| POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K011884) | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-17 |
| ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 (K011853) | Bio-Rad | 2001-07-17 |
| SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K011885) | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-16 |
| LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 (K011867) | Bio-Rad | 2001-07-12 |
| 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 |
| EASY CONTROL MICRO INSERTER, MODEL ON385 (K011498) | Ophtec USA, Inc. | 2001-07-09 |
| TGL FLEX REAGENT CARTRIDGE (K010871) | Dade Behring, Inc. | 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 |
| 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 |
| VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI (K011668) | Oridion Medical 1987 , Ltd. | 2001-07-09 |
| TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 (K011731) | Medical Analysis Systems, Inc. | 2001-07-05 |
| 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 |
| I-STAT SYSTEM (K011478) | I-Stat Corp. | 2001-07-02 |
| GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY (K011752) | Accufast, Inc. | 2001-06-28 |
| SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 (K011061) | W&H Dentalwerk Buermoos GmbH | 2001-06-28 |
| LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 (K011579) | Bio-Rad | 2001-06-26 |
| PORTABELL, MODEL 4200 (K011222) | Bell Dental Products, LLC | 2001-06-25 |
| BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR (K011701) | Taiwan Armada Enterprise Co., Ltd. | 2001-06-22 |
| ML BLADE, MODEL ML7030 (K010872) | Med-Logics, Inc. | 2001-06-22 |
| STRYKER T4 HYTREL (R) TOGAS (K011755) | Stryker Corp. | 2001-06-22 |
| POWDER FREE NITRILE EXAMINATION GLOVES (K010233) | P.T. Healthcare Glovindo | 2001-06-22 |
| CHESS HAND SURGERY SYSTEM (K010184) | Canica Design, Inc. | 2001-06-22 |
| MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE (K011593) | Ansell Healthcare Products, Inc. | 2001-06-21 |
| IBD-CHEK (K011396) | Techlab, Inc. | 2001-06-18 |
| CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3 (K011548) | Medical Analysis Systems, Inc. | 2001-06-18 |
| BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES (K011446) | Barriermed, Inc. | 2001-06-14 |
| CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN (K011231) | Protection Gloves Sdn. Bhd. | 2001-06-13 |
| LUNAPADS (K010986) | Lunapads International Products, Ltd. | 2001-06-13 |
| NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI (K011125) | Hudson Respiratory Care, Inc. | 2001-06-13 |
| OXYGEN SUPPLY TUBING, MODEL 1115 (K011134) | Hudson Respiratory Care, Inc. | 2001-06-13 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS (K011463) | Ortho-Clinical Diagnostics | 2001-06-13 |
| CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN) (K010854) | Protection Gloves Sdn. Bhd. | 2001-06-13 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (K011250) | Ortho-Clinical Diagnostics, Inc. | 2001-06-13 |
| IMMUNOWELL EA (D) IGG TEST (K010301) | Genbio | 2001-06-11 |
| LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL (K011494) | Bio-Rad | 2001-06-08 |
| ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER (K010862) | Allegiance Healthcare Corp. | 2001-06-07 |
| 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 |
| 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 |
| OTRES TOOTHBRUSH SANITIZER MODEL TB100W (K003517) | Otres, LLC | 2001-06-06 |
| 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 |
| 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 |
| POWDER-FREE VINYL EXAM GLOVE, YELLOW (K011413) | Heyuan Hongli Industries, Inc. | 2001-06-05 |
| POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K011474) | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-05-31 |
| NAT - NUCLEIC ACID TRANSPORT (K003761) | Medical Packaging Corp. | 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 |
| POWDER-FREE VINYL EXAM GLOVES (K011412) | Heyuan Hongli Industries, Inc. | 2001-05-31 |
| ENSIL FABRIC (K010675) | Gottfried Medical, Inc. | 2001-05-30 |
| JEWEL MPS (K011374) | Vestil Manufacturing Corp. | 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 |
| CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 (K010644) | Skil-Care Corp. | 2001-05-18 |
| HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 (K011169) | International Enzymes, Inc. | 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 |
| BREEZY WHEELCHAIR, MODEL 300 (K011268) | Sunrise Medical, Inc. | 2001-05-15 |
| 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 |
| QUICKVUE DIPSTICK STREP A (K011097) | Quidel Corp. | 2001-05-08 |
| ACON STREP A RAPID TEST STRIP (K010582) | Acon Laboratories Co. | 2001-05-07 |
| 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 |
| SURE CHECK OVULATION PREDICTOR (K010244) | Chembio Diagnostic Systems, Inc. | 2001-05-02 |
| WEISS RETINAL CANNULA (K010305) | Micron Surgical, Inc. | 2001-05-02 |
| MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS) (K010438) | Terang Nusa Sdn Bhd | 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 |
| MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) (K010439) | Terang Nusa Sdn Bhd | 2001-05-01 |
| POWDER FREE NITRILE EXAMINATION GLOVE (K011012) | Contract Latex Dippers Sdn Bhd | 2001-05-01 |
| ORTHO CONTROL FEMALE URINARY CONTROL DEVICE (K010365) | Personal Products Co. | 2001-04-30 |
| SPAZZ (K010823) | Colours 'N Motion | 2001-04-27 |
| MED-LOGICS DISPOSABLE ALK TUBING (K010353) | Med-Logics, Inc. | 2001-04-27 |
| HANSATOME MICROKERATOME (K010260) | Bausch & Lomb, Inc. | 2001-04-27 |
| URS-1K (KETONE TESST) (K003987) | Teco Diagnostics | 2001-04-26 |
| ACTIVHEAL SCAR MANAGEMENT DRESSING (K010245) | Advanced Medical Solutions, Ltd. | 2001-04-25 |
| TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (K003558) | Siemens Hearing Instruments, Inc. | 2001-04-24 |
| 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 |
| POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K010628) | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-04-23 |
| WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 (K010421) | Wiener Laboratories Saic | 2001-04-13 |
| LACTOSORB ETHMOID STENT (K002131) | Walter Lorenz Surgical, Inc. | 2001-04-13 |
| VIGIL DNASE B CONTROL (K010693) | Beckman Coulter, Inc. | 2001-04-11 |
| 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 |
| 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 |