| DIGOXIN IMMUNOASSAY (K983323) | Diagnostic Reagents, Inc. | 1998-11-12 |
| MR COMPATIBLE LEVEEN NEEDLE ELECTRODE (K982854) | Radiotherapeutics Corp. | 1998-11-10 |
| DIAPACT CRRT (K973322) | B.Braun Medical, Inc. | 1998-11-10 |
| CMS-2000 (K982843) | Industrial Technology Research Institute | 1998-11-10 |
| REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME (K983603) | Radionics, Inc. | 1998-11-10 |
| HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282 (K982876) | Guidant Corp. | 1998-11-10 |
| ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER (K983736) | Brasamerica Medical Equipment, Inc. | 1998-11-10 |
| ALLDRESS, ABSORBENT FILM DRESSING (K983554) | Molnlycke Health Care, Inc. | 1998-11-10 |
| RESPIRATORY HUMIDIFIER, MODEL # MR850 (K983112) | Fisher & Paykel Healthcare, Ltd. | 1998-11-10 |
| DIGITAL ECG HOLTER RECORDER, MODEL DR512 (K982975) | Datrix | 1998-11-10 |
| PERIPHERAL NERVE STIMULATION (K982902) | Medtronic Vascular | 1998-11-10 |
| ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE (K983033) | Guidant Corp. | 1998-11-10 |
| ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON (K983478) | Organic Essentials | 1998-11-09 |
| FIBREKOR POST SYSTEM (K983266) | Jeneric/Pentron, Inc. | 1998-11-09 |
| BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING (K982840) | Boston Scientific Corp | 1998-11-09 |
| BRENEB (K982043) | Bremed Italia, S.R.L. | 1998-11-09 |
| CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 (K982167) | Coulter Corp. | 1998-11-09 |
| C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 (K981871) | Diagnostic Systems Laboratories, Inc. | 1998-11-09 |
| LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL (K980800) | Cosmedent, Inc. | 1998-11-09 |
| ALPHATRAC, MODEL A200 (K982815) | Teftec Corp. | 1998-11-06 |
| OCU-GUARD AND OCU-GUARD SUPPLE (K983581) | Bio-Vascular, Inc. | 1998-11-06 |
| QUICKIE G SERIES, MODEL G-424 (K983677) | Sunrise Medical, Inc. | 1998-11-06 |
| SIEMENS SC 8000 BEDSIDE MONITOR (K983632) | Siemens Medical Solutions USA, Inc. | 1998-11-06 |
| MESH, SURGICAL, POLYMERIC (K982575) | United States Surgical, A Division of Tyco Healthc | 1998-11-06 |
| POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR (K982110) | Optech, Inc. | 1998-11-06 |
| FORTE, MODEL CPS ULTRASOUND (K982829) | Chattanooga Group, Inc. | 1998-11-06 |
| ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50 (K983405) | Aceme Technologies Intl. | 1998-11-06 |
| CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS (K983141) | Johnson & Johnson Professionals, Inc. | 1998-11-06 |
| ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F (K983407) | Aceme Technologies Intl. | 1998-11-06 |
| ACE ALVEOLAR DISTRACTOR (K981526) | Ace Surgical Supply Co., Inc. | 1998-11-06 |
| DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS (K983684) | Datex-Ohmeda, Inc. | 1998-11-06 |
| VANCOMYCIN EIA ASSAY (K983280) | Diagnostic Reagents, Inc. | 1998-11-06 |
| SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM (K983283) | Signet Radiology, Inc. | 1998-11-06 |
| NATURALYTE, MODEL # 08-4004-1 (K982813) | Kaybath, Inc. | 1998-11-06 |
| BRENNEN MEDICAL BETA GLUCAN GEL (K982825) | Brennen Medical, Inc. | 1998-11-06 |
| FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO (K982830) | Chattanooga Group, Inc. | 1998-11-06 |
| LOW PH PHENOLIC 256 (K983585) | Central Solutions, Inc. | 1998-11-06 |
| ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT (K980999) | Instrument Makar, Inc. | 1998-11-06 |
| BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD (K983520) | Sunrise Medical, Inc. | 1998-11-06 |
| MEGA 2000 (K982826) | Megadyne Medical Products, Inc. | 1998-11-06 |
| QLICKSMART (K983367) | Handren Assoc. | 1998-11-06 |
| ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR (K980895) | California Institute of Tissue Eng. & Instrumenti | 1998-11-06 |
| SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE (K982410) | Rehabilicare, Inc. | 1998-11-06 |
| VINYL EXAMINATION GLOVES, POWDER FREE (K982933) | General Gloves Corp. | 1998-11-06 |
| QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300 (K981462) | Sunrise Medical, Inc. | 1998-11-06 |
| XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT (K983025) | Xomed, Inc. | 1998-11-06 |
| FORTE, MODELS CPS 400 STIM, CPS 200 STIM (K982828) | Chattanooga Group, Inc. | 1998-11-06 |
| MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY (K983538) | Solos Endoscopy, Inc. | 1998-11-06 |
| PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR (K973585) | Propper Mfg. Co., Inc. | 1998-11-06 |
| TRITON HUDSON CHUCK ATTACHMENT (K983092) | Mednext, Inc. | 1998-11-06 |
| KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS (K982837) | Karl Storz Endoscopy | 1998-11-06 |
| N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE (K983218) | Avid N.I.T., Inc. | 1998-11-06 |
| IRRIGATION SYRINGE KIT (K982435) | Sub-Q, Inc. | 1998-11-06 |
| MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE (K983287) | Graphic Controls Corp. | 1998-11-05 |
| MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7 (K982821) | Multimedia Medical Systems, Inc. | 1998-11-05 |
| DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS (K983159) | Diagnostic Reagents, Inc. | 1998-11-05 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT (K983151) | Beckman Coulter, Inc. | 1998-11-05 |
| EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK (K983608) | Yty Industry (Manjung) Sdn Bhd | 1998-11-05 |
| INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS) (K980129) | Richard Wolf Medical Instruments Corp. | 1998-11-05 |
| POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES (K983612) | Shanghai Jiatai Plastic Products Co., Ltd. | 1998-11-05 |
| POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES (K981064) | P.T. Irama Dinamika Latex | 1998-11-05 |
| COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE (K980756) | Ge Medical Systems Information Technologies | 1998-11-05 |
| H-RAY (K982720) | Shijiazhuang Hongray Plastic Products Co., Ltd. | 1998-11-05 |
| VINYL EXAM GLOVES, POWDER FREE (K983494) | Glormed Intl., Inc. | 1998-11-05 |
| CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 (K982166) | Coulter Corp. | 1998-11-05 |
| SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT (K983304) | Synermed Intl., Inc. | 1998-11-04 |
| SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I (K983209) | Beckman Coulter, Inc. | 1998-11-04 |
| HELAX-IMCON, VERSION 1.0 (K982857) | Helax AB | 1998-11-04 |
| COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET (K982760) | Gambro Healthcare | 1998-11-04 |
| CT BIOPSYVIEW (K983140) | Philips Medical Systems North America, Inc. | 1998-11-04 |
| AUTOVENT 1500 (K983857) | O-Two Systems Intl., Inc. | 1998-11-04 |
| QUANTA LITE H. PYLORI IGG ELISA (K982790) | Inova Diagnostics, Inc. | 1998-11-04 |
| QUANTA LITE RF IGA ELISA (K983084) | Inova Diagnostics, Inc. | 1998-11-04 |
| BIO-2000 (K973765) | Micrylium Laboratories | 1998-11-04 |
| IGA (K983359) | Abbott Laboratories | 1998-11-04 |
| C3 (K983441) | Abbott Laboratories | 1998-11-04 |
| STRATUS CS TROPONIN I CALIBRATOR (K983722) | Dade Behring, Inc. | 1998-11-04 |
| TRF (K983167) | Abbott Laboratories | 1998-11-04 |
| SPIFE URINE IFE (K982639) | Helena Laboratories | 1998-11-04 |
| SILHOUETTE VR (K982955) | GE Medical Systems | 1998-11-04 |
| DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR (K983693) | Dade Behring, Inc. | 1998-11-04 |
| AUTO-LYTE PCP EIA, MODEL #1254U (K982801) | OraSure Technologies, Inc. | 1998-11-04 |
| C4 (K983356) | Abbott Laboratories | 1998-11-04 |
| IGM (K983132) | Abbott Laboratories | 1998-11-04 |
| BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70) (K971616) | Data Sciences Intl., Inc. | 1998-11-04 |
| CANON X-RAY DIGITAL CAMERA CXDI-11 (K981556) | Canon USA, Inc. | 1998-11-04 |
| CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 (K982838) | Sims Deltec, Inc. | 1998-11-04 |
| DIGIRAD 2020TC SPECT IMAGING SYSTEM (K982855) | Digirad Corp. | 1998-11-04 |
| ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS (K983285) | Engle Dental Systems | 1998-11-04 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY (K983507) | Ortho-Clinical Diagnostics, Inc. | 1998-11-04 |
| QUANTA LITE RF IGG ELISA (K983083) | Inova Diagnostics, Inc. | 1998-11-04 |
| IGG (K983221) | Abbott Laboratories | 1998-11-04 |
| SUPER PORCELAIN ADDMATE (K983247) | Noritake Co., Inc. | 1998-11-03 |
| MITRA IMAGING INC. EXHIBIT (K982769) | Mitra Imaging, Inc. | 1998-11-03 |
| DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 (K981378) | Datex-Engstrom, Inc. | 1998-11-03 |
| MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA (K982921) | Medrad, Inc. | 1998-11-03 |
| EPIFILM OTOLOGIC LAMINA (K982870) | Xomed, Inc. | 1998-11-03 |
| MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700 (K983562) | Cdc Technologies, Inc. | 1998-11-03 |
| BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION (K982775) | Bausch & Lomb, Inc. | 1998-11-03 |
| MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC (K982959) | Medrad, Inc. | 1998-11-03 |