| MICROJET QUARK, MODEL U100 OR U40 (K013807) | Cane S.R.L. | 2001-12-12 |
| SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP (K013767) | Sterling Medivations, Inc. | 2001-12-12 |
| H.M.T. ACUPUNCTURE NEEDLE (K012501) | Hummingbird Medical Technology, LLC | 2001-12-11 |
| ACUGLIDE BRAND ACUPUNCTURE NEEDLES (K012583) | Helio Medical Supplies, Inc. | 2001-12-11 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K013753) | Canopus Medical Supply Co., Ltd. | 2001-12-10 |
| Z-NET (K001003) | Demite Limited | 2001-12-10 |
| BI-3M NEEDLE-FREE INJECTOR SYSTEM (K013256) | Felton International, Inc. | 2001-12-07 |
| METAPAK MULTI-PURPOSE INSTRUMENT TRAY (K993535) | Riley Medical, Inc. | 2001-12-07 |
| LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM (K013333) | Innovative Gloves Co;, Ltd. | 2001-12-07 |
| ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K013537) | Koon Seng Sdn Bhd | 2001-12-07 |
| COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE (K013244) | Med Gen, Inc. | 2001-12-07 |
| NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E (K013288) | Sgmp Co., Ltd. | 2001-12-03 |
| PAIN CARE 3200 (K013928) | Breg, Inc. | 2001-12-03 |
| SIMPLICITY CLASSIC WING QD INFUSION SET (K013502) | Sterling Medivations, Inc. | 2001-12-03 |
| NIPRO SAFELET CATH (K013287) | Nipro Medical Corp. | 2001-12-03 |
| POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 (K013443) | Maxter Glove Manufacturing Sdn Bhd | 2001-11-29 |
| MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE (K013261) | Shanghai Motex Healthcare Co., Ltd. | 2001-11-29 |
| DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE (K013782) | Disetronic Medical Systems | 2001-11-20 |
| INFUSION IV SET (K001879) | Nirvi Intl. USA | 2001-11-20 |
| COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES (K013239) | Med Gen, Inc. | 2001-11-20 |
| SMART GLOVE STERILE NITRILE EXAM GLOVE (K012853) | Smart Glove Corp. Sdn Bhd | 2001-11-16 |
| STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G (K012856) | Smart Glove Corp. Sdn Bhd | 2001-11-16 |
| AUTOJECT 2 (K013362) | Owen Mumford USA, Inc. | 2001-11-13 |
| SINGLE DOSE DISPENSING PIN, MODEL 2201 (K013087) | Alaris Medical Systems, Inc. | 2001-11-13 |
| SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE (K012815) | Kimberly-Clark Corp. | 2001-11-13 |
| INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS (K013073) | Becton Dickinson Infusion Therapy Systems, Inc. | 2001-11-08 |
| 3CC NMT SAFETY SYRINGE (K010819) | New Medical Technology , Ltd. | 2001-11-08 |
| LIFTLOC SAFETY INFUSION SET (K013394) | Specialized Health Products, Inc. | 2001-11-08 |
| SURESET INFUSION SET, MODEL 8023 (K012429) | Applied Diabetes Research, Incorporated | 2001-11-06 |
| TST CONTROL INTEGRATOR FOR STEAM STERILIZERS (K002937) | Albert Browne , Ltd. | 2001-11-05 |
| ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR (K012714) | Koon Seng Sdn Bhd | 2001-10-31 |
| MICROMEDICS FIBRIJET AEROSOL APPLICATOR (K012868) | Micromedics, Inc. | 2001-10-29 |
| CW DISPOSABLE ACUPUNCTURE NEEDLE (K011248) | Acusupply, Inc. | 2001-10-29 |
| MONOJECT SAFETY NEEDLE (K012736) | Tyco Healthcare | 2001-10-25 |
| COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 (K012832) | Nxstage Medical, Inc. | 2001-10-24 |
| SECUREGUARD RETRACTABLE SAFETY SYRINGE (K012121) | Safegard Medical Products, Inc. | 2001-10-24 |
| TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE (K013016) | Tillotson Healthcare Corp. | 2001-10-19 |
| PROSAFE SAFETY SYRINGE (K012726) | Hou-Se Medical, Inc. | 2001-10-18 |
| HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE (K011247) | Acusupply, Inc. | 2001-10-17 |
| ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES (K012499) | Shanghai Antares Industries, Inc. | 2001-10-16 |
| ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW (K012339) | Shanghai Antares Industries, Inc. | 2001-10-16 |
| MT ALERT INFUSION MONITOR (K013121) | Sierra Biosearch, Inc. | 2001-10-15 |
| FAS ENDOLUMINAL BRUSH (K012641) | Fas Medical , Ltd. | 2001-10-15 |
| MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE (K011283) | The Kendall Company | 2001-10-15 |
| SURSHIELD SAFETY WINGED BLOOD COLLECTION SET (K013164) | Terumo Medical Corp. | 2001-10-15 |
| POWDERED LATEX EXAMINATION GLOVES (K013026) | Great Glove (Thailand) Co. , Ltd. | 2001-10-15 |
| CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA (K013286) | Tillotson Healthcare Corp. | 2001-10-12 |
| OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM (K012402) | Omnigrace (Thailand) , Ltd. | 2001-10-12 |
| HELIX HYDRO-JET (K012464) | Andreas Pein Medizintechnik GmbH | 2001-10-10 |
| AUTO-LOCK (K010477) | Auto-Lock | 2001-10-09 |
| ANIMEC, MODELS AM-2S-4 AND AM-2S-5 (K012906) | Elltec Co., Ltd. | 2001-10-09 |
| DISPOSABLE POWDERED VINYL EXAMINATION GLOVES (K012710) | Shijiazhuang Brilliance Plastic Co., Ltd. | 2001-10-04 |
| GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C (K012383) | Alaris Medical Systems, Inc. | 2001-10-02 |
| SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE (K013104) | Sterling Medivations, Inc. | 2001-10-02 |
| SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE (K012283) | Safegard Medical Products, Inc. | 2001-10-01 |
| DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K012876) | Wrp Specialty Products Sdn. Bhd. | 2001-10-01 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN) (K012709) | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2001-10-01 |
| POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) (K012786) | Shamrock Manufacturing Company | 2001-10-01 |
| BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS (K012335) | Albert Browne , Ltd. | 2001-10-01 |
| EXEL INJECTION PLUG WITH CAP (K011405) | Exelint Intl. Co. | 2001-09-27 |
| POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5 (K011961) | Shen Wei (Usa), Inc. | 2001-09-26 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM (K012149) | Allegiance Healthcare Corp. | 2001-09-24 |
| NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K012863) | Sgmp Co., Ltd. | 2001-09-21 |
| NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED AND PROTEIN CONTENT CLAIM (50 MICROGRAMS O (K012857) | Sgmp Co., Ltd. | 2001-09-21 |
| PRE-POWDERED NITRILE EXAMINATION GLOVES (K010232) | P.T. Healthcare Glovindo | 2001-09-21 |
| POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G) (K012860) | Sgmp Co., Ltd. | 2001-09-21 |
| HORIZON OUTLOOK WITH DOSECOM (K011975) | B.Braun Medical, Inc. | 2001-09-19 |
| BIFURCATED VACCINATING NEEDLE (K012515) | Precision Medical Products, Inc. | 2001-09-19 |
| ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE (K011087) | Orthovita, Inc. | 2001-09-19 |
| GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE (K012899) | Best Manufacturing Company | 2001-09-18 |
| DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K012711) | Shijiazhuang Brilliance Plastic Co., Ltd. | 2001-09-18 |
| INFARED EAR THERMOMETER, MODEL TH8 SERIES (K011059) | Radiant Innovation, Inc. | 2001-09-17 |
| POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE (K011613) | Shield Gloves Manufacturer (M) Sdn Bhd | 2001-09-17 |
| POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS (K012558) | Matang Mfg. Sdn. Bhd. | 2001-09-17 |
| ALLERSHARP ALLERGY SKIN TESTER (K011979) | Hmb Medical Concepts, Ltd. | 2001-09-14 |
| BIOTEQUE SCALP VEIN SET (K012526) | Bioteque Corp. | 2001-09-14 |
| SIMPLICITY SOFT QD MICRO INFUSION SET (K012845) | Sterling Medivations, Inc. | 2001-09-14 |
| SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 (K012266) | National Custom Ent., Inc. | 2001-09-12 |
| BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC (K012262) | National Custom Ent., Inc. | 2001-09-12 |
| MEDFUSION 2001 & 2010, MODEL N7215IWC (K012259) | National Custom Ent., Inc. | 2001-09-12 |
| TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K011045) | Shen Wei (Usa), Inc. | 2001-09-11 |
| LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO (K011407) | Sempermed USA, Inc. | 2001-09-11 |
| HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE (K011242) | Acusupply, Inc. | 2001-09-11 |
| CHURCHILL MEDICAL SYSTEMS STOPCOCK (K012157) | Churchill Medical Systems, Inc. | 2001-09-11 |
| POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100; POLY PER-Q-CATH DUAL LUMEN PICC CATHETER, MODEL 3246100 (K012902) | C.R. Bard, Inc. | 2001-09-10 |
| TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER (K011044) | Shen Wei (Usa), Inc. | 2001-09-10 |
| SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC (K012229) | National Custom Ent., Inc. | 2001-09-10 |
| PRESSURE ACTIVATED CHECK VALVE (K011888) | Churchill Medical Systems, Inc. | 2001-09-10 |
| AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER (K012136) | Avita Corporation | 2001-09-10 |
| CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC (K012573) | Getinge/Castle, Inc. | 2001-09-05 |
| JMS APHERESIS NEEDLE SET ACCORDION TYPE (K002394) | Jms Co., Ltd. | 2001-09-05 |
| ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS (K011868) | Debio Tech SA | 2001-09-04 |
| EXEL I.V. ADMINISTRATION SET (K010404) | Exelint Intl. Co. | 2001-08-30 |
| SOLO-SAFE SAFETY SYRINGE, SIZE-3CC (K003555) | Spectrum Biotech, Inc. | 2001-08-29 |
| BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET (K011984) | Becton, Dickinson & CO | 2001-08-29 |
| BI-PHASIC INFILTRATOR (K012044) | Reliance Medical Corp. | 2001-08-28 |
| TRULINE INFUSION CATHETERS (K011937) | Micro Therapeutics, Inc. | 2001-08-28 |
| TERUMO 30 GAUGE HYPODERMIC NEEDLE (K012646) | Terumo Medical Corp. | 2001-08-27 |
| EZ SET INFUSION SET (K012754) | Animas Corp. | 2001-08-27 |
| LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS (K011749) | Sempermed USA, Inc. | 2001-08-22 |