| RIGID GAS PERMEABLE CONTACT LENS (K000795) | Polymer Technology | 2000-05-26 |
| WHEELCHAIR, MODELS H001A, 4422 (K000738) | Jackson Company, LLC | 2000-05-26 |
| OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT (K001203) | The Olympus Optical Co. | 2000-05-26 |
| MODIFICATION TO KION ANESTHESIA SYSTEM (K001315) | Siemens Elema AB | 2000-05-26 |
| IIVS INTEGRATED IMAGE VIEWING STATION (K994329) | Terarecon,Inc. | 2000-05-26 |
| DINAMAP ADVANCED NIBP MODULE (K000500) | Critikon Company, LLC | 2000-05-26 |
| CANDELA GENTLELASE GL DERMATOLOGICAL LASER (K994260) | Candela Corp. | 2000-05-26 |
| SWIVEL ELBOW (K000215) | Engineered Medical Systems | 2000-05-26 |
| LIBERTY 9000 BREAST COIL (K000993) | Usa Instruments, Inc. | 2000-05-26 |
| MODIFICATION TO ACCUDEXA BONE DENSITOMETER (K001429) | Schick Technologies, Inc. | 2000-05-26 |
| VISIONARY 2000 (K000639) | Burton Medical Products Corp. | 2000-05-25 |
| IVC TWO MEDIUM (K000937) | Invitrocare, Inc. | 2000-05-25 |
| LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 (K001373) | Bio-Rad | 2000-05-25 |
| DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES (K993777) | R-Group Intl. | 2000-05-25 |
| SYNTHETIC GLASS BONE GRAFT MATERIAL (K000633) | Blue Sky Bio | 2000-05-25 |
| NELSON WATER SYSTEMS FOR HEMODIALYSIS (K993877) | Nelson Environmental Technologies, Inc. | 2000-05-25 |
| ABBOTT IMX GLYCATED HEMOGLOBIN II (K992085) | Abbott Laboratories | 2000-05-25 |
| KROM-ALGINATE AND ALGINATE PLUS (K000686) | Cavex Holland BV | 2000-05-25 |
| Q-HTF, CAT# 2001 (K993484) | Invitrocare, Inc. | 2000-05-25 |
| VISION ESTHETIC PORCELAIN SYSTEM (K000680) | Midatlantic Division of Dentrex, Inc. | 2000-05-25 |
| IVC ONE MEDIUM (K000938) | Invitrocare, Inc. | 2000-05-25 |
| CONTROL PLASMA N (K001256) | Dade Behring, Inc. | 2000-05-24 |
| ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS (K000958) | Elan Holdings, Inc. | 2000-05-24 |
| GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11 (K000645) | General Electric Medical Systems Information Techn | 2000-05-24 |
| DORNIER MEDILAS H (K001243) | Dornier Surgical Products, Inc. | 2000-05-24 |
| HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 (K993355) | Hudson Respiratory Care, Inc. | 2000-05-24 |
| PROTON VISION (K000922) | Varian Assoc., Inc. | 2000-05-24 |
| WAKO LIPASE CALIBRATOR (K001002) | Wako Chemicals USA, Inc. | 2000-05-24 |
| BIOSCANNER TRIGLYCERIDES TEST STRIPS (K991894) | Polymer Technology Systems, Inc. | 2000-05-24 |
| ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX (K001346) | St. Jude Medical, Inc. | 2000-05-24 |
| REACH FEMORAL COMPONENT (K000760) | Biomet, Inc. | 2000-05-23 |
| GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING) (K994426) | Pt. Wrp Buana Multicorpora | 2000-05-23 |
| RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 (K000108) | Bhk Holding | 2000-05-23 |
| SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN) (K001035) | Trek Diagnostic Systems, Inc. | 2000-05-23 |
| POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS) (K001327) | Premier Pathway Sdn. Bhd. | 2000-05-23 |
| COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE (K001042) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2000-05-23 |
| NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN (K000178) | Terang Nusa Sdn Bhd | 2000-05-23 |
| AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD (K001041) | Wieland Edelmetalle GmbH & Co. | 2000-05-23 |
| POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE (K001190) | Kossan Latex Industries(M)Sdn Bhd | 2000-05-23 |
| PASS SPINAL SYSTEM (K001024) | Encore Orthopedics, Inc. | 2000-05-23 |
| XIA SPINE SYSTEM HOOKS (K001319) | Howmedica Osteonics Corp. | 2000-05-23 |
| HOFFMANN II EXTERNAL FIXATION SYSTEM (K000957) | Howmedica Osteonics Corp. | 2000-05-23 |
| SCANDINAVIAN IVF SCIENCES AB, G1.2 (K000625) | Vitrolife AB/Scandinavian Ivf Sciences AB | 2000-05-23 |
| DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR (K001065) | Sheen More Ent. Co., Ltd. | 2000-05-23 |
| HME-BOOSTER (K990614) | King Systems Corp. | 2000-05-23 |
| NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT (K000604) | Naturopathic Laboratories International, Inc. | 2000-05-23 |
| NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE (K001128) | Shanghai Poseidon Plastic Products Co., Ltd. | 2000-05-23 |
| DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR (K001155) | Sheen More Ent. Co., Ltd. | 2000-05-23 |
| NEER III TOTAL SHOULDER SYSTEM (K994350) | Smith & Nephew, Inc. | 2000-05-23 |
| EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM (K001358) | Ebi, L.P. | 2000-05-23 |
| CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ (K001307) | Implex Corp. | 2000-05-23 |
| VINYL PATIENT EXAMINATION GLOVES-POWDER FREE (K994098) | Evergreen Medical Produts (Jingxing) Co., Ltd. | 2000-05-23 |
| FOWLER ENDOCURETTE, MODEL CUR-XXX (K000974) | Utah Medical Products, Inc. | 2000-05-23 |
| CARDTEL, MODEL NT-100 (K000609) | Cardiac Telecommunications | 2000-05-23 |
| NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001 (K993921) | Ndd Medical Technologies | 2000-05-23 |
| PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH (K001122) | ETHICON, Inc. | 2000-05-23 |
| GEIGER NEEDLE ADAPTER, MODEL 406 (K001029) | Geiger Medical Technologies, Inc. | 2000-05-23 |
| SCANDINAVIAN IVF SCIENCES AB, GAMETE-100 (K000626) | Vitrolife AB/Scandinavian Ivf Sciences AB | 2000-05-23 |
| GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS) (K001049) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2000-05-23 |
| VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 (K993319) | bioMerieux, Inc. | 2000-05-22 |
| SPORTSIGHT GP (K993586) | Paragon Vision Sciences | 2000-05-22 |
| GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K000930) | Oxoid , Ltd. | 2000-05-22 |
| ETEST GATIFLOXACIN (K000596) | Ab Biodisk | 2000-05-22 |
| NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY (K993131) | Primus, Inc. | 2000-05-22 |
| THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K000879) | Zeus Scientific, Inc. | 2000-05-22 |
| MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K000999) | Multisafe Sdn. Bhd. | 2000-05-22 |
| THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K000880) | Zeus Scientific, Inc. | 2000-05-22 |
| ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL (K000729) | Arrow Intl., Inc. | 2000-05-19 |
| MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 (K994188) | Agilent Technologies, GmbH | 2000-05-19 |
| SOFTFORM FACIAL IMPLANT (K000849) | Tissue Technologies, Inc. | 2000-05-19 |
| PROAIR 3000 COMPRESSION SYSTEM (K993758) | Medical Compression Systems (Dbn) , Ltd. | 2000-05-19 |
| MENICON SF-P (K000233) | Menicon Co, Ltd. | 2000-05-19 |
| MALE LATEX COMDOM WITH DOTTED SURFACE (K001221) | Pleasure Latex Products Sdn. Bhd. | 2000-05-19 |
| METHAFILCON A (K001090) | CooperVision, Inc. | 2000-05-19 |
| C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO (K000894) | Dental Ventures of America, Inc. | 2000-05-19 |
| DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (K000704) | Dmc Medical, Ltd. | 2000-05-19 |
| WALLSTENT BILIARY ENDOPROSTHESIS (K000308) | Boston Scientific Corp | 2000-05-19 |
| POLYMACON (K001089) | CooperVision, Inc. | 2000-05-19 |
| CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) (K000637) | Alcon Laboratories, Inc. | 2000-05-19 |
| MENICON Z (K000133) | Menicon U.S.A., Inc. | 2000-05-19 |
| HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) (K000723) | Rochester Medical Corp. | 2000-05-19 |
| ROVERS ENDOCERVEX-BRUSH (K001119) | Rovers Medical Devices B.V. | 2000-05-19 |
| KAWASUMI LABORATORY BLOOD DRAWING KIT (K001043) | Kawasumi Laboratories America, Inc. | 2000-05-19 |
| FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 (K001086) | Diagnostic Systems Laboratories, Inc. | 2000-05-18 |
| ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED (K001335) | Exactech, Inc. | 2000-05-18 |
| MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS (K001451) | DePuy Orthopaedics, Inc. | 2000-05-18 |
| INTRACOIL STENT (K001257) | Intratherapeutics, Inc. | 2000-05-18 |
| HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE (K992543) | Hewlett-Packard Co. | 2000-05-18 |
| STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER (K000611) | Bd Biosciences | 2000-05-18 |
| THE CARDIAC READER SYSTEM (K000784) | Roche Diagnostics Corp. | 2000-05-18 |
| APEXPRO TELEMETRY SYSTEM (K000779) | General Electric Medical Systems Information Techn | 2000-05-18 |
| ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM (K000903) | Bayer Corp. | 2000-05-18 |
| EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO (K001237) | Micro Therapeutics, Inc. | 2000-05-18 |
| MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER (K992320) | Boston Scientific Corp | 2000-05-18 |
| PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 (K001098) | Pro. Duct Health, Inc. | 2000-05-18 |
| METAL ON METAL ACETABULAR SYSTEM (K993438) | Biomet, Inc. | 2000-05-18 |
| BAYER ADVIA IMS SYSTEM; 200 + 3 (K000921) | Bayer Corp. | 2000-05-18 |
| ETEST MOXIFLOXACIN (K000298) | Ab Biodisk | 2000-05-18 |
| PALOMAR SLP 2000 (K994225) | Palomar Medical Technologies, Inc. | 2000-05-18 |
| MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW (K001308) | Agilent Technologies | 2000-05-17 |