| DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (K991608) | Dermaphylyx, Inc. | 1999-07-20 |
| TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE (K992122) | Maxxim Medical | 1999-07-15 |
| DYNAREX DRAIN SPONGE (K991694) | Dynarex Corp. | 1999-07-15 |
| DYNAREX NON-WOVEN SPONGE (K991695) | Dynarex Corp. | 1999-07-15 |
| PRO-PORTION CLEANER/DISINFECTANT (K991509) | Sultan Chemists, Inc. | 1999-07-14 |
| CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K991616) | Hartalega Sdn Bhd | 1999-07-14 |
| LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN) (K992031) | Shanghai Changzheng Latex Factory | 1999-07-12 |
| PASS/FAIL CHALLENGE PACK (K991276) | Propper Mfg. Co., Inc. | 1999-07-12 |
| POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES (K991624) | Smart Glove Corp. Sdn Bhd | 1999-07-09 |
| TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE (K990761) | Tuttnauer U.S.A Co, Ltd. | 1999-07-09 |
| GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K991554) | Glovco (M) Sdn. Bhd. | 1999-07-09 |
| MTI 1 ML SYRINGE (K991225) | Micro Therapeutics, Inc. | 1999-07-08 |
| NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC (K991849) | Seal Polymer Industries Bhd. | 1999-07-07 |
| NITRILE EXAMINATION GLOVE, POWDERED, BLUE (K991821) | Ning BO Yujiang Rubber & Plastic Co. | 1999-07-01 |
| ANESFLOW-DUAL DRIP IV INFUSION SET (K990496) | Innovative Design Assoc. | 1999-07-01 |
| WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS (K991275) | Mckinley, Inc. | 1999-07-01 |
| DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE (K991457) | Shanghai Palomar Mountain Industries, Inc. | 1999-07-01 |
| MCKINLEY SP DISPOSABLE INFUSION PUMP (K990461) | Mckinley, Inc. | 1999-06-30 |
| MAERSK MEDICAL CONTOUR INFUSION SET (K991759) | Maersk Medical A/S | 1999-06-25 |
| TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC (K990020) | Te ME NA S.A.R.L. | 1999-06-24 |
| INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM (K991653) | Rymed Technologies, Inc. | 1999-06-24 |
| HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C (K984116) | Abatement Technologies, Inc. | 1999-06-24 |
| LATEX EXAMINATION GLOVES (PRE POWDERED) (K991690) | Usg Healthguard Sdn Bhd | 1999-06-24 |
| LATEX EXAMINATION GLOVES (POWDER FREE) (K991689) | Usg Healthguard Sdn Bhd | 1999-06-24 |
| BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED) (K990876) | Brightway Holdings Sdn. Bhd. | 1999-06-23 |
| LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE (K991749) | La Glove (M) Sdn. Bhd. | 1999-06-23 |
| HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K991304) | M.R.G. Industries Sdn. Bhd. | 1999-06-23 |
| ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O (K991743) | Shield Gloves Manufacturer (M) Sdn Bhd | 1999-06-23 |
| ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR (K991746) | Shield Gloves Manufacturer (M) Sdn Bhd | 1999-06-23 |
| ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM (K991745) | Shield Gloves Manufacturer (M) Sdn Bhd | 1999-06-23 |
| BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN (K991750) | Brightsway Holdings Sdn Bhd | 1999-06-23 |
| BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE (K991752) | Brightsway Holdings Sdn Bhd | 1999-06-23 |
| LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESSOF WATER EXTRACTABLE PROTEIN PER G (K991748) | La Glove (M) Sdn. Bhd. | 1999-06-23 |
| MINIMED 407C INFUSION PUMP, MODEL 407C (K991013) | Medtronic Minimed | 1999-06-23 |
| SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT (K991744) | Shield Gloves Manufacturer (M) Sdn Bhd | 1999-06-23 |
| HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES (K991305) | M.R.G. Industries Sdn. Bhd. | 1999-06-21 |
| NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O (K991742) | Yty Industry (Manjung) Sdn Bhd | 1999-06-21 |
| POWDER FREE VINYL EXAMINATION GLOVES (K983856) | Shijiazhuang Brethern Plastic Co., Ltd. | 1999-06-21 |
| SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES (K990186) | Shanghai Intco. Plastic & Rubber Products Co., Ltd. | 1999-06-21 |
| POWDERED VINYL EXAMINATION GLOVE (K983893) | Shijiazhuang Brethern Plastic Co., Ltd. | 1999-06-21 |
| HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO (K991513) | I-Flow Corp. | 1999-06-21 |
| CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (K991155) | C.V. Anlis Abadi International | 1999-06-21 |
| MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTA\ (K991153) | Medtexx Industries (Thai) Co. , Ltd. | 1999-06-21 |
| TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER (K991406) | Terumo Medical Corp. | 1999-06-16 |
| CADD ADMINISTRATION SET (K991599) | Sims Deltec, Inc. | 1999-06-15 |
| MODIFICATION OF: STERRAD BI TEST PACK (K991675) | Advanced Sterilization Products | 1999-06-15 |
| DAHEDI INSULIN INFUSION PUMP (K991376) | Disetronic Medical Systems | 1999-06-15 |
| MONOJECT INSULIN SYRINGE (K991758) | The Kendal Co. | 1999-06-14 |
| K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K (K984576) | Terumo Europe N.V. | 1999-06-14 |
| LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) (K991686) | Arista Latindo Industrial Ltd. P.T | 1999-06-11 |
| STERI-PAK LF BOWIE-DICK TEST PACK (K990246) | Steritec Products Mfg Co, Inc. | 1999-06-10 |
| BROWNE MVI ETHYLENE OXIDE INDICATOR (K991418) | Albert Browne , Ltd. | 1999-06-10 |
| CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 (K991301) | Sims Deltec, Inc. | 1999-06-09 |
| CADD-TPN ADMINISTRATION SET, MODEL 21-7071 (K991255) | Sims Deltec, Inc. | 1999-06-09 |
| MINIMED 508 INSULIN PUMP (K990801) | Medtronic Minimed | 1999-06-08 |
| SOFTINJECT (K991680) | Androsystems Srl | 1999-06-03 |
| AUTODOSE INFUSION SYSTEM (K990889) | Tandem Medical, Inc. | 1999-06-03 |
| POWDER FREE BLUE NITRILE GLOVE (K990668) | Tg Medical Sdn. Bhd. | 1999-06-03 |
| POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED) (K991511) | Perusahaan Getah Asas Sdn. Bhd. | 1999-06-03 |
| A P HARNESS (K981860) | Paraworks Enterprise, Ltd. | 1999-06-03 |
| QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED (K991462) | Latexx Partners Bhd. | 1999-05-28 |
| LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL, SMALL,MEDIUM,LARGE,EXTRA LARGE (K991158) | P. T. Tata Rubberindo Industries | 1999-05-28 |
| STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G (K991612) | Sterilogic Waste Systems, Inc. | 1999-05-28 |
| HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES (K991640) | M.R.G. Industries Berhad | 1999-05-28 |
| SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE (K990488) | Terang Nusa Sdn Bhd | 1999-05-28 |
| NORMAL SALINE FLUSH SYRINGE (K984614) | Rocap Div. of Sabratek Corp. | 1999-05-27 |
| TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 (K984497) | Oriental System Technology, Inc. | 1999-05-26 |
| SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES (K991415) | Supermax Sdn Bhd | 1999-05-26 |
| BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (K991493) | Masju Sdn. Bhd. | 1999-05-26 |
| RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) (K990963) | Riverstone Resources Sdn Bhd | 1999-05-26 |
| BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) (K990878) | Brightway Holdings Sdn. Bhd. | 1999-05-21 |
| LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE) (K990882) | La Glove (M) Sdn. Bhd. | 1999-05-21 |
| EASYSAFE RETRACTING NEEDLE SYRINGE (K991039) | Saf-T-Med, Inc. | 1999-05-21 |
| POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES (K990690) | Top Glove Sdn. Bhd. | 1999-05-20 |
| VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000 (K984270) | Roger L. Goodman, D.D.S., P.C. | 1999-05-20 |
| MODIFICATION OF:BIODERM FOAM WOUND DRESSING (K990955) | Bioderm, Inc. | 1999-05-18 |
| THE VAULT (K990936) | Stik Stoppers, Inc. | 1999-05-18 |
| PRE POWDERED LATEX EXAMINATION GLOVES (K990879) | Apl Products Sdn. Bhd. | 1999-05-17 |
| NUGARD NITRIL NITRILE EXAMINATION GLOVE (K990841) | Terang Nusa Sdn Bhd | 1999-05-17 |
| LATEX EXAMINATION GLOVES (POWDERED) (K984229) | Sama Kejuruteraan Sdn.Bhd. | 1999-05-17 |
| WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 (K991627) | Respironics, Inc. | 1999-05-17 |
| NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE (K990840) | Terang Nusa Sdn Bhd | 1999-05-17 |
| PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) (K991404) | Itl Corporation Pty, Ltd. | 1999-05-14 |
| FLEXNEEDLE PLUS (K990693) | Act Medical, Inc. | 1999-05-14 |
| OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE (K990698) | Omnigrace (Thailand) , Ltd. | 1999-05-13 |
| OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE (K990696) | Omnigrace (Thailand) , Ltd. | 1999-05-13 |
| FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES (K990729) | Acc Intl. | 1999-05-13 |
| ACCLAIM INFUSION PUMP (K991501) | Abbott Laboratories | 1999-05-13 |
| 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU (K991363) | Sorenson Medical, Inc. | 1999-05-13 |
| 1000 PRESSURE INFUSION SIGMACON 1000 (K990447) | Valley West, Inc. | 1999-05-12 |
| OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE (K990701) | Omnigrace (Thailand) , Ltd. | 1999-05-05 |
| ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER (K984189) | Maxxim Medical | 1999-05-05 |
| BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES (K991085) | Long First (Xiamen) Co., Ltd. | 1999-05-05 |
| ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN (K984496) | Atrium Medical Corp. | 1999-05-05 |
| LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN (K991043) | Glovco (M) Sdn. Bhd. | 1999-05-04 |
| TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES (K990577) | Ta Chia Rubber Ind. Corp. | 1999-05-04 |
| POWDER FREE LATEX EXAMINATION GLOVES (K990686) | Tower Rubber Industries Sdn. Bhd. | 1999-05-04 |
| OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE (K990695) | Omnigrace (Thailand) , Ltd. | 1999-05-04 |
| DBC, DONG BANG ACUPUNCTURE NEEDLES (K990328) | Morning Star, Dong Bang Acupuncture U.S.A., Inc. | 1999-05-04 |
| BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES (K990946) | Long First (Xiamen) Co., Ltd. | 1999-05-04 |