| HDL-EX SEIKEN ASSAY KIT (K041090) | Denka Seiken Co., Ltd. | 2004-10-29 |
| DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT (K042448) | General Atomics | 2004-10-29 |
| CENTURION SES EPIKERATOME (K042810) | Norwood Abbey , Ltd. | 2004-10-28 |
| VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE (K042006) | Ortho-Clinical Diagnostics, Inc. | 2004-10-28 |
| GELATO PROPHYLAXIS PASTE (K042048) | Deepak Products, Inc. | 2004-10-26 |
| CROMAX HIGH SPEED TURBINE HANDPIECE (K041755) | J.R. Medical Technologies, Inc. | 2004-10-22 |
| SMARTMIX PRE-FILLED MIXING SYSTEM (K042591) | DePuy Orthopaedics, Inc. | 2004-10-22 |
| LITESTREAM 500E (K042444) | Pride Mobility Products Corp. | 2004-10-21 |
| OPTIMA MX (K042759) | Bien-Air SA Switzerland | 2004-10-20 |
| IBD-SCAN (K042071) | Techlab, Inc. | 2004-10-20 |
| MI PASTE (K042200) | GC America, Inc. | 2004-10-20 |
| JEJE TEETHER (K034017) | Vibe 2000 | 2004-10-18 |
| VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 (K041975) | Maine Standards Co. | 2004-10-15 |
| MB 105 MILLENNIUM BLADES (K041110) | Millennium Biomedical, Inc. | 2004-10-13 |
| LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 (K042324) | Bio-Rad | 2004-10-07 |
| VARI-ABLE APB (ADAPTABLE POSITIONING BASE) (K042401) | American Track Roadsters, Inc. | 2004-10-07 |
| DELFIA NEONATAL 17A-OH-PROGESTERONE KIT (K042424) | Wallac OY | 2004-09-30 |
| AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (K042425) | Wallac OY | 2004-09-30 |
| SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY (K042226) | Syntex Healthcare Products Co., Ltd. | 2004-09-30 |
| ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) (K041866) | Axis-Shield Diagnostics, Ltd. | 2004-09-29 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS (K042303) | Ortho-Clinical Diagnostics | 2004-09-27 |
| LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM (K041349) | Ibl GmbH | 2004-09-24 |
| IMPLANTEO IMPLANTOLOGY MOTOR (K041279) | Anthogyr | 2004-09-23 |
| MICROSCOPE SYSTEM (K041805) | Miras Mirror Imaging Solutions, Ltd. | 2004-09-21 |
| CAVERMAP SURGICAL AID (K041732) | Blue Torch Medical Technologies | 2004-09-21 |
| NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE (K042378) | Shijiazhuang Tillotson Rubber Products Co., Ltd. | 2004-09-20 |
| ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 (K042335) | Bio-Rad Laboratories, Inc. | 2004-09-17 |
| READY-HEAT BLANKET (K042145) | Techtrade, LLC | 2004-09-17 |
| SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 (K042195) | Beckman Coulter, Inc. | 2004-09-16 |
| CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (K042238) | Seal Polymer Industries Bhd. | 2004-09-16 |
| MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE (K041437) | Terang Nusa Sdn Bhd | 2004-09-16 |
| EPITOME SYSTEM (K041206) | Gebauer Medizintechnik GmbH | 2004-09-15 |
| POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES (K042214) | Shandong Perfect Plastic Co., Ltd. | 2004-09-15 |
| MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA (K042389) | Roche Diagnostics Corp. | 2004-09-14 |
| CHIN-UP STRIP (K040491) | Dale Miller, Inc. - the Chin-Up Company | 2004-09-10 |
| MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT (K041381) | Medtronic Xomed, Inc. | 2004-09-10 |
| PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES (K042213) | Shandong Perfect Plastic Co., Ltd. | 2004-09-09 |
| RANDOX TRI LEVEL CARDIAC CONTROL (K041361) | Randox Laboratories Limited | 2004-09-09 |
| CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 251 (K042304) | Spectris Technologies, Inc. | 2004-09-08 |
| SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE (K042247) | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | 2004-09-02 |
| PRE-POWDERED VINYL EXAM GLOVES (K041379) | Shijiazhuang Wally Plastics Co., Ltd. | 2004-08-31 |
| ACCLAIM (K042266) | Air Techniques, Inc. | 2004-08-31 |
| CARRIAZO PENDULAR (K032910) | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2004-08-30 |
| CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES (K042101) | Seal Polymer Industries Bhd. | 2004-08-27 |
| VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II (K041720) | Ortho-Clinical Diagnostics, Inc. | 2004-08-25 |
| MARE DENTAL OPERATIVE UNIT (K041458) | Denimed Electronica S.H. | 2004-08-24 |
| BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN (K041371) | Novamin Technology, Inc. | 2004-08-23 |
| POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR (K041848) | Pt. Smartglove Indonesia | 2004-08-20 |
| SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2 (K041436) | Terang Nusa Sdn Bhd | 2004-08-20 |
| POWDER-FREE NITRILE EXAMINATION GLOVES (K041276) | Shanghai Motex Healthcare Co., Ltd. | 2004-08-20 |
| IMMUNOCARD TOXINS A & B, MODEL 712050 (K041003) | Meridian Bioscience, Inc. | 2004-08-20 |
| POWDER-FREE BLUE VINYL EXAM GLOVES (K041945) | Glormed Intl., Inc. | 2004-08-20 |
| TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM (K042080) | Home Diagnostics, Inc. | 2004-08-19 |
| MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY (K041995) | Uresil, LLC | 2004-08-19 |
| COCOON HYGIENIST (K040529) | Satelec | 2004-08-19 |
| SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT (K041643) | Beckman Coulter, Inc. | 2004-08-18 |
| ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR (K041687) | Abbott Laboratories | 2004-08-18 |
| DC-ACETA/SAL CONTROLS (K041666) | Diagnostic Chemicals , Ltd. | 2004-08-17 |
| OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN (K040108) | Est International Corporation | 2004-08-17 |
| INTERLAB MICROCAL SERUM CONTROLS (K041871) | Trouble Shooter Consuling, Inc. | 2004-08-16 |
| ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H (K041194) | Medical Analysis Systems, Inc. | 2004-08-16 |
| CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM (K041898) | Cliniqa Corporation | 2004-08-16 |
| IMMUNOCARD STAT! RSV MODEL #750630 (K041445) | Meridian Bioscience, Inc. | 2004-08-13 |
| POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) (K040792) | Pt. Smartglove Indonesia | 2004-08-12 |
| XPS CURVED BUR (K041985) | Medtronic Xomed, Inc. | 2004-08-12 |
| HANSON SCAR ADE (K040307) | Hanson Medical, Inc. | 2004-08-12 |
| ALCOMATE, MODEL CA2000 (K041334) | Khn Solutions, LLC | 2004-08-11 |
| VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE (K042028) | Zibo Borui Plastic & Rubber Products Co., Ltd. | 2004-08-09 |
| NIGHTFORM (K041996) | Plastic Surgery Solutions, LLC | 2004-08-03 |
| SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE (K040682) | Grand Work Plastic Products Co., Ltd. | 2004-07-28 |
| MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) (K041812) | Roche Diagnostics Corp. | 2004-07-27 |
| SINON SN-L402 LIGHTWEIGHT WHEELCHAIR (K041465) | Sinon Corporation | 2004-07-23 |
| LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA (K040923) | Ibl GmbH | 2004-07-22 |
| FS SERIES WHEELCHAIR (K041814) | Foshan Dongfang Medical Equipment Manufactory(Ltd) | 2004-07-20 |
| MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES (K041338) | Medtronic Vascular | 2004-07-19 |
| MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM (K033897) | Aga-Linde Health Care | 2004-07-19 |
| OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 (K041793) | Olympus America, Inc. | 2004-07-16 |
| SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED (K041225) | Grand Work Plastic Products Co., Ltd. | 2004-07-15 |
| POCONE INFRARED SPECTROPHOTOMETER (K041148) | Otsuka Pharmaceutical Co., Ltd. | 2004-07-15 |
| VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR (K041745) | Arista Latindo Industrial Ltd. P.T | 2004-07-15 |
| FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (K041391) | Hartalega Sdn Bhd | 2004-07-09 |
| POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K040841) | Medline Industries, Inc. | 2004-07-08 |
| ZIRCON-F PROPHYLAXIS PASTE (K040988) | Pascal Co., Inc. | 2004-07-07 |
| LIQUICHEK WHOLE BLOOD VOLATILES CONTROL (K041561) | Bio-Rad | 2004-07-06 |
| TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS (K040459) | Biosite Incorporated | 2004-07-06 |
| PTS PANELS LDL CHOLESTEROL TEST STRIPS (K040693) | Polymer Technology Systems, Inc. | 2004-07-06 |
| ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE) (K041004) | Purna Bina Sdn Bhd | 2004-07-02 |
| SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 (K040416) | Philips Oral Healthcare, Inc. | 2004-07-02 |
| DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE (K041325) | Est International Corporation | 2004-07-02 |
| NASALCEASE (K041446) | Les Laboratorires Brothier, S.A. | 2004-07-01 |
| IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES (K040674) | Anthogyr | 2004-06-30 |
| ELASTIC SKIN LIQUID BANDAGE (K032948) | Medpak, LLC | 2004-06-25 |
| POWDER FREE LATEX EXAMINATION GLOVES (K033533) | Apl International Incorporated Limited | 2004-06-24 |
| POWDERED LATEX SURGEON'S GLOVES (K031368) | Cephas Medical Private , Ltd. | 2004-06-22 |
| M3 MICROKERATOME (K032836) | Moria SA | 2004-06-18 |
| PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE (K033785) | Discus Dental, Inc. | 2004-06-18 |
| FSH MENOPAUSE PREDICTOR TEST (K041165) | ACON Laboratories, Inc. | 2004-06-17 |
| MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE (K040837) | Medicel AG | 2004-06-17 |
| DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES (K040967) | Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd. | 2004-06-16 |
| RANDOX IMMUNOASSAY CONTROL (K040379) | Randox Laboratories, Ltd. | 2004-06-16 |