| SE INFUSION SYSTEM WITH MMS (K043590) | Cardinal Health, Alaris Products | 2005-03-25 |
| PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES (K050295) | Helio Medical Supplies, Inc. | 2005-03-25 |
| MRIDIUM 3850 MRI PUMP SYSTEM (K050301) | Iradimed Corporation | 2005-03-24 |
| MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS (K050591) | Raven Biological Laboratories, Inc. | 2005-03-23 |
| TEMPTOUCH DERMAL THERMOMETER (K050137) | Xilas Medical, Inc. | 2005-03-18 |
| POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL (K050527) | Spi Gloves Sdn. Bhd. | 2005-03-18 |
| POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE) (K050531) | Spi Gloves Sdn. Bhd. | 2005-03-18 |
| ACCU-CHEK SPIRIT (K042887) | Disetronic Medical Systems AG | 2005-03-18 |
| NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) (K050214) | Hartalega Sdn Bhd | 2005-03-16 |
| POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER (K050529) | Spi Gloves Sdn. Bhd. | 2005-03-16 |
| POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) (K050530) | Spi Gloves Sdn. Bhd. | 2005-03-16 |
| NITRILE POWDERED EXAMINATION GLOVES (WHITE) (K050215) | Hartalega Sdn Bhd | 2005-03-11 |
| BODYGUARD INFUSION PUMP SYSTEM (K042696) | Caesarea Medical Electronics , Ltd. | 2005-03-11 |
| HARVEST GRAFT DELIVERY SYRINGE (K043261) | Harvest Technologies, Corp. | 2005-03-11 |
| VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE (K042952) | Zibo Hengchang Plastic & Rubber Products Co., Ltd. | 2005-03-10 |
| PRE-POWDERED VINYL EXAM GLOVES (K042951) | Zibo Hengchang Plastic & Rubber Products Co., Ltd. | 2005-03-10 |
| POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K043478) | Shijaizhuang Brilliant Ocean Plastic Co., Ltd. | 2005-03-09 |
| DRAGON HEART I.V. SET (K043235) | Dragon Heart Medical Devices Co., Ltd. | 2005-03-08 |
| YIXIN SAFETY SYRINGE (K042102) | Jiangxi Sanxin (Eversincere) Medical Devices Group | 2005-03-08 |
| DIGITAL FOREHEAD THERMOMETER, MODEL FS-100 (K043331) | Hubdic Co., Ltd. | 2005-03-04 |
| 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X. (K050303) | Mesure Technology Co., Ltd. | 2005-02-25 |
| SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE (K050339) | Laboratorios Grifols, S.A. | 2005-02-25 |
| VORTEX EZ VASCULAR ACCESS PORT (K050176) | Rita Medical Systems, Inc. | 2005-02-25 |
| DUREX PLAY WARMER LUBRICANT (K042563) | Ssl Americas, Inc. | 2005-02-23 |
| DUOPROSS SYRINGES (K042500) | Duopross Meditech Corporation | 2005-02-22 |
| FERRIS POLYMEM STERILE BREAST PAD (K031660) | Ferris Mfg. Corp. | 2005-02-22 |
| PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE (K043490) | Vidacare Corporation | 2005-02-18 |
| PERSONAL INJECTOR (K033696) | Union Medico Aps | 2005-02-16 |
| TURBO TEMP TRIO (K050230) | Cardinal Health, Alaris Products | 2005-02-16 |
| 8NONE (K041839) | Medical Solutions, Inc. | 2005-02-15 |
| ACUPUNCTURE NEEDLES (K043506) | Marknew Products | 2005-02-11 |
| HARVARD 2 SYRINGE PUMP, MODEL 2001-001 (K050107) | Harvard Clinical Technology | 2005-02-11 |
| C&G ACUPUNCTURE NEEDLE (K043277) | Helio Medical Supplies, Inc. | 2005-02-08 |
| PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE (K050152) | Dipped Products (Thailand), Ltd. | 2005-02-07 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K050154) | Zibo Zhuangyuan Plastic & Rubber Co., Ltd. | 2005-02-07 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K050155) | Zibo Zhuangyuan Plastic & Rubber Co., Ltd. | 2005-02-07 |
| POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K043499) | Shijaizhuang Brilliant Ocean Plastic Co., Ltd. | 2005-02-04 |
| EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER (K043446) | Emmebi Srl | 2005-02-04 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K043475) | Shijiazhuang Winful Plastic Co., Ltd. | 2005-02-01 |
| POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS) (K043014) | Shijiazhuang Tillotson Rubber Products Co., Ltd. | 2005-01-28 |
| F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK (K042129) | Cedic S.R.L. | 2005-01-27 |
| PROCEDUR 10 SYRINGE DEVICE (K042486) | Avanca Medical Devices, Inc. | 2005-01-21 |
| PROCEDUR SF SAFETY SYRINGE DEVICE (K042487) | Avanca Medical Devices, Inc. | 2005-01-21 |
| OCEAN CHEST DRAIN (K043582) | Atrium Medical Corp. | 2005-01-21 |
| PANTHERA N POWDER FREE BLACK NITRILE GLOVES (K042898) | Glovco (M) Sdn. Bhd. | 2005-01-18 |
| Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 (K043304) | Bioject Medical Technologies, Inc. | 2005-01-14 |
| 6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC (K043502) | C.R. Bard, Inc. | 2005-01-14 |
| NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING (K042879) | Sgmp Co., Ltd. | 2005-01-13 |
| SPSMEDICAL SPORVIEW PA CULTURE SET (K043135) | Spsmedical Supply Corp. | 2005-01-13 |
| TRUGRAFT BGS SYRINGE, MODEL 600-041 (K043172) | Osteobiologics, Inc. | 2005-01-07 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K043477) | Shijiazhuang Winful Plastic Co., Ltd. | 2005-01-07 |
| PHARMGUARD TOOLBOX, MODEL G6000782 (K042432) | Medex, Inc. | 2005-01-04 |
| IXL-II DIABETES MANAGEMENT SYSTEM (K042792) | Insulet Corporation | 2005-01-03 |
| MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE (K043397) | Becton, Dickinson & CO | 2004-12-29 |
| ACUPUNCTURE NEEDLES (K041652) | C.A.I. Industries Corp. | 2004-12-29 |
| CLINICAL ELECTRONIC THERMOMETER (K032434) | Cotronic Manufacturing | 2004-12-27 |
| EAR THERMOMETER, MODEL WL-320X (K042631) | Innovatech, Inc. | 2004-12-22 |
| BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML (K043038) | Biotop Technology Co., Ltd. | 2004-12-22 |
| NEOSCI MEDICAL ENDOLUMINAL BRUSH (K030400) | Neosci Medical, Inc. | 2004-12-22 |
| NEEDLE INCAPACITATOR (NEEDLE GUARD) (K042907) | Pdmp, Inc. | 2004-12-22 |
| LUTH-ALL SUB-Q NEEDLE SET (K042666) | Luth-All Medical Products, LLC | 2004-12-21 |
| THE RELIANCE PI PROCESS INDICATOR, MODEL D5116 (K043482) | STERIS Corporation | 2004-12-21 |
| CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER (K041038) | Churchill Medical Systems, Inc. | 2004-12-21 |
| POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K043159) | Shijaizhuang Brilliant Ocean Plastic Co., Ltd. | 2004-12-20 |
| FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE (K042239) | Pt. Mandiri Inti Buana | 2004-12-16 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE (K042805) | Perusahaan Getah Asas Sdn. Bhd. | 2004-12-16 |
| REUSABLE STERILCONTAINER FILTER MODEL #JK090 (K041623) | Aesculap, Inc. | 2004-12-13 |
| ANIMAS MODEL IR1250 INSULIN INFUSION PUMP (K042873) | Animas Corp. | 2004-12-10 |
| CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER (K041833) | Consolidated Machine Corp. | 2004-12-10 |
| KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 (K042461) | Kendall | 2004-12-10 |
| MEDLEY PCA MODULE, MODEL 8120 (K043299) | Alaris Medical Systems, Inc. | 2004-12-10 |
| IR VIEWER (K042679) | Infrared Imaging Systems, Inc. | 2004-12-10 |
| CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093 (K042588) | Confluent Surgical,Inc | 2004-12-09 |
| MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1 (K043110) | Microlife Intellectual Property GmbH | 2004-12-09 |
| STRYKER CASSETTE PUMP (K042454) | Stryker Endoscopy | 2004-12-09 |
| AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER (K040865) | Aesculap | 2004-12-06 |
| MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) (K042817) | Ansell Healthcare Products, Inc. | 2004-12-06 |
| HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 (K043256) | Hospira, Inc. | 2004-12-06 |
| BD ONECATH (K042862) | Becton Dickinson Infusion Therapy Systems, Inc. | 2004-12-03 |
| POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE (K041913) | Pt. Medisafe Technologies | 2004-12-01 |
| MODIFICATION TO D-TRONPLUS (K043000) | Disetronic Medical Systems AG | 2004-12-01 |
| VASCULAR SOLUTIONS SCLERO-KIT (K043019) | Vascular Solutions, Inc. | 2004-12-01 |
| DRAGON HEART PISTON SYRINGE (K042547) | Dragon Heart Medical Devices Co., Ltd. | 2004-12-01 |
| PUMP CONNECTIVITY INTERFACE (K040985) | Baxter Healthcare Corp | 2004-11-30 |
| POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING (K042645) | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2004-11-26 |
| MEDTRADE PRODICT'S SOOTHING GEL PATCH (K030901) | Medtrade Products , Ltd. | 2004-11-26 |
| PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP (K042653) | Pack & Proper Co., Ltd. | 2004-11-26 |
| LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) (K042618) | La Glove (M) Sdn. Bhd. | 2004-11-26 |
| NEXUS INTRAVENOUS TUBING SETS (NIVTS) (K041861) | Nexus Medical, LLC | 2004-11-26 |
| SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE (K042936) | Baxter Healthcare Corp | 2004-11-26 |
| SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE (K042314) | Biogen | 2004-11-22 |
| BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER (K042491) | Becton, Dickinson & CO | 2004-11-22 |
| AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 (K042906) | Amplife Corporation | 2004-11-19 |
| HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE (K042980) | Hospira, Inc. | 2004-11-17 |
| TIDI BRAND STERILIZATION WRAP (K042580) | Banta Healthcare Group, Ltd. | 2004-11-17 |
| POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES (K042830) | Grand Work Plastic Products Co., Ltd. | 2004-11-17 |
| BEELINE MOTIV, PROPOLIS, PCA (K042228) | Mckinley, Inc. | 2004-11-08 |
| GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 (K041239) | Genesis Medical Technology, Inc. | 2004-11-08 |
| INNOJECT AUTO-INJECTOR (K042557) | Innoject, Inc. | 2004-11-08 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES (K042120) | Shijiazhuang Manful Light Industrial Products Co., | 2004-11-04 |