MARINR/RF MARINR NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II/ RF CONTACTR (P930029/S025) | Medtronic, Inc. | 2010-08-13 |
| CAPSURE EPI UNIPOLAR/BIPOLAR LEADS (P950024/S023) | Medtronic, Inc. | 2010-08-13 |
| EXPRESS2 CORONARY STENT SYSTEMS (MONORAIL & OVER-THE-WIRE) (P020009/S056) | Boston Scientific Scimed, Inc. | 2010-08-13 |
| IMPLANTABLE PULSE GENERATOR PACEMAKER (P940031/S068) | Boston Scientific | 2010-08-13 |
| ATS OPEN PIVOT HEART VALVE & ATS OPEN PIVOT AORTIC VALVED GRAFT (P990046/S022) | Medtronic Ats Medical, Inc. | 2010-08-13 |
| CS-SVC TRANSVENE LEAD (P980050/S051) | Medtronic, Inc. | 2010-08-13 |
| TRANSVENE SVC LEAD/SUBCUTANEOUS DEFIBRILLATION LEAD/IS-1 CONNECTOR PORT PIN PLUG KIT (P920015/S064) | Medtronic, Inc. | 2010-08-13 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (MONORAIL & OVER-THE-WIRE) (P030025/S078) | Boston Scientific Corp | 2010-08-13 |
| ATTAIN STARFIX (P060039/S015) | Medtronic, Inc. | 2010-08-13 |
| ROTABLATOR SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER (P900056/S099) | Boston Scientific Corp | 2010-08-13 |
| INSYNC SENTRY & INSYNC MAXIMO (P010031/S209) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| VENTAK AV/VENTAK PRIZM DR/VR/VITALITY/CONFIENT/TELIGEN (P960040/S226) | Boston Scientific | 2010-08-13 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S031) | St Jude Medical | 2010-08-13 |
| ABBOTT REALTIME HBV ASSAY (P080026) | Abbott Molecular, Inc. | 2010-08-13 |
| CAPSURE SENSE/SP NOVUS LEADS/VITATRON CRYSTALLINE/EXCELLENCE+/PS+ (P830061/S054) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| PTCA CATHETERS (P860019/S259) | Scimed Life Systems, Inc. | 2010-08-13 |
| 350 SERIES/ADAPTOR/AT500/ENPULSE/ENRHYTHM/KAPPA 600/650/700/800/900/RELIA/SENSIA/VERSA/SIGMA/PATIENT ACTIVATOR (P980035/S180) | Medtronic, Inc. | 2010-08-13 |
| LEAD & Y ADAPTOR/TUNNELING TOOL/TRANSVENE SVC LEAD/SUBCUTANEOUS DEFIBRILLATION LEAD/IS-1 CONNECTOR PORT PIN PLUG KIT (P920015/S063) | Medtronic, Inc. | 2010-08-13 |
| BSC CRV ENDOTAK LEADS (P910073/S085) | Boston Scientific | 2010-08-13 |
| KAPPA 400 (P970012/S072) | Medtronic, Inc. | 2010-08-13 |
| CAPSURE SP/SP NOVUS LEADS/CAPSURE SENSE/VITATRON CRYSTALLINE/VITATRON EXCELLENCE PS +/+ (P830061/S053) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| SELECTSECURE & ANCHORING SLEEVE KIT (P030036/S021) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| CAPSURE SENSE/SP NOVUS/VITATRON CRYSTALINE/EXCELLENCE PS+ (P830061/S055) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| ANCHORING SLEEVE KIT (P030036/S020) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD/INCHECK PATIENT ASSISTANT (P980050/S053) | Medtronic, Inc. | 2010-08-13 |
| VENTAK PRX & VENTAK MINI I-IV (P910077/S106) | Boston Scientific | 2010-08-13 |
| ADAPTA/VERSA/SENSIA/RELIA (P980035/S181) | Medtronic, Inc. | 2010-08-13 |
| CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II (P980016/S254) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| CAPSURE SPZ/Z NOVUS/SP NOVUS LEADS/VITATRON EXCELLENCE S+/SS+/VITATRON IMPULSE/IMPULSE II (P850089/S067) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| ATTAIN LV/CS LEADS (P010015/S095) | Medtronic, Inc. | 2010-08-13 |
| CAPSURE FIX NOVUS/SUREFIX LEADS/CAPSURE FIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET+/VITATRON PIROUET S+ (P930039/S040) | Medtronic, Inc. | 2010-08-13 |
| CONCERTO/II/CONSULTA/INSYNC ICD/MARQUIS/MAXIMO/II MARQUIS/MAXIMO II/II PROTECT/III MARQUIS/SENTRY/CONEXUS ACTIVATOR (P010031/S210) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| ATTAIN (P080006/S013) | Medtronic, Inc. | 2010-08-13 |
| EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS (P030054/S164) | ABBOTT MEDICAL | 2010-08-13 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S024) | Medtronic, Inc. | 2010-08-13 |
| ATTAIN ABILITY (P080006/S012) | Medtronic, Inc. | 2010-08-13 |
| CAPSURE SP Z/Z NOVUS/SP NOVUS LEADS/VITATRON EXCELLENCE SS+/IMPULSE II (P850089/S069) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| DISPOSABLE COVER/EXTERNAL PULSE GENERATORS/CABLES/ADAPTOR/SURGICAL CABLE/PATIENT SAFETY CABLES/DISPOSABLE POUCH/SEM (P820003/S097) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| CAPSURE FIX NOVUS LEADS/SUREFIX LEAD/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+ (P930039/S041) | Medtronic, Inc. | 2010-08-13 |
| ACE HEADER/TRANSVENE DEFIBRILLATION LEAD/LEAD END PIN CAP/UPSIZING SLEEVE (P900061/S092) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| ATTAIN LV/CS/OTW LEADS (P010015/S094) | Medtronic, Inc. | 2010-08-13 |
| CONTAK RENEWAL TR (P030005/S065) | Guidant Corp. | 2010-08-13 |
| RF MARINR/NTC/5RF MARINR/RF CONDUCTR/RF ENHANCR II/RF CONTACTR (P930029/S024) | Medtronic, Inc. | 2010-08-13 |
| CAPSURE EPI UNIPOLAR/BIPOLAR LEADS (P950024/S022) | Medtronic, Inc. | 2010-08-13 |
| CAPSURE Z/SP NOVUS LEADS/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II (P850089/S068) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S013) | Bard Peripheral Vascular | 2010-08-13 |
| ATTAIN STARFIX (P060039/S014) | Medtronic, Inc. | 2010-08-13 |
| KAPPA 400 DR/SR/ REMOTE ASSISTANT (P970012/S073) | Medtronic, Inc. | 2010-08-13 |
| CADENCE/CURRENT FAMILY OF ICDS (P910023/S244) | ABBOTT MEDICAL | 2010-08-13 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S041) | Abbott Vascular, Inc. | 2010-08-13 |
| CAPSURE/BRILLIANT S+ VDD LEADS/PRODIGY SR/WRENCH KIT/THERA-I/VITATRON LEGACY/LEGACY II/VISA/PACING SYSTEM ANALYZER (P890003/S198) | Medtronic, Inc. | 2010-08-13 |
| IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT QUATTRO/QUATTRO SECURE/SUBCUTANEOUS LEAD/SUB-Q TUNNELING TOOL/TRANSVENE SVC LEAD (P920015/S065) | Medtronic, Inc. | 2010-08-13 |
| ANCHORING SLEEVE KIT & SELECTSECURE (P030036/S019) | Medtronic Cardiac Rhythm Disease Management | 2010-08-13 |
| RESTYLANE INJECTABLE GEL (P040024/S049) | Q-Med AB | 2010-08-12 |
| KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM (P050027/S001) | KARL STORZ Endoscopy-America, Inc. | 2010-08-10 |
| REALIZE ADJUSTABLE GASTRIC BAND-C AND INJECTION PORT (P070009/S007) | Obtech Medical GmbH | 2010-08-10 |
| VISTAKON (ETAFILCON A) CONTACT LENS (N18033/S044) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2010-08-09 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S035) | W. L. Gore & Associates, Inc. | 2010-08-06 |
| EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS (P030054/S160) | ABBOTT MEDICAL | 2010-08-06 |
| FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CCT.2 CRYOCONSOLE (P020045/S028) | Medtronic Cryocath, LP | 2010-08-06 |
| PLASMAFLO OP-05W(A) (P820033/S006) | Asahi Kasei Medical Co., Ltd. | 2010-08-06 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S017) | W. L. Gore & Associates, Inc. | 2010-08-06 |
| COGNIS PULSE GENERATORS (P010012/S245) | Boston Scientific Corp | 2010-08-06 |
| CADENCE/CURRENT FAMILY OF ICDS (P910023/S241) | ABBOTT MEDICAL | 2010-08-06 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S027) | W. L. Gore & Associates, Inc. | 2010-08-06 |
| EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS (P030054/S161) | ABBOTT MEDICAL | 2010-08-06 |
| CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S080) | Cordis Corp. | 2010-08-06 |
| TELIGEN PULSE GENERATORS (P960040/S225) | Boston Scientific | 2010-08-06 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S054) | W. L. Gore & Associates, Inc. | 2010-08-06 |
| CADENCE/CURRENT FAMILY OF ICDS (P910023/S242) | ABBOTT MEDICAL | 2010-08-06 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S020) | W. L. Gore & Associates, Inc. | 2010-08-06 |
| ATTAIN ABILITY LEAD (P080006/S011) | Medtronic, Inc. | 2010-08-05 |
| NEOMEND PROGEL PLEURAL AIR LEAK SEALANT (P010047/S004) | Neomend, Inc. | 2010-08-05 |
| QUICKFLEX OF LEFT HEART LEADS (P030054/S158) | ABBOTT MEDICAL | 2010-08-05 |
| SPRINT QUATTRO (P920015/S062) | Medtronic, Inc. | 2010-08-05 |
| SYNCHROMED II INFUSION PUMP (P860004/S133) | Medtronic, Inc. | 2010-08-04 |
| LUMAX FAMILY OF ICDS AND CRT-DS (P050023/S034) | Biotronik, Inc. | 2010-08-04 |
| ADAPTA/RELIA/SENSIA/VERSA (P980035/S162) | Medtronic, Inc. | 2010-08-04 |
| VNS THERAPY SYSTEM (P970003/S111) | LivaNova USA, Inc. | 2010-08-04 |