| BTE FIREFLY (ADULT) (P940022/S024) | Advanced Bionics Corp. | 2002-09-23 |
| DIAGNOSTIC DUETT SEALING DEVICE, MODEL 2200; DIAGNOSTIC DUETT PRO SEALING DEVICE, MODEL 2210; AND D-STAT FLOWABLE HEMOS0 (P990037/S011) | Vascular Solutions, Inc. | 2002-09-23 |
| DEFLUX INJECTABLE GEL (P000029/S001) | Palette Life Sciences | 2002-09-23 |
| B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM (P940016/S009) | B. Braun Avitum AG | 2002-09-20 |
| GALILEO (TM) III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S004) | Guidant Corp. | 2002-09-19 |
| GENESIS NEUROSTIMULATION (IPG) SYSTEM (P010032/S003) | ABBOTT MEDICAL | 2002-09-18 |
| STORMER ZIPPER MX BALLOON DILATATION CATHETER (P790017/S077) | Medtronic, Ireland | 2002-09-18 |
| DRILAC CUBES AND GRANULES (P800012/S009) | Osmed, Inc. | 2002-09-17 |
| QUICKSEAL ARTERIAL CLOSURE SYSTEM WITH Q-FOAM (P010049/S001) | Sub-Q, Inc. | 2002-09-16 |
| S7 WITH DISCRETE TECHNOLOGY OVER-THE -WIRE CORONARY STENT SYSTEM/S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY (P970035/S036) | Medtronic, Ireland | 2002-09-13 |
| IMAGECHECKER M1000 SYSTEM (P970058/S014) | Hologic, Inc. | 2002-09-13 |
| MULTI LINK RX ZETA CORONARY STENT SYSTEM/ MULTI LINK OTW ZETA CORONARY STENT SYSTEM (P970020/S042) | Abbott Vascular, Inc. | 2002-09-13 |
| FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM (P000035/S002) | Nexus CMF, LLC | 2002-09-12 |
| ABBOTT AXSYM AFP (P820060/S015) | Abbott Laboratories | 2002-09-12 |
| FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM (P000023/S001) | Nexus CMF, LLC | 2002-09-12 |
| FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM (P000035/S001) | Nexus CMF, LLC | 2002-09-12 |
| FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM (P000023/S002) | Nexus CMF, LLC | 2002-09-12 |
| EXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMS (P020009) | Boston Scientific Scimed, Inc. | 2002-09-11 |
| BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S004) | Medtimo, Inc. | 2002-09-10 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S035) | Boston Scientific Corp | 2002-09-10 |
| NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S007) | Biosense Webster, Inc. | 2002-09-10 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S002) | Siemens Healthcare Diagnostics | 2002-09-10 |
| AIA-PACK PA (P910065/S003) | Tosoh Bioscience, Inc. | 2002-09-09 |
| CLARION CII BIONIC EAR, HIFOCUS ELECTRODE WITHOUT POSITIONER (MODEL AB-5100H-11A) & HIRES SOFTWARE (MODEL CI-6055) (P940022/S023) | Advanced Bionics Corp. | 2002-09-09 |
| CLARION CII BIONIC EAR SYSTEM (P960058/S023) | Advanced Bionics | 2002-09-09 |
| TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD SYSTEM (P000009/S004) | Biotronik, Inc. | 2002-09-09 |
| ABBOTT IMX AFP ASSAY (P820060/S014) | Abbott Laboratories | 2002-09-05 |
| ABBOTT HAVAB/HAVAB EIA/IMX HAVAB (P780012/S012) | Abbott Laboratories | 2002-09-05 |
| HAVAB-M (R) EIA (P790019/S012) | Abbott Laboratories | 2002-09-05 |
| CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S008) | Medtronic Minimed | 2002-09-05 |
| IMX HAVAB-M (P790019/S015) | Abbott Laboratories | 2002-09-05 |
| ABBOTT HAVAB-M 7180/ HAVAB-M EIA 9843/IMX HAVAB-M 2263 (P790019/S014) | Abbott Laboratories | 2002-09-05 |
| HAVAB (R) EIA (P780012/S010) | Abbott Laboratories | 2002-09-05 |
| IMX HAVAB (P780012/S013) | Abbott Laboratories | 2002-09-05 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064/S017) | Bunnell, Inc. | 2002-09-05 |
| ABBOTT ANTI-DELTA (EIA) ASSAY (P850062/S003) | Abbott Laboratories | 2002-09-05 |
| TDX/TDXFLX CYCLOSPORINE/METABOLITES WHOLE BLOOD (P890025/S013) | Abbott Laboratories | 2002-09-05 |
| ABBOTT HAVAB-M/HAVAB-M EIA/IMX HAVAB-M (P790019/S013) | Abbott Laboratories | 2002-09-05 |
| IMX TACROLIMUS II (P970007/S003) | Abbott Laboratories | 2002-09-05 |
| ABBOTT HAVAB/HAVAB EIA/IMX HAVAB (P780012/S011) | Abbott Laboratories | 2002-09-05 |
| IMX TACROLIMUS II (P970007/S004) | Abbott Laboratories | 2002-09-05 |
| IMX AND AXSYM PSA (P910007/S008) | Abbott Laboratories | 2002-09-05 |
| TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD (P890025/S014) | Abbott Laboratories | 2002-09-05 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S004) | Med-El Corp. | 2002-09-04 |
| UROLOGIX TARGIS SYSTEM (P970008/S018) | Urologix, LLC | 2002-09-04 |
| PHEMFILCON A (P830037/S046) | Alcon Laboratories, Inc. | 2002-09-04 |
| IMMUNO 1 COMPLEXED PSA ASSAY (P990055/S005) | Siemens Healthcare Diagnostics | 2002-09-04 |
| SOUNDTEC DIRECT IPCA SYSTEM (P010023/S001) | Ototronix, LLC | 2002-09-04 |
| HYDROVIEW IOL BLANK MATERIAL (P990014/S002) | Bausch & Lomb, Inc. | 2002-09-04 |
| SALINE-FILLED BREAST IMPLANTS (P990074/S011) | Allergan | 2002-09-04 |
| SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS. (P990075/S009) | Mentor Worldwide, LLC | 2002-09-03 |
| STAARVISC II SODIUM HYALURONATE AND SHELLGEL SODIUM HYALURONATE (P000046/S002) | Anika Therapeutics, Inc. | 2002-08-30 |
| ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U) (P980023/S010) | Biotronik, Inc. | 2002-08-30 |
| GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF2000N (P830063/S002) | Vantive US Healthcare, LLC | 2002-08-28 |
| BIOENTERICS LAP-BAND (P000008/S001) | Medtimo, Inc. | 2002-08-26 |
| GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S008) | Animas Corp. | 2002-08-26 |
| GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S014) | Animas Corp. | 2002-08-23 |
| SALINE-FILLED BREAST IMPLANTS (P990074/S013) | Allergan | 2002-08-23 |
| BX VELOCITY STENT W/HEPACOAT ON RAPTOR/ON SONIC OTW/ON RAPTORRAIL STENT DELIVERY SYSTEM (P900043/S041) | Cordis Corp. | 2002-08-22 |
| GALILEO/INTRAVASCULAR RADIOTHERPY SYSTEM (P000052/S005) | Guidant Corp. | 2002-08-22 |
| TMX-2000 BPH THERMOTHERAPY SYSTEM (P000043/S004) | Boston Scientific Corp | 2002-08-22 |
| BX VELOCITY WITH HEPACOAT ON RAPTOR STENT SYSTEM (P900043/S037) | Cordis Corp. | 2002-08-22 |
| BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE DELIVERY SYSTEM, BX VELOCITY STENT ON RAPTORRAIL TX DELIVERY SYSTEM (P900043/S036) | Cordis Corp. | 2002-08-22 |
| THE PERCLOSE A-T (AUTO TIE) SMC DEVICE (P960043/S041) | Abbott Vascular, Inc. | 2002-08-21 |
| MEDSTONE STS LITHOTRIPTER (P970042/S002) | Medstone Intl., Inc. | 2002-08-20 |
| STINGER, STINGER M, STINGER S AND STINGER SM ABLATION CATHETERS WITH 8F/5MM DISTAL ELECTRODE (P000020/S007) | Boston Scientific Corp | 2002-08-19 |
| AFFINITY ANTERIOR CERVICAL CAGE SYSTEM (P000028/S001) | Medtronic Sofamor Danek USA, Inc. | 2002-08-13 |
| MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE (P880086/S089) | ABBOTT MEDICAL | 2002-08-13 |
| EBI BONE HEALING SYSTEM - MODEL 2001 (P790002/S022) | Ahp Eos Buyer, Inc. | 2002-08-13 |
| VASOSEAL ELITE VHD/ES DEVICE (P920004/S018) | St. Jude Medical, Inc. | 2002-08-13 |
| MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE (P830045/S082) | St. Jude Medical, Inc. | 2002-08-13 |
| MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE (P910023/S062) | ABBOTT MEDICAL | 2002-08-13 |
| LT-CAGE TAPERED FUSION DEVICE (P970015/S020) | Sofamor Danek | 2002-08-12 |
| APLIGRAF (P950032/S033) | Organogenesis, Inc. | 2002-08-12 |
| GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S008) | Guidant Corp. | 2002-08-09 |
| MCGHAN SALINE-FILLED BREAST IMPLANT (P990074/S012) | Allergan | 2002-08-08 |
| VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM (P930016/S015) | Amo Manufacturing USA, LLC | 2002-08-07 |
| WAVSTAT OPTICAL BIOPSY SYSTEM (P990050/S005) | Spectra Science | 2002-08-06 |
| ACS MULTI-LINK RX/OTW DUET CORONARY STENT SYSTEMS (P970020/S040) | Abbott Vascular, Inc. | 2002-08-06 |
| GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S010) | Guidant Corp. | 2002-08-02 |
| GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S006) | Guidant Corp. | 2002-08-02 |
| HEPACOAT ON BX SONIC BALLOON-EXPANDABLE STENT OTW DELIVERY SYSTEM (P900043/S035) | Cordis Corp. | 2002-08-02 |
| BX SONIC BALLOON EXPANDABLE STENT OTW DELIVERY SYSTEM (P900043/S038) | Cordis Corp. | 2002-08-02 |
| UROLOGIX TARGIS SYSTEM (P970008/S022) | Urologix, LLC | 2002-08-01 |
| BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S002) | Medtimo, Inc. | 2002-08-01 |
| UROLOGIX TARGIS SYSTEM (P970008/S019) | Urologix, LLC | 2002-08-01 |
| SCIMED RADIUS STENT AND DELIVERY SYSTEM (P970061/S016) | Boston Scientific Scimed, Inc. | 2002-07-31 |
| NOVOSTE(TM) BETA-CATH SYSTEM (P000018/S023) | Best Vascular, Inc. | 2002-07-31 |
| ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V-235) (P910023/S061) | ABBOTT MEDICAL | 2002-07-30 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S004) | Carbon Medical Technologies, Inc. | 2002-07-30 |
| ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V-235) (P880086/S088) | ABBOTT MEDICAL | 2002-07-30 |
| ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235) (P830045/S081) | St. Jude Medical, Inc. | 2002-07-30 |
| NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S042) | LivaNova USA, Inc. | 2002-07-29 |
| PERFLUORON (P950018/S008) | Alcon Laboratories | 2002-07-29 |
| MEDTRONIC ACTIVA PARKINSON CONTROL SYSTEM (P960009/S024) | Medtronic, Inc. | 2002-07-29 |
| COMBI 40+COCHLEAR IMPLANT SYSTEM,C40+S(COMPRESSED)ELECTRODE ARRAY/C40+ GB (SPLIT) ELECTRODE ARRAY (P000025/S001) | Med-El Corp. | 2002-07-29 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S001) | Cryolife, Inc. | 2002-07-29 |
| BIODIVYSIO SV OTW PHOSPHORYLCHOLINE COATED STENT DELIVERY SYSTEM (P000011/S006) | Abbott Vascular, Inc. | 2002-07-26 |
| IMMULITE 2000 XPI HBSAG (P010050) | Siemens Healthcare Diagnostics Products, Ltd. | 2002-07-26 |
| IMMULITE 2000 XPI ANTI-HBC IMG (P010053) | Siemens Healthcare Diagnostics Products, Ltd. | 2002-07-26 |