| INTRAVASCULAR ADMINISTRATION SET (K003854) | Infusion Devices, Inc. | 2001-02-05 |
| SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS (K001965) | North American Medical Products, Inc. | 2001-02-02 |
| BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (K003461) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-02-01 |
| POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS) (K003737) | Perusahaan Getah Asas Sdn. Bhd. | 2001-02-01 |
| LIQUIDERM LIQUID ADHESIVE BANDAGE (K002338) | Closure Medical Corp. | 2001-01-29 |
| GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE) (K010078) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-01-29 |
| POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K003934) | Seltom Pacific Sdn. Bhd. | 2001-01-26 |
| FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A (K002719) | Tillotson Healthcare Corp. | 2001-01-26 |
| STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) (K003653) | Wrp Asia Pacific Sdn. Bhd. | 2001-01-26 |
| MEDCOMP Z-CATH (K003682) | Medical Components, Inc. | 2001-01-26 |
| GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K010054) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-01-26 |
| MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K003055) | Medline Industries, Inc. | 2001-01-26 |
| POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE (K010072) | Wrp Asia Pacific Sdn. Bhd. | 2001-01-26 |
| TIANXIE (K003748) | Suzhou Tianyi Acupuncture Instruments Co., Ltd. | 2001-01-26 |
| BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR (K991618) | Propper Mfg. Co., Inc. | 2001-01-24 |
| DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS- (K010034) | Cook, Inc. | 2001-01-24 |
| NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE (K010038) | Cambridge Marketing, Inc. | 2001-01-24 |
| POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES (K003904) | Purna Bina Sdn Bhd | 2001-01-24 |
| KENDALL-LTP TURNER SAVE-A-LINE (K003511) | The Ludlow Company LP | 2001-01-24 |
| MEDLINE STERILIZATION WRAP (K002968) | Medline Industries, Inc. | 2001-01-23 |
| GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K003872) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-01-23 |
| GEON DIGITAL CLINICAL THERMOMETER (K003223) | Geon Corp. | 2001-01-12 |
| E.N.S.I. RETRACTABLE SAFETY SYRINGE (K003348) | Ensi-Med International Pty. , Ltd. | 2001-01-12 |
| GUARDED NEEDLE 2000 (K003406) | International Medical Device Partners, Inc. | 2001-01-12 |
| MPS ACACIA PAIN KIT (K003476) | Mps Acacia | 2001-01-12 |
| FILAC FAS TEMP ELECTRONIC THERMOMETER (K003313) | The Kendall Company | 2001-01-11 |
| TAXOL ADMINISTRATION SET (K003513) | Icu Medical, Inc. | 2001-01-11 |
| PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES (K002381) | Pentaferte, S.R.L. | 2001-01-11 |
| SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES (K003675) | Shanghai China Star Corp | 2001-01-09 |
| PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION (K003827) | Bio-Plexus, Inc. | 2001-01-08 |
| STERILE PISTON SYRINGE (K002717) | Abbott Laboratories | 2001-01-08 |
| CASTLE MODEL 233HC STEAM STERILIZER (K003441) | Getinge/Castle, Inc. | 2001-01-02 |
| POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE (K003563) | Ning BO Yujiang Rubber & Plastic Co. | 2001-01-02 |
| SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20 (K992424) | Plastimed Laboratoire Pharmaceutique | 2000-12-29 |
| INJECTRITE-C15 AND INJECTRITE-C30 (K002127) | Sterling Medivations, Inc. | 2000-12-29 |
| AVITA TSO/TS1 INFRARED EAR THERMOMETER (K002182) | Avita Corporation | 2000-12-29 |
| BIOTEQ I.V. (INTRAVENOUS) SET (K002449) | Bioteque Corp. | 2000-12-22 |
| VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET (K000714) | Med-Pro Technologies, Inc. | 2000-12-21 |
| NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) (K003547) | Terang Nusa Sdn Bhd | 2000-12-21 |
| NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE (K003545) | Terang Nusa Sdn Bhd | 2000-12-21 |
| CHEMO-AIDE DISPENSING PIN (K003730) | Baxter Healthcare Corp | 2000-12-20 |
| RDH BANDAGE (K002550) | Marine Polymer Technologies, Inc. | 2000-12-20 |
| PLACEMENT-PLUS (K003642) | Catheter Innovations, Inc. | 2000-12-20 |
| GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC (K003195) | Greer Laboratories, Inc. | 2000-12-13 |
| SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103) (K003283) | Sterling Medivations, Inc. | 2000-12-13 |
| PAIN CARE MULTI-PORT CATHETER, MODEL 2000L (K003611) | Breg, Inc. | 2000-12-13 |
| ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S (K001233) | R-Group Intl. | 2000-12-13 |
| CALEO (K003067) | Drager Medizintechnik GmbH | 2000-12-13 |
| COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP (K003616) | Baxter Healthcare Corp | 2000-12-12 |
| SHENLING ACUPUNCTURE NEEDLES (K002411) | Shenling Medical Device Co., Ltd. | 2000-12-12 |
| GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES (K002569) | Malgam Ent., Inc. | 2000-12-12 |
| NOVOFINE 31 DISPOSABLE NEEDLE (K002403) | Novo Norodisk Pharmaceuticals, Inc. | 2000-12-08 |
| STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123 (K003002) | Steritec Products, Inc. | 2000-12-08 |
| FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 (K003582) | Fluidsense Corp. | 2000-12-05 |
| INFUSOMAT P (K003029) | B.Braun Medical, Inc. | 2000-12-04 |
| HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML (K003245) | Baxter Healthcare Corp | 2000-12-04 |
| NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS) (K002391) | Siam Sempermed Corp., Ltd. | 2000-12-04 |
| MEDCOMP BIO-CATH CATHETER LINE (K003110) | Medcomp | 2000-12-01 |
| B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (K002938) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000-11-29 |
| NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE (K002819) | Siam Sempermed Corp., Ltd. | 2000-11-29 |
| ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50 MICROGRAMS OR LESS (K003213) | Concept Rubber Products Sdn Bhd | 2000-11-29 |
| NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE (K002818) | Siam Sempermed Corp., Ltd. | 2000-11-29 |
| EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124 (K002861) | Steritec Products, Inc. | 2000-11-29 |
| COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL (K002064) | Wrp Asia Pacific Sdn. Bhd. | 2000-11-28 |
| COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K001613) | Wrp Asia Pacific Sdn. Bhd. | 2000-11-22 |
| MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA (K003353) | Medline Industries, Inc. | 2000-11-22 |
| VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW (K003197) | Kaohsiung Brothers Products Corp. | 2000-11-22 |
| DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL W (K003307) | Wrp Specialty Products Sdn. Bhd. | 2000-11-22 |
| DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE (K003309) | Wrp Specialty Products Sdn. Bhd. | 2000-11-22 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR (K003321) | Shanghai Antares Industries, Inc. | 2000-11-22 |
| DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA (K003132) | Wrp Specialty Products Sdn. Bhd. | 2000-11-17 |
| DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A (K002692) | Hmi Industries, Inc. | 2000-11-17 |
| BIOSENSORS CENTRAL VENOUS CATHETER KITS (K002786) | Sunscope Intl., Inc. | 2000-11-17 |
| RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER (K003335) | Hill-Rom Air-Shields | 2000-11-17 |
| MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1 (K003308) | Microlife Corp. | 2000-11-14 |
| FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO (K002720) | Tillotson Healthcare Corp. | 2000-11-09 |
| MULTIPLE-VINYL EXAM GLOVE, POWDERED (K003133) | Excellence Ent. Co., Ltd. | 2000-11-07 |
| DUPLOGRIP (K003193) | Baxter Healthcare Corp | 2000-11-07 |
| MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (K003087) | Sporicidin Intl. | 2000-11-07 |
| RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE (K003233) | Riverstone Resources Sdn Bhd | 2000-11-03 |
| TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION (K003006) | Arrow Intl., Inc. | 2000-10-27 |
| RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) (K003232) | Riverstone Resources Sdn Bhd | 2000-10-26 |
| STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (K994321) | Automatic Liquid Packaging, Inc. | 2000-10-25 |
| MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW (K003091) | Medline Industries, Inc. | 2000-10-24 |
| DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL (K002975) | Wrp Specialty Products Sdn. Bhd. | 2000-10-24 |
| SIMPLICITY SOFT INFUSION SET (K002492) | Sterling Medivations, Inc. | 2000-10-24 |
| DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K000838) | P.T. Healthcare Glovindo | 2000-10-23 |
| DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K002814) | Shanghai PM Plastics Enterise Co., Ltd. | 2000-10-20 |
| BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE) (K994276) | Biopro (M) Sdn Bhd | 2000-10-20 |
| BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE) (K994281) | Biopro (M) Sdn Bhd | 2000-10-20 |
| THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD (K001795) | Avitro, LLC | 2000-10-19 |
| SPIRIT ACUPUNCTURE NEEDLE (K003010) | United Pacific Co., Ltd. | 2000-10-19 |
| SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE (K003225) | Baxter Healthcare Corp | 2000-10-19 |
| 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE (K000632) | Avitro, LLC | 2000-10-19 |
| JETCAN HUBER NEEEDLE SET (K002471) | Pfm Produkte Fur Die Medizin AG | 2000-10-19 |
| SUREONE INSULIN SYRINGE (K002921) | Hosuk Co., Ltd. | 2000-10-18 |
| OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS) (K002922) | Omnigrace (Thailand) , Ltd. | 2000-10-16 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K002870) | Shanghai PT Plastics Enterprise Company, Ltd. | 2000-10-16 |
| SIMPLICITY DISPOSABLE PEN NEEDLE (K002180) | Sterling Medivations, Inc. | 2000-10-13 |
| PACIFIER THERMOMETER MODELS VT-901F, VT901C (K002562) | Valeo Corp. | 2000-10-13 |