| VACUCATH I.V. CATHETER INTRODUCTER (K003187) | Auto/Cath Vascular Access, Inc. | 2001-05-21 |
| FISTULOK FISTULA NEEDLE PROTECTION (K010958) | Diasol, Inc. | 2001-05-18 |
| CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 (K010644) | Skil-Care Corp. | 2001-05-18 |
| SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL (K011198) | Maxxim Medical, Inc. | 2001-05-17 |
| POWDER-FREE NITRILE EXAM GLOVE, BLUE (K011286) | Ningbo Yujiang Plastic & Rubber Co. , Ltd. | 2001-05-16 |
| UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K010881) | N.S. Uni-Gloves Sdn. Bhd. | 2001-05-16 |
| COLLEAGUE VOLUMETRIC INFUSION PUMP (K010566) | Baxter Healthcare Corp | 2001-05-15 |
| EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET (K010197) | Exelint International, Co. | 2001-05-14 |
| SKINGARD POLYCOAT GLOVE (K004018) | Top Quality Mfg., Inc. | 2001-05-11 |
| POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR (K010803) | Hwa Teh Industrial Sdn. Bhd. | 2001-05-11 |
| UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K010879) | N.S. Uni-Gloves Sdn. Bhd. | 2001-05-10 |
| POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED (K011271) | Perusahaan Getah Asas Sdn. Bhd. | 2001-05-08 |
| MEDLINE STERISET STERILIZATION CONTAINER (K010825) | Medline | 2001-05-08 |
| GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES (K011120) | Nipro Diabetes Systems, Inc. | 2001-05-08 |
| POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0 (K010483) | Pt. Medisafe Technologies | 2001-05-03 |
| LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER) (K010863) | La Glove (M) Sdn. Bhd. | 2001-05-03 |
| WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION (K003402) | Welcon, Inc. | 2001-05-01 |
| ABBOTT ACCLAIM ENCORE, MODEL 12237 (K011096) | Abbott Laboratories | 2001-05-01 |
| ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB (K002718) | Tillotson Healthcare Corp. | 2001-05-01 |
| POWDER FREE NITRILE EXAMINATION GLOVE (K011012) | Contract Latex Dippers Sdn Bhd | 2001-05-01 |
| APPLICATOR TIP/DUAL SPRAYER KIT (K010708) | Interpore Cross Intl. | 2001-04-30 |
| VACUETTE SPEEDY QUICK-RELEASE HOLDER (K003812) | Greiner Vacuette North America, Inc. | 2001-04-30 |
| SIMPLICITY WING INFUSION SET (K010886) | Sterling Medivations, Inc. | 2001-04-30 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K010627) | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-04-24 |
| POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K010626) | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-04-23 |
| SHIELDING NEEDLE HOLDER (K003381) | U.S. Safety Syringes Co., Inc. | 2001-04-23 |
| POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K010628) | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-04-23 |
| SAFESTING AND SAFESTING HUB (K011003) | Diasol, Inc. | 2001-04-20 |
| SIMPLICITY SOFT QD EASY INFUSION SET (K010788) | Sterling Medivations, Inc. | 2001-04-20 |
| DISPO-MED 7.6 LITER SHARPS CONTAINER (K003521) | Master Benefits, Inc. | 2001-04-19 |
| BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM) (K010890) | Becton, Dickinson and Co. | 2001-04-19 |
| TEMP SCAN (K010383) | Tenghi Co., Ltd. | 2001-04-18 |
| SIMPLICITY WINGED QD INFUSION SET (K010676) | Sterling Medivations, Inc. | 2001-04-18 |
| SIMPLICITY INFUSER INFUSION SET (K010647) | Sterling Medivations, Inc. | 2001-04-13 |
| UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET (K000592) | Myco Medical Supplies, Inc. | 2001-04-12 |
| SIMPLICITY SILVER SET SOFT INFUSION (K010846) | Sterling Medivations, Inc. | 2001-04-12 |
| AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) (K010462) | Avita Corporation | 2001-04-11 |
| FUNET AMY MAMA BODY THERMOMETER (K003326) | Funai Radio & Communications Corp. | 2001-04-11 |
| LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES (K010767) | Horizon Medical Products, Inc. | 2001-04-10 |
| POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES (K010486) | Pt. Medisafe Technologies | 2001-04-10 |
| POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR (K010719) | Perusahaan Getah Asas Sdn. Bhd. | 2001-04-10 |
| POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE (K010671) | Tong Ruhn Medical Products Co., Ltd. | 2001-04-09 |
| POWDER FREE TEXTURED VINYL EXAMINATION GLOVES (K010830) | General Gloves Corp. | 2001-04-09 |
| MODIFICATION TO PLUM XL INFUSION PUMP (K010924) | Abbott Laboratories | 2001-04-06 |
| POWDER FREE ELASTIC VINYL EXAMINATION GLOVES (K010829) | General Gloves Corp. | 2001-04-05 |
| HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE) (K003350) | Pamitex Industries Sdn Bhd | 2001-04-05 |
| RECONSTITUTION KIT & VIAL CONNECTOR (K010623) | Bioject, Inc. | 2001-04-05 |
| MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 (K010377) | Minimed, Inc. | 2001-04-05 |
| POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE (K010110) | Shen Wei (Usa), Inc. | 2001-04-03 |
| LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE) (K010861) | La Glove (M) Sdn. Bhd. | 2001-04-03 |
| LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE) (K010860) | La Glove (M) Sdn. Bhd. | 2001-04-03 |
| PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E (K010538) | Rd Medical Mfg., Inc. | 2001-03-30 |
| POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K010097) | Shen Wei (Usa), Inc. | 2001-03-30 |
| SARSTEDT NEEDLE PROTECTOR (K003382) | Sarstedt, Inc. | 2001-03-30 |
| POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE (K010663) | Tong Ruhn Medical Products Co., Ltd. | 2001-03-30 |
| PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR (K994381) | Raven Biological Laboratories, Inc. | 2001-03-30 |
| DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A (K010616) | Hmi Industries, Inc. | 2001-03-28 |
| EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 (K002705) | Baxa Corp. | 2001-03-28 |
| LATEX EXAMINATION GLOVES-POWDER FREE (K010356) | Enzymic Technologies Sdn Bhd | 2001-03-27 |
| LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE (K010347) | Enzymic Technologies Sdn Bhd | 2001-03-27 |
| 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (K003553) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-03-21 |
| OHMEDA MEDICAL GIRAFFE INCUBATOR (K010222) | Ohmeda Medical | 2001-03-21 |
| NPAC MULTI-USE THERMOMETER, MODEL TD400 (K010224) | Norm Pacific Automation Corp. | 2001-03-18 |
| 4 PORT, 4 WAY STOPCOCK (K010217) | George Loo, MD | 2001-03-18 |
| SURSHIELD WINGED INFUSION SET (K010103) | Terumo Medical Corp. | 2001-03-15 |
| INNOVO (K010359) | Novo Nordisk A/S | 2001-03-14 |
| SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103) (K010373) | Sterling Medivations, Inc. | 2001-03-13 |
| CENTURA PHOTOTHERAPY SPOTLIGHT (K010495) | Medical Illumination International, Inc. | 2001-03-09 |
| SEROJET (K003908) | Bioject, Inc. | 2001-03-08 |
| PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER (K010426) | Sims Deltec, Inc. | 2001-03-08 |
| SWABSITE SWABBABLE VALVE, MODEL 245000 (K002689) | Quest Medical, Inc. | 2001-03-06 |
| INJEX 50 SYSTEM (K003864) | Equidyne Systems, Inc. | 2001-03-06 |
| BD ECLIPSE HYPODERMIC NEEDLE (K010188) | Bd Medical Systems | 2001-03-01 |
| DUAL LUMEN MIDLINE CATHETER (K010349) | Catheter Innovations, Inc. | 2001-02-28 |
| HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES (K010077) | Pwa Industries Sdn. Bhd. | 2001-02-28 |
| MAC ACUPUNCTURE NEEDLE (K002827) | Haenglim Seowon Corp. | 2001-02-28 |
| MODEL THERMO TEK QUICKCARE (K010502) | Saat , Ltd. | 2001-02-27 |
| MAEDA NEW NEEDLE DISPOSABLE (K000581) | Maeda Toyokichi Shoten | 2001-02-23 |
| MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S (K010021) | Medical Components, Inc. | 2001-02-23 |
| EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 (K003470) | Tuttnauer Co. , Ltd. | 2001-02-20 |
| SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) (K010297) | Maxxim Medical | 2001-02-16 |
| STERILE NITRILE POWDER-FREE EXAMINATION GLOVES (K010211) | Allegiance Healthcare Corp. | 2001-02-15 |
| ACCUFUSER; ACCUFUSER PLUS (K003915) | Help Technologies | 2001-02-15 |
| DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET (K003977) | Disetronic Medical Systems AG | 2001-02-15 |
| NITRILE EXAMINATION GLOVES (POWERED) (K003922) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-02-15 |
| INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET (K001329) | Lifemed of California | 2001-02-14 |
| SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE (K003571) | Terumo Medical Corp. | 2001-02-12 |
| VORTEX ACCESS SYSTEM (K010189) | Horizon Medical Products, Inc. | 2001-02-12 |
| TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP (K993856) | Tuttnauer U.S.A Co, Ltd. | 2001-02-09 |
| POWDERFREE NITRILE PATIENT EXMINATION GLOVE (K003985) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-02-09 |
| JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE (K010231) | Jk Gloves Sdn. Bhd. | 2001-02-09 |
| NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR (K010095) | Sgmp Co., Ltd. | 2001-02-09 |
| EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET (K003627) | Exelint International, Co. | 2001-02-08 |
| THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F (K002712) | Saat , Ltd. | 2001-02-08 |
| HOLY DRAGON ACUPUNCTURE NEEDLES (K002910) | Anc Import & Export Co. , Ltd. | 2001-02-07 |
| CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L (K003533) | Steritec Products, Inc. | 2001-02-07 |
| ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ (K010238) | Actherm, Inc. | 2001-02-06 |
| SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K004048) | Tillotson Healthcare Corp. | 2001-02-06 |
| SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES (K010247) | Shanghai China Star Corp | 2001-02-06 |
| TAI-CHI ACUPUNCTURE NEEDLES (K003760) | Lhasa Medical, Inc. | 2001-02-06 |