| SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1 (K001853) | Medtech Systems, Inc. | 2001-08-22 |
| TEMP 3 (K012276) | Medical Solutions, Inc. | 2001-08-20 |
| SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE (K011765) | Sunmax Enterprise Shanghai Co. , Ltd. | 2001-08-16 |
| POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE (K012048) | Wrp Asia Pacific Sdn. Bhd. | 2001-08-16 |
| SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES (K011717) | Sunmax Enterprise Shanghai Co. , Ltd. | 2001-08-14 |
| HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 (K011928) | Northgate Technologies, Inc. | 2001-08-10 |
| SIMPLICITY EURO QD INFUSION SET (K012330) | Sterling Medivations, Inc. | 2001-08-10 |
| REUSABLE GLASS SYRINGES (K011176) | Lockett Medical Corp. | 2001-08-10 |
| STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE (K012282) | Cypress Medical Products, Ltd. | 2001-08-06 |
| CROSS-CHECKS DUAL, MODEL CI 125 (K010534) | Steritec Products, Inc. | 2001-08-06 |
| EZ SYRINGE (K011951) | Owen Mumford, Ltd. | 2001-08-02 |
| M5T INSTANT FEVER THERMOMETER (K012217) | Medisim, Ltd. | 2001-08-01 |
| CENTRAL VENOUS CATHETER (K003839) | Boston Scientific Corp | 2001-08-01 |
| POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR (K011791) | Latexx Partners Bhd. | 2001-08-01 |
| NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES (K011792) | Latexx Partners Bhd. | 2001-08-01 |
| NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN) (K012166) | Best Manufacturing Company | 2001-08-01 |
| PROTECTIV ACUVANCE IV CATHETER SYSTEM (K012128) | Ethicon Endo-Surgery, Inc. | 2001-08-01 |
| POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K011995) | Quality Latex Products Malaysia Sdn Bhd | 2001-07-31 |
| OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM (K011549) | Ohmeda Medical | 2001-07-19 |
| PVC FREE INTRAVASCULAR ADMINISTRATION SET (K011216) | Biometrix , Ltd. | 2001-07-18 |
| 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (K011982) | Bd | 2001-07-17 |
| LATEX EXAMINATION GLOVES- POWDER FREE, BLUE (K011712) | Pt.Shamrock Manufacturing Corp. | 2001-07-17 |
| POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K011883) | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-17 |
| POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K011884) | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-17 |
| WUNDCATH CONDUCTION CATHETER (K003966) | Micor, Inc. | 2001-07-17 |
| SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K011885) | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-16 |
| TEMPORALSCANNER THERMOMETER, SENSORTOUCH (K011291) | Exergen Corp. | 2001-07-12 |
| PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (K000266) | Primary Care Solutions, Inc. | 2001-07-12 |
| PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (K000265) | Primary Care Solutions, Inc. | 2001-07-12 |
| HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO (K011925) | Sims Portex, Inc. | 2001-07-12 |
| VACUETTE SAFETY BLOOD COLLECTION SET (K011786) | Greiner Vacuette North America, Inc. | 2001-07-12 |
| EAR THERMOMETER, MODELS ST613C AND ST613F (K011254) | Mesure Technology | 2001-07-10 |
| ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) (K011808) | Asia-Med GmbH and CO KG | 2001-07-10 |
| POWDERED BLUE NITRILE EXAMINATION GLOVES (K011924) | Seltom Pacific Sdn. Bhd. | 2001-07-10 |
| POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES (K011293) | Multisafe Sdn. Bhd. | 2001-07-10 |
| CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE (K011497) | Tillotson Healthcare Corp. | 2001-07-10 |
| POWDER FREE LATEX EXAMINATION GLOVES (K010546) | Jb Star Sdn Bhd | 2001-07-10 |
| SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K011882) | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-10 |
| CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001 (K003254) | Mission Medicl Devices | 2001-07-09 |
| BW ACUPUNCTURE NEEDLES (K011669) | H F Intl. Co. | 2001-07-09 |
| POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH (K011895) | Pwa Industries Sdn. Bhd. | 2001-07-09 |
| MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS (K011117) | Mps Acacia | 2001-07-09 |
| TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX (K010235) | Oriental System Technology, Inc. | 2001-07-09 |
| BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) ( (K011728) | Brightway Holdings Sdn. Bhd. | 2001-07-09 |
| DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K011482) | Wrp Asia Pacific Sdn. Bhd. | 2001-07-09 |
| SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE (K011713) | Kimberly-Clark Corp. | 2001-07-05 |
| POWDERED LATEX EXAMINATION GLOVES (K011922) | Seltom Pacific Sdn. Bhd. | 2001-07-05 |
| THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM (K010692) | Spintech, Inc. | 2001-06-29 |
| MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM (K011317) | Baxter Healthcare Corp | 2001-06-28 |
| MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER (K002409) | Automatic Medical Technologies, Inc. | 2001-06-28 |
| SIDEPORT PINCH CLAMP DEVICE (K010888) | Medivice Systems, Ltd. | 2001-06-27 |
| NPAC EAR THERMOMETER MODEL TD 402 (K011704) | Norm Pacific Automation Corp. | 2001-06-27 |
| KEYST0NE MEDICAL PICC CATHETER (K011860) | Keystone Medical | 2001-06-27 |
| SEP-10S PLUS, AND SP-12S PRO. (K010937) | Viltechmeda | 2001-06-25 |
| INTER-VIAL (K010703) | Duoject Medical Systems, Inc. | 2001-06-25 |
| MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM (K011612) | Hydrocision, Inc. | 2001-06-22 |
| POWDER FREE NITRILE EXAMINATION GLOVES (K010233) | P.T. Healthcare Glovindo | 2001-06-22 |
| MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE (K011593) | Ansell Healthcare Products, Inc. | 2001-06-21 |
| NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET (K011297) | Nipro Medical Corp. | 2001-06-20 |
| JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G (K010406) | Jms Co., Ltd. | 2001-06-20 |
| JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G (K010410) | Jms Co., Ltd. | 2001-06-20 |
| INTERLINK THREADED LOCK CANNULA (K011858) | Bd | 2001-06-19 |
| SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS (K011187) | Sterling Medivations, Inc. | 2001-06-19 |
| CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN (K011231) | Protection Gloves Sdn. Bhd. | 2001-06-13 |
| YOUNG-HEALTH SUPER EAR THERMOMETER (K002727) | Young Health Ind. Co., Ltd. | 2001-06-13 |
| BD SPRING BASED SYRINGE (K011103) | Bd | 2001-06-13 |
| FAST THERMOMETER MODELS ST713C AND ST713F (K011585) | Mesure Technology | 2001-06-13 |
| CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN) (K010854) | Protection Gloves Sdn. Bhd. | 2001-06-13 |
| GERATHERM BABYWATCH TEMPERATURE MONITOR (K001281) | Geratherm AG | 2001-06-12 |
| AMBULATORY ENTERAL NUTRITION PUMP (K003047) | Ross Product Div. Abbott Laboratories | 2001-06-12 |
| PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK (K011336) | Churchill Medical Systems, Inc. | 2001-06-12 |
| NAC PLUS NEEDLELESS ACCESS CONNECTOR (K011193) | Porex Medical Products | 2001-06-12 |
| INSULIN PEN NEEDLE ADAPTER (K010887) | Ohana Needle Co. | 2001-06-08 |
| NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5 (K011377) | Sgmp Co., Ltd. | 2001-06-07 |
| PARADIGM QUICK-SET INFUSION SET (K011071) | Maersk Medical A/S | 2001-06-07 |
| HYCARE LATEX EXAMINATION GLOVE, POWDERED (K010875) | Hycare Intl. Co., Ltd. | 2001-06-07 |
| NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG (K011370) | Sgmp Co., Ltd. | 2001-06-07 |
| NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW (K011371) | Sgmp Co., Ltd. | 2001-06-07 |
| STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED (K010856) | Brightway Holdings Sdn. Bhd. | 2001-06-06 |
| TEMP-A-SURE (K010866) | Homecare Technologies , Ltd. | 2001-06-06 |
| ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 (K011442) | Abbott Laboratories | 2001-06-05 |
| POWDERED VINAL EXAM GLOVES (K011414) | Heyuan Hongli Industries, Inc. | 2001-06-05 |
| POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM (K011563) | U.O.P. Rubber Products Sdn Bhd | 2001-06-05 |
| PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT (K010824) | Science Incorporated | 2001-06-05 |
| POWDER-FREE VINYL EXAM GLOVE, YELLOW (K011413) | Heyuan Hongli Industries, Inc. | 2001-06-05 |
| SIMPLICITY SOFT QD SILVER INFUSION SET (K011580) | Sterling Medivations, Inc. | 2001-06-05 |
| STRYKER PAINPUMP PCA (K003543) | Stryker Instruments | 2001-06-05 |
| JET SYRINGE MODEL-100500 (K003741) | Equidyne Systems, Inc. | 2001-06-01 |
| SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP (K011587) | Entracon Corp. | 2001-06-01 |
| POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K011474) | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-05-31 |
| X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K010961) | Ansell Healthcare Products, Inc. | 2001-05-31 |
| AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY (K010865) | STERIS Corporation | 2001-05-31 |
| POWDER-FREE VINYL EXAM GLOVES (K011412) | Heyuan Hongli Industries, Inc. | 2001-05-31 |
| MEDISYSTEMS LUER ACCESS INJECTION SITE (K010279) | Medisystems Corp. | 2001-05-29 |
| ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) (K011369) | Safety Syringes, Inc. | 2001-05-29 |
| SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K010947) | Beijing Reagent Latex Products Co., Ltd. | 2001-05-25 |
| EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200 (K011376) | Yty Industry (Manjung) Sdn Bhd | 2001-05-25 |
| POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES (K011186) | Allegiance Healthcare Corp. | 2001-05-25 |
| INFANT LIMB HOLDER, MODELS 306080 & 306081 (K010818) | Skil-Care Corp. | 2001-05-24 |
| NEEDLELOK HYPODERMIC NEEDLE PROTECTION (K011004) | Diasol, Inc. | 2001-05-24 |