| RX EVEREST (K001051) | Jeneric/Pentron, Inc. | 2000-04-28 |
| KERR GEL ETCHANT (K000954) | Sybron Dental Specialties, Inc. | 2000-04-28 |
| PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP (K000542) | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-28 |
| CORDIS INTRODUCER GUIDE (K001136) | Cordis Corp. | 2000-04-28 |
| MEDTRONIC MODEL 7499 EXTENSION (K000445) | Medtronic Vascular | 2000-04-28 |
| OPTI-FREE EXPRESS LENS DROPS (K000385) | Alcon Universal, Ltd. | 2000-04-28 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM (K000667) | Protection Gloves Sdn. Bhd. | 2000-04-28 |
| STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES (K000891) | Fitco Dipped Products Pvt., Ltd. | 2000-04-28 |
| POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 (K993564) | Possis Medical, Inc. | 2000-04-28 |
| EROS-CLITORAL THERAPY DEVICE (CTD) (DEN000006) | Urometrics, Inc. | 2000-04-28 |
| MODEL 120 (K994372) | Palco Labs, Inc. | 2000-04-28 |
| GT990402 DIGITAL THERMOMETER (K001279) | Global Treasure , Ltd. | 2000-04-28 |
| POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K001216) | Fitco Dipped Products Pvt., Ltd. | 2000-04-28 |
| HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES (K993756) | Pamitex Industries Sdn Bhd | 2000-04-28 |
| SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM (K000684) | Synthes (Usa) | 2000-04-28 |
| 8100 VITAL SIGNS MONITOR (K001020) | Criticare Systems, Inc. | 2000-04-28 |
| GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) (K001047) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2000-04-28 |
| GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE (K001270) | Gyrus Medical , Ltd. | 2000-04-28 |
| UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES (K000689) | N.S. Uni-Gloves Sdn. Bhd. | 2000-04-28 |
| SILK NONABSORBABLE SURGICAL SUTURES, USP (K000541) | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-28 |
| SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES (K001094) | Jb Star Sdn Bhd | 2000-04-28 |
| DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D (K000299) | Biomedex, Inc. | 2000-04-28 |
| PORTABLE INTENSIVE CARE UNIT, MODEL PIC (K000712) | Medical Research Laboratories, Inc. | 2000-04-27 |
| UMBICUT (K000227) | Pollak (Intl.), Ltd. | 2000-04-27 |
| POLYESTER NONABSORBABLE SURGICAL SUTURES, USP (K000540) | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-27 |
| STEROTACTIC LOCALIZATION DEVICE (SLD) (K000832) | Philips Medical Systems North America, Inc. | 2000-04-27 |
| CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 (K000942) | Sims Deltec, Inc. | 2000-04-27 |
| AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 (K001138) | Medtronic Vascular | 2000-04-27 |
| THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE (K001006) | Mds Nordion | 2000-04-27 |
| ASCENT KNEE REVISION FEMORAL STEM (K001010) | Biomet, Inc. | 2000-04-27 |
| NYLON NONABSORBABLE SURGICAL SUTURES, USP (K000539) | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-27 |
| ELECSYS THYROGLOBULIN CALCHECK (K001015) | Roche Diagnostics Corp. | 2000-04-27 |
| LIGHT BOND (QUICK CURE) (K001048) | Reliance Orthodontic Products, Inc. | 2000-04-27 |
| TI500 GLOBE-TROTTER TRANSPORT SYSTEM (K001019) | Hill-Rom Air-Shields | 2000-04-27 |
| POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP (K000537) | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-27 |
| HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER (K000701) | The Binding Site, Ltd. | 2000-04-27 |
| MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE (K994171) | Medtronic Cardiac Surgical Products | 2000-04-27 |
| BIOLOK SCREW (K993630) | Encore Orthopedics, Inc. | 2000-04-26 |
| REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT (K000920) | Corgenix, Inc. | 2000-04-26 |
| DELTALOC ANTERIOR CERVICAL PLATE SYSTEM (K993513) | Alphatec Mfg., Inc. | 2000-04-26 |
| K-ASSAY AT-III (K000361) | Kamiya Biomedical Co. | 2000-04-26 |
| EMBOSPHERE MICROSPHERES (K991549) | Biosphere Medical | 2000-04-26 |
| ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 (K000096) | Roche Diagnostics Corp. | 2000-04-26 |
| VITAPORT 3 (K000338) | Nihon Kohden America, Inc. | 2000-04-26 |
| LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 (K001021) | Dideco S.P.A. | 2000-04-25 |
| MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (K000762) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000-04-25 |
| STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 (K000964) | Automatic Liquid Packaging, Inc. | 2000-04-25 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K000649) | Dade Behring, Inc. | 2000-04-25 |
| MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET (K001118) | DiaSorin, Inc. | 2000-04-25 |
| COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR (K000255) | Cobe Cardiovascular, Inc. | 2000-04-25 |
| HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01 (K994023) | Haemacure Corp. | 2000-04-25 |
| DATES-OHMEDA AESTIVA SMARTVENT MRI (K993410) | Datex-Ohmeda, Inc. | 2000-04-25 |
| ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER (K000297) | Erchinger Medizintecnik | 2000-04-24 |
| GE LOGIQ 700 (K001016) | GE Medical Systems | 2000-04-24 |
| SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST (K000452) | Drug Detection Devices, Ltd. | 2000-04-24 |
| MEDVIZER PACS, MODEL RELEASE 2000 (K000557) | Vitel Net | 2000-04-24 |
| RESPONSE 2000 CEMENTED HIP STEM (K000432) | DePuy Orthopaedics, Inc. | 2000-04-24 |
| VISION R/F TILTING TABLE (K000412) | Villa Sistemi Medicali S.P.A. | 2000-04-24 |
| MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS (K001105) | Depuyacromed | 2000-04-24 |
| MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS (K000985) | Matang Mfg. Sdn. Bhd. | 2000-04-24 |
| LORAD LT-100 LASER TREATMENT SYSTEM (K992597) | Focus Medical, LLC | 2000-04-24 |
| RESPONSE 2000 HIP STEM (K000392) | DePuy Orthopaedics, Inc. | 2000-04-24 |
| EVERSHEARS BIPOLAR SCISSORS (K000496) | Everest Medical Corp. | 2000-04-24 |
| REMOTE FETAL MEDICINE ULTRASOUND SYSTEM (K000443) | R4 Telemedicine, Inc. | 2000-04-24 |
| ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE (K000612) | Inrad | 2000-04-24 |
| VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 (K001133) | Ortho-Clinical Diagnostics, Inc. | 2000-04-24 |
| MODIFICATION TO CONVERTORS SURGICAL GOWNS (K001189) | Allegiance Healthcare Corp. | 2000-04-21 |
| CAVERMAP SURGICAL AID (K000507) | Uromed Corp. | 2000-04-21 |
| BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP (K993871) | Allegiance Healthcare Corp. | 2000-04-21 |
| DEVILBISS NEBULIZER MODEL 800 (K993492) | Sunrise Medical Hhg, Inc. | 2000-04-21 |
| POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR (K000867) | Sgmp Co., Ltd. | 2000-04-21 |
| MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM (K000444) | Prism Enterprises, Inc. | 2000-04-21 |
| 3D MANUAL COARSE MANIPULATOR MN-188NE (K001130) | Narishige Co., Ltd. | 2000-04-21 |
| MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS (K000956) | Boston Scientific Scimed, Inc. | 2000-04-21 |
| KSEA CHARDONNES MORCELLATION KNIFE (K000212) | KARL STORZ Endoscopy-America, Inc. | 2000-04-21 |
| KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 (K001123) | Heinz Kurz GmbH Medizintechnik | 2000-04-21 |
| 3D HDRAULIC FINE MICROMANIPULATOR MO-188NE (K001131) | Narishige Co., Ltd. | 2000-04-21 |
| OPART, MODEL MRT-600 (K000549) | Toshiba America Mri, Inc. | 2000-04-20 |
| PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E (K001102) | Rd Medical Mfg., Inc. | 2000-04-20 |
| ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 (K000875) | Bio-Rad | 2000-04-20 |
| PACSSTATION (K000448) | Fernandez Industries, Inc. | 2000-04-20 |
| DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K000953) | Shanghai Antares Industries, Inc. | 2000-04-20 |
| NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES (K000868) | Sgmp Co., Ltd. | 2000-04-20 |
| BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER (K000247) | Bausch & Lomb, Inc. | 2000-04-20 |
| STERILE WATER & STERILE 0.9% SODIUM CHLORIDE (K992732) | Dumex Medical Surgical Products, Ltd. | 2000-04-20 |
| BETEL POWDER FREE LATEX EXAM GLOVES (K000650) | Betel Care Sdn. Bhd. | 2000-04-20 |
| CRANIAL DRILL (K000195) | Image-Guided Neurologics, Inc. | 2000-04-20 |
| COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES (K993356) | Coulter Corp. | 2000-04-20 |
| PICO SMOKERLYZER, MODEL EC-50 (K000962) | Bedfont Scientific, Ltd. | 2000-04-20 |
| FRIALIT-2 MH-2 ABUTMENT (K994174) | Friadent GmbH | 2000-04-20 |
| UM-L25 (K000222) | Union Medical Engeneering Co., Ltd. | 2000-04-19 |
| VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM (K000936) | Mitek Products | 2000-04-19 |
| LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM (K000408) | Suretex Prophylactics , Ltd. | 2000-04-19 |
| OIL FOR TISSUE CULTURE (K991380) | Advanced Reproductive Technologies | 2000-04-19 |
| MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT (K993268) | Mallinckrodt Dar S.R.L. | 2000-04-19 |
| HYSTALOG HSG CATHETER (K000340) | Rocket Medical Plc | 2000-04-19 |
| THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 (K000478) | Accuray, Inc. | 2000-04-19 |
| AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE (K000961) | Aaron Medical Industries | 2000-04-19 |
| VIEW NT (K000474) | Electromed Intl., Ltd. | 2000-04-19 |
| LIFECARD CF COMPACT RECORDER (K001025) | Reynolds Medical , Ltd. | 2000-04-19 |