| HEM-O-LOK MODEL NUMBERS 523900, 523970 (K982941) | Weck Closure Systems | 1998-11-19 |
| RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES (K982544) | Rich-Mar Corp. | 1998-11-19 |
| OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 (K983282) | Ohio Medical Instrument Co., Inc. | 1998-11-19 |
| FACTS (K982010) | Philips Medical Systems (Cleveland), Inc. | 1998-11-19 |
| MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY (K983268) | Diagnostic Reagents, Inc. | 1998-11-18 |
| PRODIGY- 3 (K983370) | Sybron Dental Specialties, Inc. | 1998-11-18 |
| AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 (K982657) | Microvena Corp. | 1998-11-18 |
| DBEST COCAINE TEST KIT (K983191) | Ameritek, Inc. | 1998-11-18 |
| G/K SFN AND STN LOCKING NAILS (K983358) | Howmedica, Inc. | 1998-11-18 |
| QUADRANT UNIBOND (K983545) | Cavex Holland BV | 1998-11-18 |
| MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN (K981199) | Dade Microscan, Inc. | 1998-11-18 |
| DIMENSION AHDL CALIBRATOR (K983850) | Dade Behring, Inc. | 1998-11-18 |
| PAINBUSTER INFUSION KIT (K982946) | I-Flow Corp. | 1998-11-18 |
| IS-ANTI-PR3 IGG ELISA TEST SYSTEM (K983740) | Columbia Bioscience, Inc. | 1998-11-18 |
| THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC (K983426) | Zeus Scientific, Inc. | 1998-11-18 |
| PROSPECT CAMPYLOBACTER MICROPLATE ASSAY (K982315) | Alexon - Trend, Inc. | 1998-11-18 |
| AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 (K983168) | Ora Innovations, Inc. | 1998-11-18 |
| THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S (K983376) | Zeus Scientific, Inc. | 1998-11-18 |
| OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS (K983669) | Radionics, Inc. | 1998-11-18 |
| DBEST OPIATES TEST KIT (K983190) | Ameritek, Inc. | 1998-11-18 |
| FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS (K983262) | Lunar Corp. | 1998-11-18 |
| ACON MIDSTREAM PREGNANCY TEST (K983090) | ACON Laboratories, Inc. | 1998-11-18 |
| AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER (K983049) | American Electromedics Corp. | 1998-11-18 |
| IS-ANTI-MPO IGG ELISA TEST SYSTEM (K983390) | Columbia Bioscience, Inc. | 1998-11-18 |
| BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS (K983894) | Bausch & Lomb, Inc. | 1998-11-18 |
| ONTRAK TESTCUP-ER (K983388) | Roche Diagnostic Systems, Inc. | 1998-11-18 |
| AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER (K983051) | American Electromedics Corp. | 1998-11-18 |
| DBEST METHAMPHETAMINES TEST KIT (K983189) | Ameritek, Inc. | 1998-11-18 |
| FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS (K983271) | Lunar Corp. | 1998-11-18 |
| ABBOTT TESTPACK PLUS H. PYLORI (K982362) | Abbott Laboratories | 1998-11-18 |
| BREATHTIQUE TONGUE SCRAPER (K983087) | Custom Medical Arts, Inc. | 1998-11-18 |
| BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT (K983113) | Syntron Bioresearch, Inc. | 1998-11-18 |
| PROCERA ALLCERAM FUSING MATERIAL (K983453) | Nobel Biocare Uas, Inc. | 1998-11-18 |
| ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES (K983174) | Roche Diagnostic Systems, Inc. | 1998-11-18 |
| AUTO-LYTE BARBITURATES EIA (K982745) | OraSure Technologies, Inc. | 1998-11-18 |
| THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET (K983425) | Zeus Scientific, Inc. | 1998-11-18 |
| DBEST TETRAHYDROCANNABINOL TEST KIT (K983188) | Ameritek, Inc. | 1998-11-18 |
| NMT SAFETY SYRINGE (K982431) | New Medical Technology , Ltd. | 1998-11-18 |
| ABBOTT ARCHITECT TESTOSTERONE (K983212) | Abbott Laboratories | 1998-11-18 |
| THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL (K983418) | Zeus Scientific, Inc. | 1998-11-18 |
| THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET (K983422) | Zeus Scientific, Inc. | 1998-11-18 |
| THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K983465) | Zeus Scientific, Inc. | 1998-11-18 |
| FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER (K983269) | Lunar Corp. | 1998-11-18 |
| THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K983423) | Zeus Scientific, Inc. | 1998-11-18 |
| CARDIAC MARKER CONTROL MODULE, MODEL CCCM (K983971) | Diagnostic Products Corp. | 1998-11-18 |
| THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO (K983420) | Zeus Scientific, Inc. | 1998-11-18 |
| THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. (K983378) | Zeus Scientific, Inc. | 1998-11-18 |
| THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K983464) | Zeus Scientific, Inc. | 1998-11-18 |
| EPIDURAL CATHETER MODELS 1210/1200 (K983125) | Rusch Intl. | 1998-11-17 |
| FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F (K983855) | Jawon Medical Co., Ltd. | 1998-11-17 |
| SOLO-CARE BRAND MULTI-PURPOSE SOLUTION (K982168) | Ciba Vision Corporation | 1998-11-17 |
| AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER (K983048) | American Electromedics Corp. | 1998-11-17 |
| AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER (K983046) | American Electromedics Corp. | 1998-11-17 |
| SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (K980551) | Nidek Medical Products, Inc. | 1998-11-17 |
| AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) (K980492) | Circon Acmi | 1998-11-17 |
| BONE INJECTION GUN (B.I.G.) DEVICE (K981853) | Waismed, Ltd. | 1998-11-17 |
| MARK 5000 PHASED ARRAY SHOULDER COIL (K983143) | Usa Instruments, Inc. | 1998-11-16 |
| 25-HYDROXYVITAMIN D 125I RIA KIT (K983617) | DiaSorin, Inc. | 1998-11-16 |
| SAFETEX CERVICAL SCRAPER (PLASTIC) (K983428) | Andwin Scientific | 1998-11-16 |
| ABBOTT AXSYM MYOGLOBIN (K983848) | Abbott Laboratories | 1998-11-16 |
| NAPA EIA ASSAY (K983812) | Diagnostic Reagents, Inc. | 1998-11-16 |
| CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM (K980045) | Invivo Research, Inc. | 1998-11-16 |
| DUREX LUBRAGEL LATEX CONDOM (K983380) | London Intl., LLC | 1998-11-16 |
| SKULL BASE INSTATRAK SYSTEM (K982994) | Visualization Technology, Inc. | 1998-11-16 |
| SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS (K983980) | Siemens Medical Solutions USA, Inc. | 1998-11-16 |
| PLANMED SOPHIE & PLANNED SOPHIE CLASSIC (K983659) | Planmed OY | 1998-11-16 |
| FORTE (K982911) | Adac Laboratories | 1998-11-16 |
| OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT) (K982610) | Olympus Optical, Co. | 1998-11-16 |
| SIGNA PROFILE SMALL HEAD COIL (K982972) | GE Medical Systems | 1998-11-16 |
| DUREX SENSIDOM LATEX CONDOM (K982924) | London Intl., LLC | 1998-11-16 |
| CYTOPREP (K983181) | Cytoprep Inc. Est. | 1998-11-16 |
| WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K980182) | Usfilter/Ionpure, Inc. | 1998-11-16 |
| XRAY VISION (K983111) | Apteryx, Inc. | 1998-11-16 |
| FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W (K983028) | Hologic, Inc. | 1998-11-13 |
| NIR BILIARY STENT (K973171) | Medinol, Ltd. | 1998-11-13 |
| STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION (K983786) | Sterngold/Implamed | 1998-11-13 |
| HEMOCOR HPH 700 HEMOCONCENTRATOR (K983085) | Minntech Corp. | 1998-11-13 |
| HEARTLINK, MODEL II (K982803) | Cardiac Telecom Corp. | 1998-11-13 |
| MUCOPREN SOFT RELINING SYSTEM (K983357) | Roydent Dental Products, Inc. | 1998-11-13 |
| METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC (K983021) | Metrosoft, Inc. | 1998-11-13 |
| BLOWER/MISTER (K983135) | Cardiothoracic Systems, Inc. | 1998-11-13 |
| PANAVIA F (K983361) | Kuraray America, Inc. | 1998-11-13 |
| MEDI-TRACE 4103 NEONATAL ELECTRODE (K981964) | Graphic Controls Corp. | 1998-11-13 |
| DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN (K970811) | Pneumocare, Inc. | 1998-11-13 |
| CARDIOBEEPER CB250 (K983582) | Merdian Medical Technologies , Ltd. | 1998-11-13 |
| HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING (K980711) | Zimmer, Inc. | 1998-11-12 |
| CV PERI-GUARD AND VASCU-GUARD (K983602) | Bio-Vascular, Inc. | 1998-11-12 |
| BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (K983185) | Boehringer Mannheim Corp. | 1998-11-12 |
| LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM (K982906) | Walter Lorenz Surgical, Inc. | 1998-11-12 |
| MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM (K983706) | Sofamor Danek USA,Inc. | 1998-11-12 |
| STARRYSHINE GAUZE SPONGE (K983450) | T.C. Dental Products, Inc. | 1998-11-12 |
| STRATEGY CORONARY WIRE GUIDE (K983771) | Cook, Inc. | 1998-11-12 |
| SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM (K983517) | Ram Scientific | 1998-11-12 |
| STAR AUTOMATED MULTI-PARAMETRIC ANALYZER (K983460) | American Bioproducts Co. | 1998-11-12 |
| ESPRIT VENTILATOR (K981072) | Respironics, Inc. | 1998-11-12 |
| AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U (K982831) | OraSure Technologies, Inc. | 1998-11-12 |
| SCIMED INFORMER PRESSURE WIRE SYSTEM (K974241) | Scimed Life Systems, Inc. | 1998-11-12 |
| PROFA (K981911) | Duncan Hynd Associates, Ltd. | 1998-11-12 |
| ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 (K983578) | Bio-Rad | 1998-11-12 |
| SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE (K981885) | Sunrise Medical, Inc. | 1998-11-12 |