| GYNECARE INTERGEL ADHESION PREVENTION SOLUTION (P990015/S002) | Lifecore Biomedical, Inc. | 2003-03-18 |
| COSEAL SURGICAL SEALANT (P010022/S002) | Angiotech Medical Device Technologies | 2003-03-18 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRP+/TEMPO+ SPEECH PROCESSORS (P000025/S006) | Med-El Corp. | 2003-03-18 |
| STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS (P000046/S006) | Anika Therapeutics, Inc. | 2003-03-18 |
| QUANTIFERON-TB (P010033/S003) | Qiagen | 2003-03-17 |
| NOVOSTE BETA-CATH 3.5 SYSTEM (P000018/S031) | Best Vascular, Inc. | 2003-03-17 |
| OSTEONICS ABC/TRIDENT SYSTEMS (P000013/S001) | Howmedica Osteonics Corp. | 2003-03-17 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S014) | Vascular Solutions, Inc. | 2003-03-14 |
| NEEDLE ZAP (R) (P010065) | E Med Future | 2003-03-14 |
| DIASORIN HBSAG CONFIRMATORY TEST (P990038/S004) | DiaSorin, Inc. | 2003-03-14 |
| SYNVISC (HYLAN G-F 20) (P940015/S009) | Sanofi Genzyme Corp. | 2003-03-14 |
| HEALTHTRONICS OSSATRON (P990086/S003) | Sanuwave, Inc. | 2003-03-14 |
| IMMULITE, IMMULITE 1000 ANTI-HBC AND IMMULITE 2000 ANTI-HBC (P010053/S001) | Siemens Healthcare Diagnostics Products, Ltd. | 2003-03-13 |
| IMMULITE, IMMULITE 1000 ANTI-HBS AND IMMULITE 2000 ANTI-HBS (P010052/S001) | Siemens Healthcare Diagnostics Products, Ltd. | 2003-03-13 |
| IMMULITE,IMMULITE 1000 HBSAG,CONFIRMATORY AND IMMULITE 2000 HBSAG,CONFIRMATORY KIT (P010050/S001) | Siemens Healthcare Diagnostics Products, Ltd. | 2003-03-13 |
| IMMULITE, IMMULITE 1000 ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBCIGM (P010051/S001) | Siemens Healthcare Diagnostics Products, Ltd. | 2003-03-13 |
| NOVOSTE BETA-CATH 3.5 SYSTEM (P000018/S032) | Best Vascular, Inc. | 2003-03-13 |
| STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS (P000046/S007) | Anika Therapeutics, Inc. | 2003-03-12 |
| QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM (P010049/S005) | Sub-Q, Inc. | 2003-03-12 |
| MCGHAN SALINE-FILLED BREAST IMPLANTS (P990074/S014) | Allergan | 2003-03-12 |
| EXPRESS/EXPRESS2 MR/OTW CORONARY STENT SYSTEM (P020009/S006) | Boston Scientific Scimed, Inc. | 2003-03-12 |
| CUTTING BALLOON (P950020/S006) | Boston Scientific Corp | 2003-03-11 |
| COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN (P800022/S050) | Allergan | 2003-03-11 |
| SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY (P010034/S002) | Icad, Inc. | 2003-03-07 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S076) | Boston Scientific Corp | 2003-03-07 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S007) | Boston Scientific Scimed, Inc. | 2003-03-07 |
| MENTOR SALINE-FILLED BREAST IMPLANTS (P990075/S010) | Mentor Worldwide, LLC | 2003-03-07 |
| ICAD (P010038/S003) | Icad, Inc. | 2003-03-06 |
| ESSURE SYSTEM (P020014/S001) | Bayer Pharma AG | 2003-03-06 |
| FRESHLOOK DIMENSIONS (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/6 NIGHTS (SPHERICAL (P830037/S048) | Alcon Laboratories, Inc. | 2003-03-06 |
| LIPOSORBER LA-15 SYSTEM (P910018/S007) | Kaneka Pharma America Corp. | 2003-03-06 |
| MODEL 7230 MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980016/S031) | Medtronic Cardiac Rhythm Disease Management | 2003-03-06 |
| AFP CONTROL PACK (P820060/S017) | Abbott Laboratories | 2003-03-05 |
| GENESIS NEUROSTIMULATION (IPG) SYSTEM (P010032/S007) | ABBOTT MEDICAL | 2003-03-05 |
| NC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER (P790017/S079) | Medtronic, Ireland | 2003-03-04 |
| IMAGECHECKER (P970058/S015) | Hologic, Inc. | 2003-03-04 |
| MEDTRONIC ATAKR II MODEL 4802 (60W) SOFTWARE VERSION 1.36 (P930029/S020) | Medtronic, Inc. | 2003-03-03 |
| DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR (P860026/S008) | Avery Biomedical Devices, Inc. | 2003-03-03 |
| ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS (P850048/S019) | Beckman Coulter, Inc. | 2003-03-03 |
| NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S045) | LivaNova USA, Inc. | 2003-02-28 |
| IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA (P930027/S005) | Siemens Healthcare Diagnostics, Inc. | 2003-02-28 |
| ACCESS HYBRITECH FREE PSA ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (P970038/S007) | Beckman Coulter, Inc. | 2003-02-28 |
| STINGER, STINGER S, STINGER M, AND STINGER SM ABLATION CATHETER (P000020/S008) | Boston Scientific Corp | 2003-02-26 |
| NOVOSTE TM BETA-CATH TM SYSTEM (P000018/S030) | Best Vascular, Inc. | 2003-02-26 |
| MAGIC WALLSTENT ENDOPROSTHESIS SYSTEM (P980009/S012) | Boston Scientific Scimed, Inc. | 2003-02-26 |
| MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA) (P900061/S055) | Medtronic Cardiac Rhythm Disease Management | 2003-02-25 |
| INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE (P010015/S005) | Medtronic, Inc. | 2003-02-25 |
| MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA) (P980035/S026) | Medtronic, Inc. | 2003-02-25 |
| CARDIOMESSENGER HOME MONITORING SYSTEM (P950037/S031) | Biotronik, Inc. | 2003-02-25 |
| MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA) (P980016/S033) | Medtronic Cardiac Rhythm Disease Management | 2003-02-25 |
| TECHNOLAS 217A EXCIMER LASER SYSTEM (P990027/S004) | Technolas Perfect Vision GmbH | 2003-02-25 |
| TENDRIL SDX MODEL 1488T/TC/K (P960013/S011) | ABBOTT MEDICAL | 2003-02-25 |
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHEK (P000027/S002) | Roche Diagnostics Corp. | 2003-02-24 |
| ICAD (P010038/S001) | Icad, Inc. | 2003-02-24 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT/ANTI-HBS CALIBRATORS (P000014/S005) | Ortho-Clinical Diagnostics, Inc. | 2003-02-24 |
| IMMULITE AFP AND IMMULITE 2000 AFP (P010007/S001) | Siemens Healthcare Diagnostics, Inc. | 2003-02-24 |
| DUETT SEALING DEVICE (P990037/S013) | Vascular Solutions, Inc. | 2003-02-21 |
| GEM III AT 7276 (P980050/S013) | Medtronic, Inc. | 2003-02-21 |
| INSYNC IPG 8040 (P010015/S008) | Medtronic, Inc. | 2003-02-21 |
| KAPPA 700/600, 900/800, SIGMA/MEDTRONIC 350 (P980035/S025) | Medtronic, Inc. | 2003-02-21 |
| GEM III DR 7275, GEM III VR 7231, GEM DR 7271 (P980016/S030) | Medtronic Cardiac Rhythm Disease Management | 2003-02-21 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QUICK LOAD (P000049/S006) | Nmt Medical, Inc. | 2003-02-21 |
| INSYNC ICD 7272 (P010031/S004) | Medtronic Cardiac Rhythm Disease Management | 2003-02-21 |
| EXOGEN 3000* LOW INTENSITY FRACTURE HEALING SYSTEM (P900009/S016) | Bioventus, LLC | 2003-02-21 |
| DIVA PLATFORM,DERMA PLATFORM (P990001/S013) | Medtronic, Inc. | 2003-02-21 |
| AMPLATZER SEPTAL OCCLUDER AND AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS (P000039/S004) | ABBOTT MEDICAL | 2003-02-21 |
| GEM MODEL 7227 CX/B/D/E (P900061/S053) | Medtronic Cardiac Rhythm Disease Management | 2003-02-21 |
| KAPPA 400 (P970012/S014) | Medtronic, Inc. | 2003-02-21 |
| HYDRO-THERMABLATOR(HTA) ENDOMETRIAL ABLATION SYSTEM (P000040/S003) | Axora Medical, Inc. | 2003-02-20 |
| LIPOSORBER LA-15 SYSTEM (P910018/S009) | Kaneka Pharma America Corp. | 2003-02-14 |
| SWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD (P980049/S008) | MicroPort CRM USA, Inc. | 2003-02-14 |
| MEDSTONE STS-TC/U LITHOTRIPTER (P970042/S003) | Medstone Intl., Inc. | 2003-02-14 |
| ST.JUDE MEDICAL EPIC/ATLAS DR/VR ICD (P910023/S064) | ABBOTT MEDICAL | 2003-02-12 |
| METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR (P850079/S041) | CooperVision, Inc. | 2003-02-12 |
| PROSORBA COLUMN (P850020/S016) | Fresenius Hemocare, Inc. | 2003-02-12 |
| BLAZER RPM CARDIAC ABLATION CATHETERS (P920047/S018) | Boston Scientific Corp | 2003-02-12 |
| GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S011) | Guidant Corp. | 2003-02-10 |
| QUICKSEAL II ARTERIAL CLOSURE SYSTEM (P010049/S004) | Sub-Q, Inc. | 2003-02-10 |
| MENTOR SALINE-FILLED TESTICULAR PROSTHESIS (P020003/S001) | Coloplast Corp. | 2003-02-05 |
| PRESERVCYT SOLUTION ALTERNATIVE TRANSPORT MEDIUM (P950039/S009) | Hologic, Inc. | 2003-02-05 |
| COSEAL SURGICAL SEALANT (PREMIXED) (P010022/S001) | Angiotech Medical Device Technologies | 2003-02-04 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S006) | Genzyme Corp. | 2003-02-04 |
| CELSIUS AND CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S017) | Biosense Webster, Inc. | 2003-02-04 |
| SILICONE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P990080/S003) | Johnson & Johnson Surgical Vision, Inc. | 2003-02-04 |
| CLARION CII BIONIC EAR SYSTEM (P960058/S029) | Advanced Bionics | 2003-02-04 |
| NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS (P010068/S001) | Biosense Webster, Inc. | 2003-02-04 |
| STORMER BALLOON DILATATION CATHETER WITH ZIPPER DELIVERY (P790017/S078) | Medtronic, Ireland | 2003-02-04 |
| NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S008) | Biosense Webster, Inc. | 2003-02-04 |
| 0.7 MM EXTREME CATHETER (P910001/S021) | Spectranetics Corp. | 2003-02-04 |
| TRIDENT SYSTEM (P000013) | Howmedica Osteonics Corp. | 2003-02-03 |
| CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001) | Ceramtec GmbH | 2003-02-03 |
| INDERMIL TISSUE ADHESIVE (P010002/S003) | Covidien Lp, Formerly Registered AS United States | 2003-01-31 |
| EXCLUDER TM BIFURCATED ENDOPROSTHESIS (P020004/S001) | W. L. Gore & Associates, Inc. | 2003-01-30 |
| DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE SEALING DEVICE (P990037/S012) | Vascular Solutions, Inc. | 2003-01-30 |
| ACCESS AFP REAGENTS ON THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM (P980041/S003) | Beckman Coulter, Inc. | 2003-01-29 |
| MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES (P970042/S004) | Medstone Intl., Inc. | 2003-01-28 |
| BOSTON SCIENTIFIC MAVERICK 2 PTCA CATHETER (P860019/S191) | Scimed Life Systems, Inc. | 2003-01-27 |
| PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES (P790027/S068) | Bausch & Lomb | 2003-01-27 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS (P020027) | Siemens Healthcare Diagnostics | 2003-01-24 |
| EXPRESS AND EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS (P020009/S005) | Boston Scientific Scimed, Inc. | 2003-01-24 |