| DURACON INSET PATELLA, 25MM (K993692) | Howmedica Osteonics Corp. | 1999-12-02 |
| ETHYL CHLORIDE DISPENSER (K984564) | Dukal Corp. | 1999-12-02 |
| MS-30 FEMORAL STEM (K993043) | Sulzer Orthopedics, Inc. | 1999-12-02 |
| STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR (K993104) | Nova Biomedical Corp. | 1999-12-02 |
| RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE (K993944) | Rita Medical Systems | 1999-12-02 |
| DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE (K993215) | Wrp Specialty Products Sdn. Bhd. | 1999-12-02 |
| DRIED GRAM-POSITIVE MIC/COMBO PANELS (K993102) | Dade Microscan, Inc. | 1999-12-02 |
| POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] (K993457) | Sri Johani Sdn. Bhd. | 1999-12-02 |
| CLEARVIEW EASY HCG PREGNANCY TEST (K993703) | Unipath , Ltd. | 1999-12-02 |
| HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A (K992977) | Hewlett-Packard Co. | 1999-12-01 |
| IMPLANTABLE CLIP FOR GENERAL SURGERY (K993135) | Applied Medical Resources | 1999-12-01 |
| DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181 (K993890) | Nihon Seimitsu Sokki Co., Ltd. | 1999-12-01 |
| CPAP/PRO CPAP INTERFACE (K992384) | Stevenson Industries, Inc. | 1999-12-01 |
| ACON ONE STEP PREGNANCY TEST STRIP (URINE) (K993203) | ACON Laboratories, Inc. | 1999-12-01 |
| ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) (K993317) | ACON Laboratories, Inc. | 1999-12-01 |
| ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K974503) | Roche Molecular Systems, Inc. | 1999-12-01 |
| ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F (K993388) | Pharmacia & Upjohn Co. | 1999-12-01 |
| APR METASUL ACETABULAR INSERT (K993569) | Sulzermedica | 1999-12-01 |
| PLATELETWORKS (K990398) | Array Medical, Inc. | 1999-12-01 |
| CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC (K993577) | Becton Dickinson Microbiology Systems | 1999-12-01 |
| K-ASSAY IGM (K993323) | Kamiya Biomedical Co. | 1999-11-30 |
| TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 (K993546) | Medical Analysis Systems, Inc. | 1999-11-30 |
| RETIC-QUINOX (K993496) | Hematronix, Inc. | 1999-11-30 |
| ELECSYS PARATHYROID HORMONE CALCHECK (K993642) | Roche Diagnostics Corp. | 1999-11-30 |
| APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH (K993310) | Dade Behring, Inc. | 1999-11-30 |
| APEX LOCATOR BINGO-1020 (K992233) | Dent Corp. Research & Development | 1999-11-30 |
| K-ASSAY TRANSFERRIN (K993537) | Kamiya Biomedical Co. | 1999-11-30 |
| CKHEMO, MODEL CKHEMO VERSION 1.0 (K992255) | Csam, Inc. | 1999-11-30 |
| PARA TECH PLUS RETICS (K993825) | Streck Laboratories, Inc. | 1999-11-30 |
| SURE BOND (K993013) | Miradent Distributing Co., LLC | 1999-11-29 |
| HYBRID CAPTURE II GC-ID (K981485) | Digene Corp. | 1999-11-29 |
| SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K992862) | Shijiazhuang Great Vision Plastic Products Co., LT | 1999-11-29 |
| MAC-LAB SYSTEM (K992948) | General Electric Medical Systems Information Techn | 1999-11-29 |
| UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES (K993721) | Laborie Medical Tech Corp. | 1999-11-29 |
| K-ASSAY C4 (K993481) | Kamiya Biomedical Co. | 1999-11-29 |
| OPC LOW WEAR OPAQUE PORCELAIN (K993249) | Jeneric/Pentron, Inc. | 1999-11-29 |
| S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K993646) | Cordis Corp. | 1999-11-28 |
| ECG ELECTRODE (VARIOUS) (K991105) | Conmedcorp | 1999-11-26 |
| SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC (K991850) | Biosafe Laboratories, Inc. | 1999-11-26 |
| KAC-300 KNEE ARRAY COIL (K993719) | Mri Devices Corp. | 1999-11-26 |
| CD-CHEX CD 34 (K993126) | Streck Laboratories, Inc. | 1999-11-26 |
| DASH 3000 PATIENT MONITOR (K992929) | General Electric Medical Systems Information Techn | 1999-11-26 |
| PRIMUS (K993425) | Siemens Medical Solutions USA, Inc. | 1999-11-26 |
| NASAL AIRE (K990659) | Breathing Technologies Corp. | 1999-11-26 |
| QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV) (K993765) | Medis Medical Imaging Systems BV | 1999-11-26 |
| MAMEX (K993740) | Medical Systems Group | 1999-11-26 |
| CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 (K992965) | Cordis Webster, Inc. | 1999-11-26 |
| SYNEFLASH & SYNEVIEW (K990727) | Ela Medical, Inc. | 1999-11-26 |
| VARELISA RNP ANTIBODIES (K993589) | Pharmacia & Upjohn Co. | 1999-11-26 |
| QSC-300 SHOULDER ARRAY COILS (K993780) | Mri Devices Corp. | 1999-11-26 |
| HICHEM ISE ELECTROLYTE REFERENCE (K992842) | Elan Holdings, Inc. | 1999-11-26 |
| SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS (K993023) | Beckman Coulter, Inc. | 1999-11-26 |
| MODIFICATION TO DOCUMENT THYROID CAL.VER (K993014) | Casco-Nerl Diagnostics Corporation (Maine) | 1999-11-26 |
| MEDRAD ENVISION CT INJECTOR SYSTEM (K993728) | Medrad, Inc. | 1999-11-26 |
| SYNCHRON SYSTEMS DRUG CALIBRATOR 2 (K993473) | Beckman Coulter, Inc. | 1999-11-26 |
| TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION (K981914) | The Binding Site, Ltd. | 1999-11-26 |
| PBN DILATORS (K990808) | Medical Device Technologies, Inc. | 1999-11-26 |
| HICHEM ISE ELECTROLYTE BUFFER (K992844) | Elan Holdings, Inc. | 1999-11-26 |
| MACRA LP(A) ENZYME IMMUNOASSAY KIT (K992665) | Trinity Biotech USA | 1999-11-26 |
| QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) (K993763) | Medis Medical Imaging Systems BV | 1999-11-26 |
| K-ASSAY APO A1/B CALIBRATOR SET (K993606) | Kamiya Biomedical Co. | 1999-11-26 |
| DIGITRAKPLUS HOLTER RECORDER (K993617) | Braemar Corp. | 1999-11-24 |
| NEW MULTIPLES REAGENT STRIPS (K992257) | Bayer Corp. | 1999-11-24 |
| MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 (K992894) | Baxter Healthcare Corp | 1999-11-24 |
| K-ASSAY HAPTOGLOBIN (K993480) | Kamiya Biomedical Co. | 1999-11-24 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER (K993648) | Boston Scientific Corporation Northwest Technology | 1999-11-24 |
| CT PERFUSION OPTION (K993791) | Ge Medical Systems, Inc. | 1999-11-24 |
| K-ASSAY C3 (K993437) | Kamiya Biomedical Co. | 1999-11-24 |
| PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA (K993360) | Roche Diagnostics Corp. | 1999-11-24 |
| SMART VESSEL ANALYSIS (SMART VA) OPTION (K993792) | Ge Medical Systems, Inc. | 1999-11-24 |
| MODUS 2.5 MANDIBULAR TRAUMA SET (K992683) | Medartis AG | 1999-11-24 |
| ENABLE ENDOSCOPIC BIPOLAR SCISSORS (K992996) | Enable Medical Corp. | 1999-11-24 |
| PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840 (K993071) | Puritan Bennett Corp. | 1999-11-24 |
| POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS) (K993495) | Besglove Medicare Sdn. Bhd. | 1999-11-24 |
| POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS) (K993502) | Besglove Medicare Sdn. Bhd. | 1999-11-24 |
| BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II (K992872) | Entific Medical Systems, Inc. | 1999-11-24 |
| OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS (K992264) | Ocular Sciences Puerto Rico, Inc. | 1999-11-24 |
| ABL 735 ANALYZER (K991417) | Radiometer America, Inc. | 1999-11-24 |
| K-ASSAY ALPHA-1 AT (K993444) | Kamiya Biomedical Co. | 1999-11-24 |
| K-ASSAY ALPHA-1 AG (K993441) | Kamiya Biomedical Co. | 1999-11-24 |
| ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK (K992710) | Abbott Laboratories | 1999-11-24 |
| IGA MININEPH ANTISERUM (K981786) | The Binding Site, Ltd. | 1999-11-24 |
| AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA (K992449) | Cogent Diagnotics , Ltd. | 1999-11-24 |
| N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS (K993637) | Nellcor Puritan Bennett, Inc. | 1999-11-24 |
| METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP (K993252) | CooperVision, Inc. | 1999-11-24 |
| PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA (K992900) | Roche Diagnostics Corp. | 1999-11-24 |
| DXP1000 HOLTER RECORDER (K993618) | Braemar Corp. | 1999-11-24 |
| GEM PREMIER 3000 (K992834) | Instrumentation Laboratory CO | 1999-11-24 |
| HYTAC (K992909) | Espe Dental AG | 1999-11-24 |
| MODUS 2.5 MANDIBULAR RECONSTRUCTION SET (K992682) | Medartis AG | 1999-11-24 |
| AMORPHOUS DIAMOND COATED SCREW (K992538) | Nobel Biocare Uas, Inc. | 1999-11-23 |
| TRENDCARE CALIBRATOR MODEL SCU 7007 (K983198) | Diametrics Medical, Ltd. | 1999-11-23 |
| HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] (K993128) | Health Hero Network, Inc. | 1999-11-23 |
| ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS (K992235) | Corin USA | 1999-11-23 |
| CIDEX OPA SOLUTION TEST STRIP (K992341) | Serim Research Corp. | 1999-11-23 |
| BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS. (K993722) | Hartalega Sdn Bhd | 1999-11-23 |
| THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (K992330) | Biomedics | 1999-11-23 |
| GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS (K993725) | Hartalega Sdn Bhd | 1999-11-23 |
| ROCHE COBAS INTEGRA OPIATES 300/2000 (K992890) | Roche Diagnostics Corp. | 1999-11-23 |
| COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE (K993313) | Wrp Asia Pacific Sdn. Bhd. | 1999-11-23 |