| CONSULTIVA CASE INPUT STATION, MODEL CIS-1 (K031132) | Eastman Kodak Company | 2003-11-26 |
| BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (K033070) | Trinity Biotech USA | 2003-11-26 |
| KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 (K032087) | Keeler Instruments, Inc. | 2003-11-26 |
| DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE (K033281) | Datex-Ohmeda | 2003-11-26 |
| REFLECTION CONSTRAINED LINER (K033442) | Smith & Nephew, Inc. | 2003-11-26 |
| LEGIONELLA PNEUMOPHILA IGG/IGM (K033051) | Trinity Biotech USA | 2003-11-26 |
| MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) (K033482) | Dade Behring, Inc. | 2003-11-26 |
| RHYTHM DIGITAL ELECTRONIC STETHOSCOPE (K032230) | Thinklabs, Inc. | 2003-11-26 |
| HERPES GROUP IGG (K033059) | Trinity Biotech, Inc. | 2003-11-26 |
| GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER (K031524) | Varian Medical Systems, Inc. | 2003-11-26 |
| HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER (K033294) | C.R. Bard, Inc. | 2003-11-26 |
| MYCOPLASMA IGG (K033064) | Trinity Biotech USA | 2003-11-26 |
| FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER (K033561) | Fujifilm Medical System U.S.A., Inc. | 2003-11-26 |
| CHLAMYDIA IGG ELISA TEST SYSTEM (K033079) | Trinity Biotech USA | 2003-11-26 |
| BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (K033083) | Trinity Biotech USA | 2003-11-26 |
| SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS (K033411) | Synthes (Usa) | 2003-11-26 |
| CEMSTOP CEMENT RESTRICTOR (K032685) | Teknimed, S.A. | 2003-11-26 |
| AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 (K033292) | Igc-Medical Advances, Inc. | 2003-11-26 |
| RENOVA INTERNAL HEX IMPLANT SYSTEM (K032774) | Lifecore Biomedical, Inc. | 2003-11-26 |
| ORTHOSPHERE CERAMIC SPHERICAL IMPLANT (K030319) | Wrightmedicaltechnologyinc | 2003-11-26 |
| OPTIMESH (K014200) | Spineology, Inc. | 2003-11-26 |
| PYLORI IGG (K033067) | Trinity Biotech USA | 2003-11-26 |
| FOSSA URETERAL OPEN LUMEN STENT (K033368) | Fossa Medical, Inc. | 2003-11-26 |
| NXSTAGE PUREFLOW SOLUTION (K033386) | Nxstage Medical, Inc. | 2003-11-26 |
| JSA REPROCESSED COMPRESSION SLEEVE DEVICES (K031722) | Jack Speer and Assoc., Inc. | 2003-11-25 |
| DRAEGER MICRO2+ AND MASIMO MINISAT (K032537) | Draeger Medical Systems, Inc. | 2003-11-25 |
| AXIOM BIOLASER LLLT SERIES-3 (K033015) | Axiom Usa., Inc. | 2003-11-25 |
| SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO (K031340) | Siemens Medical Solutions USA, Inc. | 2003-11-25 |
| CAPHOSOL (K030802) | Inpharma A.S. | 2003-11-25 |
| MDIFICATION TO MEDIPRIME (K033013) | Algotec Systems, Ltd. | 2003-11-25 |
| GRANDIO FLOW (K033117) | Voco GmbH | 2003-11-25 |
| LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS (K033335) | Siemens Medical Solutions USA, Inc. | 2003-11-25 |
| ATR 5000, LC 5000, IMPLANT SYSTEM (K033597) | Advanced Technology Research (A.T.R.) S.R.L. | 2003-11-25 |
| MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS (K033567) | Mri Devices Corp. | 2003-11-25 |
| MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM (K031997) | Mallinckrodt Dar S.R.L. | 2003-11-25 |
| GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (K033504) | General Electric Co. | 2003-11-25 |
| MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 (K031153) | Arrow Intl., Inc. | 2003-11-25 |
| SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS (K033554) | Gyrus Ent LLC | 2003-11-24 |
| MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM (K033492) | Ge Medical Systems Information Technologies | 2003-11-24 |
| CEDIA VANCOMYCIN ASSAY (K032811) | Microgenics Corp. | 2003-11-24 |
| BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG (K032713) | Boston Biomedica, Inc. | 2003-11-24 |
| ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER (K033548) | Roche Diagnostics Corp. | 2003-11-24 |
| IMMUNICON CELLTRACKS ANALYZER (K030263) | Immunicon Corp. | 2003-11-24 |
| GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML (K031419) | Laboratorios Grifols, S.A. | 2003-11-24 |
| SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE (K032598) | Synergetics, Inc. | 2003-11-24 |
| HBA SPERM-HYALURONAN BINDING ASSAY (K032874) | Biocoat, Inc. | 2003-11-24 |
| ELECTRO FLO PERCUSSOR, MODEL 5000 (K031876) | Med Systems | 2003-11-21 |
| PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER (K033444) | Philips Medical Systems | 2003-11-21 |
| ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP (K033041) | ACON Laboratories, Inc. | 2003-11-21 |
| BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER (K033441) | Boston Scientific Corp | 2003-11-21 |
| SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K031842) | Intra Luminal Therapeutics, Inc. | 2003-11-21 |
| LMT NOMAG IC 1,5 (K033565) | Lmt Lammers Medical Technology GmbH | 2003-11-21 |
| OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 (K032665) | Olympus America, Inc. | 2003-11-21 |
| CONTEC DUO, CONTEC LC, CONTEC LCR (K030644) | Dentaurum | 2003-11-21 |
| UNIMARK HOME PREGNANCY TEST DEVICE (K032992) | Biotech Atlantic, Inc. | 2003-11-21 |
| PROTEMP 3 GARANT (K033022) | 3M Espe AG Dental Products | 2003-11-21 |
| AERONEB GO NEBULIZER, MODEL AG-AG2000 (K032849) | Aerogen, Inc. | 2003-11-21 |
| PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM (K033314) | Ev3, Inc. | 2003-11-21 |
| ARAMIS II DERMATOLOGICAL LASER (K032260) | Quantel Medical | 2003-11-20 |
| OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E (K023452) | Canopus Medical Supply Co., Ltd. | 2003-11-20 |
| DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) (K032331) | Pro-Med Instruments GmbH | 2003-11-20 |
| NEUROLASE, MODELS 150V, 150C, 1064 (K032787) | Spectrum Laser & Technologies | 2003-11-20 |
| BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE (K032940) | Brightway Holdings Sdn. Bhd. | 2003-11-20 |
| GROWTH GUIDANCE PLATE (K031493) | University of Utah/School of Medicine | 2003-11-20 |
| SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL) (K032995) | Micron Corp. | 2003-11-20 |
| UCR SPINAL SYSTEM (K032739) | Seaspine | 2003-11-20 |
| VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE (K033237) | Vascular Solutions, Inc. | 2003-11-20 |
| MODIFICATION TO RESQPOD CIRCULATORY ENHANCER (K033401) | Advanced Circulatory Systems, Inc. | 2003-11-20 |
| PLV CONTINUUM VENTILATOR, MODEL P1000 (K022750) | Respironics California, Inc. | 2003-11-20 |
| EPI-SCAN, MODEL P 100 (K032935) | Edx Epi-Scan, Inc. | 2003-11-20 |
| DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE (K033057) | Deroyal | 2003-11-20 |
| BI-ANGULAR SHOULDER SYSTEM (K032895) | Biomet, Inc. | 2003-11-20 |
| FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K032908) | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 2003-11-20 |
| TLC MODELS ULK-H AND ULT-H INFRARED LAMPS (K033035) | Tlc Marketing, Inc. | 2003-11-20 |
| CALCIGEN PSI BONE GRAFT SUBSTITUTE (K032286) | Biomet Orthopedics, Inc. | 2003-11-20 |
| BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000 (K033438) | Bruno Independent Living Aids, Inc. | 2003-11-20 |
| SYSTEM 100 ULTRAFILTRATION CATHETER (K023874) | Chf Solutions, Inc. | 2003-11-20 |
| HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q (K031676) | Baxter Healthcare Corp | 2003-11-20 |
| SCORPIO NRG KNEE SYSTEM (K030978) | Howmedica Osteonics Corp. | 2003-11-20 |
| FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES (K032907) | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 2003-11-20 |
| QUASAR, MODEL MD21 (K032379) | Quantum Skincare, Inc. | 2003-11-20 |
| LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ (K033431) | Cti Pet Systems, Inc. | 2003-11-20 |
| NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2) (K023537) | Sgmp Co., Ltd. | 2003-11-20 |
| MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) (K033501) | Roche Diagnostics Corp. | 2003-11-20 |
| BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER (K032938) | Brightway Holdings Sdn. Bhd. | 2003-11-20 |
| ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS (K030958) | Ortho Tec, LLC | 2003-11-20 |
| BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 (K031375) | Besmed Health Business Corp | 2003-11-20 |
| PLASTALGIN AND PLASTALGIN ORTHO (K032708) | Septodont | 2003-11-20 |
| REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS (K033593) | Clearmedical, Inc. | 2003-11-20 |
| LIGHTSPEED 6.0 CT SCANNER SYSTEM (K033502) | Ge Medical Systems, LLC | 2003-11-20 |
| TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE (K032613) | Peter M. Rothenberg, M.D. | 2003-11-20 |
| COOK CODA BALLOON CATHETER (K032869) | Cook, Inc. | 2003-11-19 |
| THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ (K033384) | Implex Corp. | 2003-11-19 |
| TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 (K033188) | Idev Technologies, Inc. | 2003-11-19 |
| SPEEDLYSER INFUSION CATHETER KIT (K033443) | AngioDynamics, Inc. | 2003-11-19 |
| GE PRECISION MPI (K033486) | Nrt-Nordisk Rontgen Teknik A/S | 2003-11-19 |
| AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS (K033345) | Analogic Corp. | 2003-11-19 |
| SCOUT PRO (K033320) | Biotronik, Inc. | 2003-11-19 |
| HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III (K032802) | Hk Surgical, Inc. | 2003-11-19 |
| INTERLAB IMMUNOFIXATION TEST(S) (K033187) | Interlab S.R.L. | 2003-11-19 |