| ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (K033777) | Syntex Healthcare Products Co., Ltd. | 2004-02-05 |
| BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 (K033538) | Sauter AG | 2004-02-02 |
| ERBE HELIX HYDRO-JET (K033590) | Erbe USA, Inc. | 2004-01-30 |
| ABBOTT DATA PORT PC, MODEL 12181 (K040114) | Abbott Laboratories | 2004-01-29 |
| BD CAREFLOW CENTRAL VENOUS CATHETER (K033500) | Becton, Dickinson & CO | 2004-01-29 |
| ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES (K033532) | Asia Pacific Latex Sdn Bhd | 2004-01-28 |
| ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES (K033530) | Asia Pacific Latex Sdn Bhd | 2004-01-28 |
| SECUMAX BLOOD COLLECTION SYSTEM (K032141) | Tiger Meditech Incorporated | 2004-01-28 |
| DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL (K033381) | Discus Dental, Inc. | 2004-01-27 |
| PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM (K033686) | Smiths Medical MD, Inc. | 2004-01-23 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR (K033835) | Mdm Enterprise Corp. | 2004-01-22 |
| HUBERPRO SAFETY HUBER INFUSION SET (K033515) | Command Medical Products | 2004-01-22 |
| LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001 (K031321) | Medlogic Global Limited | 2004-01-21 |
| 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE (K034031) | M.K. Meditech Co. , Ltd. | 2004-01-21 |
| AMERSHAM HEALTH NEEDLE-GUARD (K033409) | Gettig Pharmaceutical Instrument Co. | 2004-01-21 |
| POLY PER-Q-CATH PICC CATHETERS (K034019) | C.R. Bard, Inc. | 2004-01-21 |
| GROSHONG NXT PICC CATHETERS (K034020) | C.R. Bard, Inc. | 2004-01-21 |
| POWDER-FREE VINYL EXAMINATION GLOVES (K033693) | Shen Wei (Usa), Inc. | 2004-01-16 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR (K033877) | One Touch Products Co., Ltd. | 2004-01-16 |
| POWDERED VINYL EXAMINATION GLOVES (K033692) | Shen Wei (Usa), Inc. | 2004-01-16 |
| MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1 (K034023) | Microlife Intellectual Property GmbH | 2004-01-15 |
| MODIFICATION TO X-PORT DUO PORT (K034065) | C.R. Bard, Inc. | 2004-01-15 |
| INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE (K030739) | Infusion Dynamics, Inc. | 2004-01-14 |
| MODIFICATION TO V-CATH POLY PICC (K033853) | Hdc Corp. | 2004-01-14 |
| SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR (K033683) | Smart Glove Corp. Sdn Bhd | 2004-01-08 |
| MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2 (K033817) | Microlife Intellectual Property GmbH | 2004-01-08 |
| DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR (K033539) | Shen Wei (Usa), Inc. | 2004-01-08 |
| MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU4290 (K033818) | Microlife Intellectual Property GmbH | 2004-01-08 |
| ULTICARE DISPOSABLE SYRINGE 3 ML/CC (K033794) | Ultimed, Inc. | 2003-12-30 |
| GRI-BAG, GRI-BAG AP (K033916) | Laboratorios Grifols, S.A. | 2003-12-30 |
| EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR (K033250) | Edwards Lifesciences, LLC | 2003-12-30 |
| VACUETTE QUICKSHIELD SAFETY TUBE HOLDER (K033478) | Greiner Bio-One Vacuette North America | 2003-12-29 |
| HEPARIN LOCK FLUSH SYRINGE (K032417) | Am2 Pat, Inc. | 2003-12-23 |
| VINYL EXAMINATION GLOVES, POWDERED (K033308) | Tangshan Transocean Plastic Products Co., Ltd. | 2003-12-22 |
| IXL DIABETES MANAGEMENT SYSTEM (K031373) | Insulet Corp. | 2003-12-19 |
| PHOENIX INFANT RADIANT WARMER, MODEL 100NWS (K033040) | International Hospital Supply Co. | 2003-12-17 |
| (MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES (K033229) | Bernard Technologies, Inc. | 2003-12-17 |
| SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE (K033682) | Laboratorios Grifols, S.A. | 2003-12-17 |
| HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (K033054) | Harvard Clinical Technology | 2003-12-16 |
| KACEY INSULIN SYRINGE (K033166) | Kacey, Inc. | 2003-12-12 |
| UP-GRADE FOREHEAD THERMOMETER (K032362) | Medisim, Ltd. | 2003-12-04 |
| LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE (K033576) | Abbott Laboratories | 2003-12-04 |
| CLC2000 CATHETER PATENCY DEVICE (K021692) | Icu Medical, Inc. | 2003-12-04 |
| 9 SECOND DIGITAL THERMOMETER, MODEL BT-S09 (K033082) | Metatech Co., Ltd. | 2003-12-03 |
| FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE (K031818) | Facilai Enterprises , Ltd. | 2003-12-03 |
| GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML (K031419) | Laboratorios Grifols, S.A. | 2003-11-24 |
| LMT NOMAG IC 1,5 (K033565) | Lmt Lammers Medical Technology GmbH | 2003-11-21 |
| OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E (K023452) | Canopus Medical Supply Co., Ltd. | 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 |
| FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K032908) | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 2003-11-20 |
| FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES (K032907) | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 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 |
| 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 |
| BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER (K033350) | Becton, Dickinson & CO | 2003-11-18 |
| MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT (K033473) | Horizon Medical Products, Inc. | 2003-11-18 |
| PARADIGMPAL, MODEL MMT-7330 (K031541) | Minimed, Inc. | 2003-11-18 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA GREEN COLOR (K032670) | Kingswell International, Inc. | 2003-11-14 |
| MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE (K032777) | Nipro Medical Corp. | 2003-11-14 |
| NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY (K032444) | Cardinalhealth | 2003-11-13 |
| BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K032781) | Zibo Blue Sail Plastic & Rubber Products Co., Ltd. | 2003-11-13 |
| POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BROTHERS (K031170) | Long First (Xiamen) Co., Ltd. | 2003-11-13 |
| MPS ACACIA SAFEGUARD HUBER DEVICE (K032934) | Mps Acacia | 2003-11-13 |
| BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES (K032783) | Zibo Blue Sail Plastic & Rubber Products Co., Ltd. | 2003-11-13 |
| MONOJECT INSULIN SYRINGE (K033373) | Tyco Healthcare | 2003-11-13 |
| MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 (K031799) | Miele, Inc. | 2003-11-12 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE (K030583) | Shen Wei (Usa), Inc. | 2003-11-10 |
| AMBIT INTERMITTENT AMBULATORY INFUSION PUMP (K033425) | Sorenson Medical, Inc. | 2003-11-06 |
| AMBIT CONTINUOUS AMBULATORY INFUSION PUMP (K033325) | Sorenson Medical, Inc. | 2003-11-06 |
| INVISIJECT RESUSABLE AUTO-INJECTOR (K032425) | Biogen | 2003-11-05 |
| NIPRO DISPOSABLE SYRINGES (K030683) | Nipro Medical Corp. | 2003-10-31 |
| POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR (K032084) | Shen Wei (Usa), Inc. | 2003-10-29 |
| AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE (K032962) | Arrow Intl., Inc. | 2003-10-29 |
| POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K032024) | Shen Wei (Usa), Inc. | 2003-10-29 |
| PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS (K032119) | Paragon Medical, Inc. | 2003-10-29 |
| MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310 (K032484) | Medtronic Minimed | 2003-10-28 |
| MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313 (K032485) | Medtronic Minimed | 2003-10-28 |
| BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT) (K031928) | Braun GmbH | 2003-10-24 |
| AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER (K031503) | Avita Corporation | 2003-10-24 |
| SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE (K031750) | Kimberly-Clark Corp. | 2003-10-24 |
| DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND GT-205 (K033069) | Tenghi Co., Ltd. | 2003-10-24 |
| DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333 (K032164) | Medtronic Minimed | 2003-10-23 |
| POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED (K032374) | Perusahaan Getah Asas Sdn. Bhd. | 2003-10-22 |
| CARDICARE MODEL MT-301F & MT-301C (K032714) | Lumiscope Co., Inc. | 2003-10-22 |
| SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES (K032746) | Shanghai Giantmax Plastic Product Corp. | 2003-10-17 |
| SHANGHAI GIANTMAX POWDERED CLEAR VINYL EXAMINATION GLOVES (K032745) | Shanghai Giantmax Plastic Product Corp. | 2003-10-17 |
| MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR (K032801) | Albert Browne , Ltd. | 2003-10-17 |
| POWDER FREE LATEX EXAM GLOVES (K031335) | Tan Sin Lian Industries Sdn. Bhd. | 2003-10-16 |
| MODEL IR 1200 INSULIN PUMP (K032257) | Animas Corp. | 2003-10-16 |
| ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK (K031012) | 3M Company | 2003-10-16 |
| ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109 (K033099) | Applied Diabetes Research, Incorporated | 2003-10-16 |
| PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW (K032792) | Shanghai Jiawang Industrial Co. , Ltd. | 2003-10-15 |
| RUBBERCARE POWDERED LATEX EXAMINATION GLOVES (K032201) | Perusahaan Pelindung Getah (M) Sdn Bhd | 2003-10-10 |
| POWDER FREE VINYL EXAMINATION GLOVE (K032071) | Shanghai Foremost Plastic Industrial Co., Ltd. | 2003-10-10 |
| UNOMEDICAL MONICA INFUSION SET (K032854) | Unomedical A/S | 2003-10-09 |
| REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 (K032789) | American I.V. Products, Inc. | 2003-10-09 |
| BETEC RETRACTABLE SAFETY SYRINGE (5ML) (K031909) | Betec Medical Science Co., Ltd. | 2003-10-07 |
| BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW (K032323) | Long First (Xiamen) Plastics Co., Ltd. | 2003-10-07 |
| 3M LIQUID BANDAGE, MODEL 120-LB (K031263) | 3M Company | 2003-10-07 |
| MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS (K033039) | Mckinley, Inc. | 2003-10-07 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES (K032668) | Kingswell International, Inc. | 2003-10-06 |