| GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM (K991156) | Great Smokies Diagnostic Laboratory | 1999-05-28 |
| REUSABLE CONTOUR II NASAL MASK (K991648) | Respironics, Inc. | 1999-05-28 |
| GC RELINE SOFT/EXTRA SOFT (K990736) | GC America, Inc. | 1999-05-28 |
| GBACT + KIT (K984141) | Sienco, Inc. | 1999-05-28 |
| ISOLOCK SPINAL SYSTEM (K990721) | Scien'Tx USA, Inc. | 1999-05-27 |
| CHROMOPHARE D500, D530, D650 (K991527) | Berchtold Holding GmbH | 1999-05-27 |
| ELECTRODE NEEDLES (K990015) | Technomed Europe | 1999-05-27 |
| DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (K990875) | Dermaphylyx, Inc. | 1999-05-27 |
| E-SCAN (K990968) | Biosound Esaote, Inc. | 1999-05-27 |
| INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 (K990663) | Medtech , Ltd. | 1999-05-27 |
| STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM (K991703) | Stryker Instruments | 1999-05-27 |
| GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER (K990753) | Cook, Inc. | 1999-05-27 |
| SURGISORB (K990432) | Sutures , Ltd. | 1999-05-27 |
| MILLENNIUM (K990908) | Endo Technic Corp. | 1999-05-27 |
| NORMAL SALINE FLUSH SYRINGE (K984614) | Rocap Div. of Sabratek Corp. | 1999-05-27 |
| MODIFICATION OF MLT R694 RUBY LASER SYSTEM (K990902) | Medical Laser Technologies , Ltd. | 1999-05-27 |
| CRIT-SCAN II MONITOR (K983551) | In-Line Diagnostics Corp. | 1999-05-27 |
| DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING (K990891) | Dermaphylyx, Inc. | 1999-05-27 |
| MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (K991635) | Computer Motion, Inc. | 1999-05-27 |
| INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER (K983604) | Washington Regulatory Services | 1999-05-27 |
| QUANTEC-E ENDO SYSTEM (K990739) | Sybron Dental Specialties, Inc. | 1999-05-26 |
| THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO (K983805) | Zeus Scientific, Inc. | 1999-05-26 |
| CORDIS TEMPO ANGIOGRAPHY CATHETER (K991673) | Cordis Corp. | 1999-05-26 |
| 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT (K991431) | Arrow Intl., Inc. | 1999-05-26 |
| TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 (K984497) | Oriental System Technology, Inc. | 1999-05-26 |
| THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH (K984120) | Zeus Scientific, Inc. | 1999-05-26 |
| SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES (K991415) | Supermax Sdn Bhd | 1999-05-26 |
| BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) (K981246) | Integra Neurocare, LLC | 1999-05-26 |
| BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (K991493) | Masju Sdn. Bhd. | 1999-05-26 |
| DIGI-SNAP (K984169) | Snap Laboratories, LLC | 1999-05-26 |
| RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) (K990963) | Riverstone Resources Sdn Bhd | 1999-05-26 |
| THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K984135) | Zeus Scientific, Inc. | 1999-05-26 |
| CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01 (K991108) | A.P. Total Care, Inc. | 1999-05-25 |
| VITRON M (K990763) | Espe Dental AG | 1999-05-25 |
| TOTAL IRON, MODELS FE 109-01, FE 109-02 (K991244) | A.P. Total Care, Inc. | 1999-05-25 |
| EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) (K991466) | Selfcare, Inc. | 1999-05-25 |
| GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02 (K990981) | A.P. Total Care, Inc. | 1999-05-25 |
| EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) (K991386) | Selfcare, Inc. | 1999-05-25 |
| BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 (K991111) | A.P. Total Care, Inc. | 1999-05-25 |
| ALBUMIN BCG, MODEL AL 103-01 (K990978) | A.P. Total Care, Inc. | 1999-05-25 |
| CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 (K991109) | A.P. Total Care, Inc. | 1999-05-25 |
| COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K990239) | Cobe Cardiovascular, Inc. | 1999-05-25 |
| BUN, MODEL BU 104-01 (K990980) | A.P. Total Care, Inc. | 1999-05-25 |
| URIC ACID, MODEL UA112-01 (K991247) | A.P. Total Care, Inc. | 1999-05-25 |
| LACTATION TECHNIQUES MODEL B (K981549) | Lactation Techniques, Inc. | 1999-05-24 |
| BERACLAMP, MODEL BC-1 (K990045) | Poamax LLC | 1999-05-24 |
| PELVX INCONTINENCE DISH, MODEL 301-306 (K990593) | Deschutes Medical Products, Inc. | 1999-05-24 |
| STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 (K990574) | Respironics, Inc. | 1999-05-24 |
| CLOUD 1 HUMIDIFICATION SYSTEM (K983862) | Respiratory Support Products, Inc. | 1999-05-24 |
| HITACHI VERSIFLEX (K991231) | Hitachi Medical Systems America, Inc. | 1999-05-24 |
| ASCENT KNEE SYSTEM (K991428) | Biomet, Inc. | 1999-05-21 |
| BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) (K990878) | Brightway Holdings Sdn. Bhd. | 1999-05-21 |
| BAYER ADVIA 1650 CHEMISTRY SYSTEM (K990346) | Bayer Corp. | 1999-05-21 |
| SMARTEMP (K991270) | Parkell, Inc. | 1999-05-21 |
| MICROGAS 7650 TRANSCUTANEOUS MONITOR (K991644) | Linde Medical Sensors AG | 1999-05-21 |
| POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K991317) | Safeskin Corp. | 1999-05-21 |
| CENTRAFIX EXTERNAL FIXATOR (K991732) | Owandar Medical, Ltd. | 1999-05-21 |
| SONOTOME (K990572) | Sonokinetics, Inc. | 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 |
| SURESTEP BLOOD GLUCOSE MONITORING SYSTEM (K984261) | Lifescan, Inc. | 1999-05-21 |
| LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 (K984328) | Elekta Instrument AB | 1999-05-21 |
| SURGEON'S GLOVES (K984395) | Sri Anusham Rubber Industries Pvt., Ltd. | 1999-05-21 |
| WALKCARE P200 SYSTEM (K973592) | A.Stein - Regulatory Affairs Consulting | 1999-05-20 |
| WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) (K983840) | Wallach Surgical Devices, Inc. | 1999-05-20 |
| POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES (K990690) | Top Glove Sdn. Bhd. | 1999-05-20 |
| TRU-CORE I REUSABLE BIOPSY INSTRUMENT (K990839) | Medical Device Technologies, Inc. | 1999-05-20 |
| VESTOGUM (K991221) | Espe Dental AG | 1999-05-20 |
| BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES (K990710) | Barriermed Glove Co. | 1999-05-20 |
| VITRON H (K991220) | Espe Dental AG | 1999-05-20 |
| IODINE BRACHYTHERAPY SEEDS, MODEL 3000 (K990193) | Implant Sciences Corp. | 1999-05-20 |
| LIFE IMAGING SYSTEMS, MODEL L3DI (K990560) | Life Imaging Systems, Inc. | 1999-05-20 |
| EXTRA LARGE BODY COIL FOR OPART (MRT-600) (K991057) | Toshiba America Mri, Inc. | 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 |
| AII-PRO 100 PLUS AND ALL-PRO 200 (K991435) | All-Pro Imaging Corp. | 1999-05-20 |
| WRIST BLOOD PRESSURE METER MODEL SE-330 (K973078) | Sein Electronics Co., Ltd. | 1999-05-20 |
| VACUTAINER BRAND CTAD TUBE (MULTIPLE) (K991120) | Becton Dickinson Vacutainer Systems | 1999-05-19 |
| ELAN ALKALINE PHOSPHATE REAGENT KIT (K991387) | Elan Holdings, Inc. | 1999-05-19 |
| VECTORVISION2 (K983831) | Brainlab AG | 1999-05-19 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS (K990016) | Ortho-Clinical Diagnostics, Inc. | 1999-05-19 |
| ACP (K991010) | Abbott Diagnostics Mfg., Inc. | 1999-05-19 |
| MODIFICATION OF N/T PROTEIN CONTROL SL (K991182) | Dade Behring, Inc. | 1999-05-19 |
| GALLINI ATRA-CUT NEEDLE (K990645) | Gallini U.S., LLC | 1999-05-19 |
| BIPAP HARMONY S/T, MODEL 1001445 (K984407) | Respironics, Inc. | 1999-05-19 |
| BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE (K990538) | Brainmaster | 1999-05-19 |
| OSTEOGRAM BONE DENSITOMETER (K984285) | Compumed, Inc. | 1999-05-19 |
| ETB TROCAR SYSTEM (K990894) | The Altomec Corp. | 1999-05-19 |
| VISTA STEREOSCOPE SYSTEM (K990635) | Vista Medical Technologies, Inc. | 1999-05-19 |
| MODIFICATION TO TENOR SPINAL SYSTEM-PLATES (K991364) | Sofamor Danek USA,Inc. | 1999-05-19 |
| DIAMOND II VALVE (K991429) | Phoenix Biomedical Corp. | 1999-05-19 |
| NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR (K991583) | The Magstim Company , Ltd. | 1999-05-19 |
| EASTGATE PERSONAL MONITOR (K990731) | Eastgate Trading Corp. | 1999-05-19 |
| MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM (K991460) | Sofamor Danek | 1999-05-19 |
| WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS (K990522) | Lamont Medical, Inc. | 1999-05-19 |
| INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE (K990493) | Innerdyne, Inc. | 1999-05-18 |
| LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET (K990672) | Hurricane Medical | 1999-05-18 |
| MODIFICATION OF:BIODERM FOAM WOUND DRESSING (K990955) | Bioderm, Inc. | 1999-05-18 |
| STAPES PROSTHESES (K991394) | Grace Medical, Inc. | 1999-05-18 |
| SIGNADRESS DUODERM DRESSING (K990964) | Convatec, A Division of E.R. Squibb & Sons | 1999-05-18 |
| THE VAULT (K990936) | Stik Stoppers, Inc. | 1999-05-18 |