| QUANTA LITE RUBEOLA (MEASLES) IGG (K971620) | Inova Diagnostics, Inc. | 1997-07-22 |
| CRYO CHECK FACTOR V DEFICIENT PLASMA (K971223) | Precision Biologicals, Inc. | 1997-07-22 |
| CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K971608) | Cordis Corp. | 1997-07-21 |
| TIADAPT ABUTMENT SYSTEM (K971706) | Nobel Biocare Uas, Inc. | 1997-07-21 |
| ANTIBACTERIAL GUTTA PERCHA (K971641) | Dr. Howard Martin, P.A. | 1997-07-21 |
| DINABASE (TM) (K971138) | Sultan Chemists, Inc. | 1997-07-21 |
| VERIDOSE V (FIVE), MODEL NUMBER 37-705 (K964952) | Victoreen, Inc. | 1997-07-21 |
| CAUTERIZATION SMOKE EVACUATOR (K971758) | Applied Medical Technologies | 1997-07-21 |
| UNI-GRAFT K DV (K963790) | Atrium Medical Corp. | 1997-07-21 |
| MOMO DESIGN OR MOMO (K972416) | Momo U.S.A., Inc. | 1997-07-21 |
| CHASE VESSEL CANNULA (K971019) | Chase Medical, Inc. | 1997-07-21 |
| CPROTECTOR 2000 (K960587) | Certified Safety Mfg., Inc. | 1997-07-21 |
| CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM (K970178) | Corpak, Inc. | 1997-07-21 |
| FLEXART V3.5 SOFTWARE (K970573) | Toshiba America Mri, Inc. | 1997-07-21 |
| BUN (LIQUID) REAGENT SET (K972671) | Pointe Scientific, Inc., | 1997-07-20 |
| SHARPLAN CO2 SURGICAL LASER SYSTEM (K971743) | Sharplan Lasers, Inc. | 1997-07-18 |
| CRYO CHECK FACTOR X DEFICIENT PLASMA (K971227) | Precision Biologicals, Inc. | 1997-07-18 |
| REST MATTRESS (K971568) | Rest Mattress | 1997-07-18 |
| ATLAS FRACTURE PROXIMAL HUMERAL NAIL (K971816) | Biomet, Inc. | 1997-07-18 |
| BREATH ACE BREATHFRESHENER (K972131) | Beyond 21st Century, Inc. | 1997-07-18 |
| ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II (K961392) | Sil-Med Corp. | 1997-07-18 |
| CORDIS OPTA 5 PTA BALLOON CATHETER (K971579) | Cordis Corp. | 1997-07-18 |
| DERMALASE (K971459) | Endo Technic Corp. | 1997-07-18 |
| DURALASTIC ANATOMICAL MALAR IMPLANTS (K971479) | Allied Biomedical Corp. | 1997-07-18 |
| AESCULAP JET IRRIGATION SYSTEM (K971310) | Aesculap, Inc. | 1997-07-18 |
| ISOLYSER SDS SHARPS CONTAINER (K970547) | Thantex Specialties, Inc. | 1997-07-18 |
| STERICHEK CHLORINE REAGENT STRIPS (K971598) | Environmental Test Systems, Inc. | 1997-07-18 |
| DURALASTIC ANATOMICAL NASAL IMPLANTS (K971481) | Allied Biomedical Corp. | 1997-07-18 |
| HEMISPHERE CEMENTED CUP (K971581) | Ortho Development Corp. | 1997-07-18 |
| DURALASTIC ANATOMICAL CHIN IMPLANTS (K971478) | Allied Biomedical Corp. | 1997-07-18 |
| CARDIOMAGIC 2000 SOFTWARE (K964036) | Instromedix, Inc. | 1997-07-18 |
| SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (K971783) | Synthes (Usa) | 1997-07-18 |
| CRYO CHECK FACTOR IX DEFICIENT PLASMA (K971226) | Precision Biologicals, Inc. | 1997-07-18 |
| 3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160) (K971446) | 3M Company | 1997-07-18 |
| STERILE AMBULATORY RESERVOIR 60ML/100ML (K962159) | Faulding Medical Device Co. | 1997-07-18 |
| PULSE*SPRAY INJECTOR (K963574) | AngioDynamics, Inc. | 1997-07-18 |
| MODIFIED PEDIKAIR (K954320) | Kinetic Concepts, Inc. | 1997-07-18 |
| EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES (K961719) | Howmedica Leibinger, Inc. | 1997-07-17 |
| AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K972297) | Trace America, Inc. | 1997-07-17 |
| CRYO CHECK FACTOR VIII DEFICIENT PLASMA (K971225) | Precision Biologicals, Inc. | 1997-07-17 |
| SOMNOPLASTY SYSTEM (K971450) | Somnus Medical Technologies, Inc. | 1997-07-17 |
| HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM (K971755) | Howmedica Corp. | 1997-07-17 |
| P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) (K971189) | Johnson & Johnson Professionals, Inc. | 1997-07-17 |
| CRYO CHECK FACTOR VII DEFICIENT PLASMA (K971224) | Precision Biologicals, Inc. | 1997-07-17 |
| CREATINE KINASE (CK) (K972155) | Stanbio Laboratory | 1997-07-17 |
| CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER (K971418) | Chiron Diagnostics Corp. | 1997-07-17 |
| PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE) (K965123) | Burke, Inc. | 1997-07-17 |
| MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) (K970471) | Mentor Corp. | 1997-07-17 |
| SCT 3000 HEATED HUMIDIFIER (K970478) | Marquest Medical Products, Inc. | 1997-07-16 |
| DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE (K971741) | Howmedica Corp. | 1997-07-16 |
| OSTEONICS ANTEVERTED NECK HIP STEM (K971497) | Osteonics Corp. | 1997-07-16 |
| COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 (K964821) | Ventrex, Inc. | 1997-07-16 |
| OLYMPUS OES OTV-S5C VIDEO SYSTEM (K971416) | Olympus America, Inc. | 1997-07-16 |
| SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) (K971461) | Fisher & Paykel Electronics , Ltd. | 1997-07-16 |
| ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,) (K972027) | Zhermack S.P.A. | 1997-07-16 |
| ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS (K971414) | Smith & Nephew, Inc., Orthopaedic Div. | 1997-07-16 |
| P.F.C. SIGMA INSET PATELLA (K971652) | Johnson & Johnson Professionals, Inc. | 1997-07-16 |
| OXIMETER PRE-AMP CABLE (K965172) | Epic Medical Equipment Services, Inc. | 1997-07-16 |
| NEEDLE-FREE VALVED CONNECTOR AND CAP (K964439) | Bmw Medical, Inc. | 1997-07-16 |
| BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED (K971457) | Arcan Orthopaedic Corp. | 1997-07-16 |
| ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE (K971168) | Baxter Healthcare Corp | 1997-07-15 |
| NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES (K971355) | Nihon Kohden America, Inc. | 1997-07-15 |
| LL BI-FOCAL, DAILY WEAR CONTACT LENS (K971647) | Lombart Lenses, Ltd. | 1997-07-15 |
| VIDEO EYE TRAKKER (K964646) | Micromedical Technologies, Inc. | 1997-07-15 |
| BIVALVE NASAL SPLINT (K972096) | Boston Medical Products, Inc. | 1997-07-15 |
| MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE (K965068) | Toshiba America Medical Systems, In.C | 1997-07-15 |
| VISUALEYES: VIDEO EYE MONITOR (K964325) | Micromedical Technologies, Inc. | 1997-07-15 |
| ZENTIH FLOWABLE COMPOSITE (MULTIPLE) (K970683) | Foremost Dental Mfg., Inc. | 1997-07-15 |
| SMILE WITH CONFIDENCE (K971002) | Lloyd V. Ziemendorf | 1997-07-15 |
| UNIJECT SURGICAL GLOVES (K970160) | Uniject Gloves , Ltd. | 1997-07-15 |
| CONFOCAL MICROSCOPE (K970414) | Con-S , Ltd. | 1997-07-15 |
| 4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER (K971646) | Cordis Corp. | 1997-07-14 |
| MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL (K971474) | Medtronic Vascular | 1997-07-14 |
| N-ASSAY TIA MULTI V-NL (K964299) | Crestat Diagnostics, Inc. | 1997-07-14 |
| N-ASSAY TIA MULTI V-NL (K964301) | Crestat Diagnostics, Inc. | 1997-07-14 |
| ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE (K951459) | Ortho Diagnostic Systems, Inc. | 1997-07-14 |
| LATEX EXAMINATION GLOVES (K970770) | Oon Corp. Resources | 1997-07-14 |
| MENTOR GEMINI HEMOSTATIC ERASER (K971538) | Mentor Ophthalmics, Inc. | 1997-07-14 |
| CHROMOPHARE (K965130) | Berchtold Holding GmbH | 1997-07-14 |
| CYNOSURE PHOTOGENICA VLV CUTANEOUS VASCULAR LESION LASER (K965128) | Cynosure, Inc. | 1997-07-14 |
| MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR (K970763) | Medical Data Electronics | 1997-07-14 |
| MRI NEEDLES (K963565) | Cook, Inc. | 1997-07-14 |
| COBE CENTURY PERFUSION PUMP (K960974) | Cobe Cardiovascular, Inc. | 1997-07-14 |
| CREATINE KINASE-MB REAGENT SET (K971566) | Horizon Diagnostics, Inc. | 1997-07-14 |
| QUIKSTRIP ONE STEP COCAINE TEST (K971926) | Drial Consultants, Inc. | 1997-07-14 |
| AUTOMATED CHAMBER MAINTENANCE MODULE (K971795) | Paradigm Medical Industries, Inc. | 1997-07-14 |
| ETEST FOR LEVOFLOXACIN (K971697) | Ab Biodisk | 1997-07-14 |
| DTX-100 BONE DENSITOMETER (K963789) | Osteometer Meditech A/S | 1997-07-14 |
| N-ASSAY TIA MULTI V-NL (K964298) | Crestat Diagnostics, Inc. | 1997-07-14 |
| GANTEX MODEL NSG-75PF (K962539) | American Pro Latex, Inc. | 1997-07-14 |
| NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) (K963208) | Neurotron Medical | 1997-07-14 |
| GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE (K971395) | Target Therapeutics | 1997-07-14 |
| N-ASSAY TIA C4 TEST KIT (K964297) | Crestat Diagnostics, Inc. | 1997-07-14 |
| SNT STEREOTACTIC LOCALIZATION SYSTEM (K971675) | Surgical Navigation Technologies, Inc. | 1997-07-14 |
| FOVS, BRILLARTE, ETC... (K972362) | Sunglass City, Inc. | 1997-07-14 |
| ACS DIGITOXIN (K970546) | Chiron Diagnostics Corp. | 1997-07-14 |
| FACTOR DEFICIENT PLASMAS - FACTOR IX (9) (K972288) | Universal Reagents, Inc. | 1997-07-14 |
| N-ASSAY TIA MULTI V-NL (K964300) | Crestat Diagnostics, Inc. | 1997-07-14 |
| PROVEST-PROTECTIVE RESTRAINT (K971561) | Jemm Medical Products | 1997-07-14 |
| ECHOVACS (K971776) | Vmi Technologies | 1997-07-14 |