| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K972355 |
08/29/1997 |
3M AURORA SYSTEM |
3M COMPANY |
LISA A WEIK |
| K972245 |
08/06/1997 |
TOM CAT F.L., TOM CAT S.L. |
A & A MEDICAL, INC. |
|
| K972532 |
08/15/1997 |
AALBA GOLD SOLDER |
AALBA DENT, INC. |
VINCENT M BENETTI |
| K972632 |
08/15/1997 |
VERA PD SOLDER |
AALBA DENT, INC. |
VINCENT M BENETTI |
| K972118 |
08/15/1997 |
VERA PDN |
AALBA DENT, INC. |
ROBERT W BAUER |
| K972182 |
08/13/1997 |
ABBOTT STREP A CONTROLS |
ABBOTT DIAGNOSTICS |
GRACE LEMIEUX |
| K971152 |
08/12/1997 |
ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) |
ABBOTT LABORATORIES |
SHERRY HAIFLICH |
| K972838 |
08/15/1997 |
POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED) |
ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD. |
WOLFE BIRKIE |
| K972756 |
08/01/1997 |
MODIFICATION OF EST CULTURE SYSTEM II - MYCO |
ACCUMED INTL., INC. |
CYNTHIA C KNAPP |
| K964689 |
08/18/1997 |
TRACCELL 2000 SLIDE MAPPING SYSTEM |
ACCUMED INTL., INC. |
JOHN MIERS |
| K972183 |
08/26/1997 |
DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL |
ACE MEDICAL CO. |
KATHLEEN A DRAGOVICH |
| K971878 |
08/08/1997 |
VANTAGE 2.1 EXSPECT |
ADAC LABORATORIES |
DENNIS W HENKELMAN |
| K970669 |
08/01/1997 |
AEROQUIP SAFESTART IV CATHETER |
AEROQUIP MEDICAL PRODUCTS |
CHRISTINA L THOMAS |
| K971828 |
08/12/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K972086 |
08/12/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K971827 |
08/12/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K971183 |
08/08/1997 |
GOLD FINGERS |
ALLIANCE RUBBER PRODUCTS SDN. BHD. |
CHUA HOOI KOON |
| K972465 |
08/15/1997 |
ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
PAUL D SMOLENSKI |
| K971519 |
08/19/1997 |
ASSERACHROM TPA TEST KIT |
AMERICAN BIOPRODUCTS CO. |
ANDREW LOC B LE |
| K971540 |
08/14/1997 |
AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD |
AMERICAN BIOSURGICAL, INC. |
MICHAEL SOCOLOFF |
| K971853 |
08/06/1997 |
ENDOVIEW SPPHIRE LENS SET |
AMERICAN MEDICAL DEVICES, INC. |
FRANK J TIGHE |
| K972091 |
08/29/1997 |
AMS FOREIGN BODY EXTRATOR |
AMERICAN MEDICAL SYSTEMS, INC. |
LISA L PRITCHARD |
| K971918 |
08/12/1997 |
AMERIGEL OINTMENT SATURATED WOUND DRESSING |
AMERX HEALTH CARE CORP. |
RON MADDIX |
| K971747 |
08/05/1997 |
AMPLAID 460 |
AMPLIFON S.P.A. |
DANIEL KAMM |
| K971929 |
08/06/1997 |
AMSINO URINARY LEG BAG |
AMSINO INTL., INC. |
RICHARD Y LI |
| K962777 |
08/06/1997 |
AMR MINI-LAPAROSCOPE |
APPLIED MEDICAL RESOURCES |
HOWARD V ROWE |
| K972966 |
08/21/1997 |
AXT 150M MANUAL COLLIMATOR (AXT 150M) |
APPLIED X-RAY TECHNOLOGIES, INC. |
HOWARD C THOMAS |
| K971830 |
08/14/1997 |
ACCU-PULSE CARBON DIOXIDE LASER SYSTEM |
ARGUS PHOTONICS GROUP |
KEVIN DICKENSON |
| K970769 |
08/28/1997 |
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR |
ARISTO MEDICAL |
LARRY LEPLEY |
| K962577 |
08/21/1997 |
ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K973063 |
08/26/1997 |
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR |
ASPECT VISION CARE, LTD. |
MARTIN S KNOPF |
| K972938 |
08/25/1997 |
AURECAST 10 |
AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD |
J.D. DAVIS |
| K972936 |
08/25/1997 |
AURECAST 2 |
AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD |
J.D. DAVIS |
| K972937 |
08/25/1997 |
AURECAST 4 |
AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD |
J.D. DAVIS |
| K972941 |
08/28/1997 |
AURECAST 74 |
AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD |
J.D. DAVIS |
| K972942 |
08/28/1997 |
AURECAST 83 |
AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD |
J.D. DAVIS |
| K972939 |
08/26/1997 |
AURECAST BIO 59PF |
AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD |
J.D. DAVIS |
| K972940 |
08/26/1997 |
AURECAST BIO 69PF |
AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD |
J.D. DAVIS |
| K972319 |
08/26/1997 |
AURECAST GF |
AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD |
J D DAVIS |
| K964017 |
08/05/1997 |
AFFINITY BLOOD PUMP SYSTEM |
AVECOR CARDIOVASCULAR, INC. |
DENNIS E STEGER |
| K971645 |
08/01/1997 |
REGANES SPINAL NEEDLE (VARIOUS) |
AVID N.I.T., INC. |
JOSEPH E HARMS |
| K972673 |
08/20/1997 |
AVL 9181 ELECTROLYTE ANALYZER |
AVL SCIENTIFIC CORP. |
RANDY BYRD |
| K970943 |
08/18/1997 |
GUIDELINE SYSTEM |
AXON INSTRUMENTS, INC. |
ANDREW L BLATZ |
| K970926 |
08/01/1997 |
DOUBLE LUMEN PICC |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K972454 |
08/08/1997 |
OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
DENNIS HAHN |
| K971998 |
08/29/1997 |
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM |
BAYER CORP. |
GABRIEL J MURACA |
| K971958 |
08/20/1997 |
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT |
BECKMAN INSTRUMENTS, INC. |
LUCINDA STOCKERT |
| K972819 |
08/13/1997 |
VIGIL TDM CONTROLS |
BECKMAN INSTRUMENTS, INC. |
LUCINDA STOCKERT |
| K970836 |
08/26/1997 |
TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
ANNA LONGWELL |
| K972758 |
08/08/1997 |
BACTEC MYCO/F-SPUTA CULTURE VIALS |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
COLLEEN ROHRBECK |
| K972469 |
08/27/1997 |
SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE |
BEECH MEDICAL PRODUCTS, INC. |
JOHN ROMANO |
| K971852 |
08/15/1997 |
AIR CONDUCTION HAEARING AIDS |
BELTONE ELECTRONICS CORP. |
ROBERT A KRATOCHVIL |
| K972299 |
08/27/1997 |
BERGEN MODEL 500 ELECTROSURGERY GENERATOR |
BERGEN MFG. |
ROGER OOSTEN |
| K971629 |
08/06/1997 |
PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K972029 |
08/18/1997 |
BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM |
BICON, INC. |
VINCENT MORGAN |
| K972609 |
08/06/1997 |
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM |
BIO-RAD |
JOHN W NELSON |
| K972167 |
08/04/1997 |
PLASMA CATECHOLAMINE KIT |
BIOANALYTICAL SYSTEMS, INC. |
STEPHEN GEARY |
| K972403 |
08/29/1997 |
BTI CORTICAL BONE SCREWS |
BIODYNAMIC TECHNOLOGIES, INC. |
DANNY HODGEMAN |
| K971500 |
08/18/1997 |
ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER |
BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES |
JAMES P KULLA |
| K971870 |
08/19/1997 |
LACTOSORB TRAUMA PLATING SYSTEM |
BIOMET, INC. |
MARY VERSTYNEN |
| K971890 |
08/07/1997 |
RECOVERY PROTRUSIO CAGE |
BIOMET, INC. |
DEBORAH M MATARAZZO |
| K971938 |
08/25/1997 |
REPICCI II UNICONDYLAR KNEE |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K964431 |
08/11/1997 |
ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) |
BIOMET, INC. |
PATRICIA S BERES |
| K972384 |
08/06/1997 |
AQ ONE STEP COCAINE TEST |
BIONIKE LABORATORIES, INC. |
JANIS FREESTONE |
| K972868 |
08/28/1997 |
TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL |
BIONOSTICS, INC. |
BRUCE R WILLIAMS |
| K970145 |
08/11/1997 |
PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) |
BIOSEARCH MEDICAL PRODUCTS, INC. |
MARTIN DYCK |
| K970388 |
08/14/1997 |
A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE |
BIOTRONIK, INC. |
Joseph J Schwoebel |
| K971930 |
08/14/1997 |
BK-N SEALING CAP |
BIOTRONIK, INC. |
KENNETH JENSEN |
| K972129 |
08/12/1997 |
CHLAMYDIATROL AG |
BLACKHAWK BIOSYSTEMS, INC. |
CAROLE POLITO |
| K972235 |
08/12/1997 |
PRECICONTROL TUMOR MARKER 1 AND 2 |
BOEHRINGER MANNHEIM CORP. |
LEEANN CHAMBERS |
| K972048 |
08/12/1997 |
ACCURUN 117 HBEAG POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K972307 |
08/07/1997 |
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K971406 |
08/07/1997 |
ACCURUN 120 HAV IGG POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K971657 |
08/12/1997 |
ACCURUN 121 HAV IGM POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K972884 |
08/22/1997 |
ACCURUN 146 CMV IGM POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K972459 |
08/04/1997 |
RHINOCELL NASAL PACKINGS |
BOSTON MEDICAL PRODUCTS, INC. |
STUART K MONTGOMERY |
| K971673 |
08/05/1997 |
40 CC SUMO |
BOSTON SCIENTIFIC CORP. |
LEO BASTA |
| K971906 |
08/20/1997 |
JEJENOSTOMY FEEDING TUBE |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
| K970296 |
08/29/1997 |
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER |
BOSTON SCIENTIFIC CORP. |
DIANE JOHNSON |
| K972350 |
08/21/1997 |
MODEL 50 BIPOLAR COAGULATOR |
BOSTON SURGICAL PRODUCTS, INC. |
CHARLES VASSALLO |
| K971941 |
08/14/1997 |
AQUA SPRAY |
BOYD INDUSTRIES, INC. |
BRUCE V LIVINGSTON |
| K972371 |
08/19/1997 |
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR |
BRASAMERICA MEDICAL EQUIPMENT, INC. |
SUSAN D GOLDSTEIN-FALK |
| K970927 |
08/26/1997 |
BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM |
BRUNO INDEPENDENT LIVING AIDS, INC. |
WILLIAM W BELSON III |
| K972503 |
08/26/1997 |
CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE |
CALIFORNIA MEDICAL LABORATORIES, INC. |
MEHMET BICAKCI |
| K965066 |
08/11/1997 |
ARRHYTHMIA MAPPING SYSTEM (8100/8300) |
CARDIAC PATHWAYS CORP. |
EARLE L CANTY |
| K965140 |
08/18/1997 |
CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM |
CARDIOMETRICS, INC. |
ERIN DIGNAN |
| K965124 |
08/14/1997 |
LASETTE |
CELL ROBOTICS, INC. |
CONNIE WHITE |
| K972665 |
08/22/1997 |
CHASE BLOOD VESSEL SHUNT |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K971021 |
08/12/1997 |
CHASE PHRENIC NERVE PAD |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K970695 |
08/08/1997 |
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) |
CHIRON DIAGNOSTICS CORP. |
DIANE C OATES |
| K964594 |
08/15/1997 |
VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG) |
CIRCON CORP. |
ERVIN F TAYLOR, P.E. |
| K971026 |
08/14/1997 |
THE CIRCULATOR BOOT |
CIRCULATOR BOOT CORP. |
RICHARD S DILLON |
| K964831 |
08/08/1997 |
SURESCAN |
CLINICON CORP. |
ALAN BUNTING |
| K971881 |
08/12/1997 |
COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS |
COMEG ENDOSCOPY |
KAELYN HADLEY |
| K964229 |
08/19/1997 |
REGULUS NAVIGATOR |
COMPASS INTL., INC. |
DEBRAH A FISHER |
| K972628 |
08/27/1997 |
THERMOGARD & THERMOGARD PLUS ABC |
CONMED CORP. |
IRA D DUESLER |
| K971903 |
08/21/1997 |
SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER |
CONTINUUM BIOMEDICAL, INC. |
ROBERT S ANDERSON |
| K971879 |
08/14/1997 |
SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER |
CONTINUUM BIOMEDICAL, INC. |
ROBERT S ANDERSON |
| K972062 |
08/14/1997 |
CONVATEC NON-ADHESIVE DRESSING |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
ADRIENNE MCNALLY |
| K962167 |
08/29/1997 |
BRONCHIAL BLOCKER |
COOK, INC. |
APRIL LAVENDER |
| K971837 |
08/06/1997 |
VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820 |
COOPERSURGICAL, INC. |
DEBRA A PEKAR |
| K972449 |
08/20/1997 |
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL |
COPAN ITALIA SPA |
CYNTHIA A SINCLAIR |
| K972448 |
08/20/1997 |
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL |
COPAN ITALIA SPA |
CYNTHIA A SINCLAIR |
| K965237 |
08/27/1997 |
NURSES BOUFFANT CAP |
COPIOUMED INTL., INC. |
JANNA P TUCKER |
| K971316 |
08/27/1997 |
POLY (VINYL) EXAM GLOVE, POWDERED |
COPIOUMED INTL., INC. |
JANNA P TUCKER |
| K972110 |
08/14/1997 |
Cordis Endeavor Infusion Catheter |
CORDIS CORP. |
ARIEL MACTAVISH |
| K964292 |
08/01/1997 |
N-ASSAY TIA APO A1 TEST KIT |
CRESTAT DIAGNOSTICS, INC. |
|
| K964294 |
08/01/1997 |
N-ASSAY TIA APO A1/B MULTI CALIBRATOR |
CRESTAT DIAGNOSTICS, INC. |
|
| K964296 |
08/01/1997 |
N-ASSAY TIA APO B TEST KIT |
CRESTAT DIAGNOSTICS, INC. |
|
| K972428 |
08/25/1997 |
EXTRAWEAR, GENTLEMEN'S CHOICE |
CUSTOM SERVICES INTL., INC. |
LILLIE C THOMAS |
| K972427 |
08/20/1997 |
INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK |
CUSTOM SERVICES INTL., INC. |
LILLIE C THOMAS |
| K972002 |
08/27/1997 |
CYNOSURE DERMATOLOGY LASER COOLING TIP |
CYNOSURE, INC. |
GEORGE CHO |
| K971737 |
08/08/1997 |
CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K972782 |
08/15/1997 |
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY |
DADE INTL., INC. |
CAROLYN K GEORGE |
| K972180 |
08/01/1997 |
DRIED GRAM-NEGATIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
SHAROLYN LENTSCH |
| K970575 |
08/05/1997 |
ELECTRO-LITE ELITE POWERED WHEELCHAIR |
DAMACO |
RON HIGGINBOTHAM |
| K964738 |
08/14/1997 |
ELPHA 2000 CONTI |
DAN MED, INC. |
THOMAS SANDGAARD |
| K971044 |
08/25/1997 |
DASH, SULLIVAN, VITAL GARD |
DASH MEDICAL GLOVES, INC. |
ROBERT J SULLIVAN JR. |
| K972566 |
08/14/1997 |
DEXON VIOLET |
DAVIS & GECK, INC. |
VANADA JOHNSON |
| K971745 |
08/06/1997 |
BARD COMPOSITE PROSTHESIS |
DAVOL, INC., SUB. C.R. BARD, INC. |
JEANNETTE G CLOUTIER |
| K970014 |
08/06/1997 |
TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.) |
DELPHI CONSULTING GROUP |
J. HARVEY KNAUSS |
| K970241 |
08/14/1997 |
DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS |
DEPUY, INC. |
SALLY FOUST |
| K970664 |
08/01/1997 |
GLUCOSE REAGENT |
DERMA MEDIA LAB., INC. |
CHARLES C ALLAIN, PH.D. |
| K971309 |
08/01/1997 |
UREA |
DERMA MEDIA LAB., INC. |
CHARLES C ALLAIN |
| K970660 |
08/12/1997 |
DERMAGRAN WOUND MANAGEMENT SYSTEM |
DERMA SCIENCES, INC. |
KENNETH A PALMER, PH.D. |
| K972152 |
08/15/1997 |
DEVMED STEPPING AND STABILIZING SYSTEM |
DEVMED CORP. |
GREG WIITA |
| K972337 |
08/08/1997 |
DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K972414 |
08/29/1997 |
FRESHCELLS |
DIAGNOSTIC HYBRIDS, INC. |
JAMES L BROWN |
| K970298 |
08/20/1997 |
DM-400 HOLTER ECG CASSETTE RECORDER |
DIAGNOSTIC MONITORING |
RAYMOND COHEN |
| K972095 |
08/22/1997 |
IMMULITE 2000 PSA |
DIAGNOSTIC PRODUCTS CORP. |
ROBERT M DITULLIO |
| K972835 |
08/28/1997 |
50NG/ML COCAINE METABOLITE CALIBRATOR |
DIAGNOSTIC REAGENTS, INC. |
YUH-GENG TSAY |
| K972526 |
08/04/1997 |
METHADONE EIA ASSAY |
DIAGNOSTIC REAGENTS, INC. |
YUH-GENG TSAY |
| K971855 |
08/18/1997 |
POTTY PAL AND FOREVER-DRY |
DIGITAL APPLICATIONS, INC. |
D. LYNN SHEPPARD |
| K970165 |
08/26/1997 |
EVITA 2 DURA |
DRAGER, INC. |
HAROLD KNEUER |
| K972059 |
08/28/1997 |
QUIKPAC II ONE STEP COCAINE TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
| K972405 |
08/08/1997 |
QUIKPAC II ONE STEP OPIATE TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
| K972571 |
08/20/1997 |
QUIKSTRIP ONE STEP OPIATES TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
| K972147 |
08/25/1997 |
PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2) |
DYNAMIC SYSTEMS, INC. |
DAVID R COURT |
| K971948 |
08/06/1997 |
PATIENT RESTRAINT |
E.M. ADAMS CO., INC. |
RICHARD K DONAHUE |
| K971894 |
08/20/1997 |
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM |
EASTMAN KODAK COMPANY |
JUDITH A WALLACE |
| K971973 |
08/25/1997 |
KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER |
EASTMAN KODAK COMPANY |
HERMANN ARNDT |
| K970072 |
08/29/1997 |
OPUS S MODEL 4121 AND 4124 PACEMAKERS |
ELA MEDICAL, INC. |
CATHERINE G GOBLE |
| K971970 |
08/20/1997 |
EBI SPINELINK SYSTEM |
ELECTRO-BIOLOGY, INC. |
JON CAPAROTTA |
| K970990 |
08/25/1997 |
GYREX PRIMA 1TG 1.0T MRI SYSTEM |
ELSCINT MR, INC. |
ELIZABETH F LOWDER |
| K972054 |
08/14/1997 |
INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE |
EMPI |
CAROLYN M STEELE HUSTEN |
| K963290 |
08/06/1997 |
COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM |
ENDOSONICS CORP. |
ADAM SAVAKUS |
| K962548 |
08/05/1997 |
BSM BONE SUBSTITUTE MATERIAL KIT |
ETEX CORP. |
DOSUK D LEE |
| K971738 |
08/07/1997 |
ENDOPATH RESPOSABLE TROCAR SYSTEM |
ETHICON ENDO-SURGERY, INC. |
IVAN S PLACKO |
| K971475 |
08/21/1997 |
SHIELDED SURGICAL TROCAR |
ETHICON ENDO-SURGERY, INC. |
IVAN S PLACKO |
| K963899 |
08/22/1997 |
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) |
EXMOOR PLASTICS LTD. |
BRIAN EAST |
| K972594 |
08/26/1997 |
METALPRIMER II |
GC AMERICA, INC. |
TERRY L JORITZ |
| K972046 |
08/15/1997 |
FULL BODY RESTRAINT SYSTEM |
GILLEN INDUSTRIES |
JOHN GILLEN |
| K971043 |
08/01/1997 |
GOLDEN EAGLE |
GOLDEN TECHNOLOGIES, INC. |
CHRIS MCCONNELL |
| K971050 |
08/01/1997 |
GOLDEN HAWK |
GOLDEN TECHNOLOGIES, INC. |
CHRIS MCCONNELL |
| K964219 |
08/11/1997 |
ZIP CONDOM CATHETER |
GOULTER MEDICAL, INC. |
DAVID W SCHLERF |
| K972970 |
08/27/1997 |
MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE |
GRAPHIC CONTROLS CORP. |
KATHLEEN SELOVER |
| K972142 |
08/25/1997 |
ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING |
GUIDANT CORP. |
WAYNE R HOHMAN |
| K971305 |
08/11/1997 |
FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM |
GYNECARE INNOVATION CENTER |
GEORGE M SAVAGE |
| K963073 |
08/14/1997 |
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET |
HARMAC MEDICAL PRODUCTS, INC. |
JOSEPH M KONIECZNY |
| K963336 |
08/14/1997 |
HARMAC THERMODILUTION CATHETER |
HARMAC MEDICAL PRODUCTS, INC. |
JOSEPH KONIECZNY |
| K971867 |
08/13/1997 |
ALICE 4R SYSTEM |
HEALTHDYNE TECHNOLOGIES, INC. |
TIMOTHY Y COWART |
| K971807 |
08/07/1997 |
IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL |
HEAR-RIGHT, INC. |
CRAIG BLOOMINGBURG |
| K972492 |
08/04/1997 |
BELL PROSTHESIS (PARTIAL) |
HEINZ KURZ |
DAGMAR S MASER |
| K972585 |
08/04/1997 |
AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN |
HEINZ KURZ GMBH MEDIZINTECHNIK |
DAGMAR S MASER |
| K972812 |
08/28/1997 |
RAICHEM PREALBUMIN SPIA |
HEMAGEN DIAGNOSTICS, INC. |
JOSEPH M CALIFANO |
| K972710 |
08/15/1997 |
QUANTIFY(901) |
HEMATRONIX, INC. |
JAMES D LAPICOLA |
| K963481 |
08/11/1997 |
ANODYNE CC |
HEYER AMERICA, INC. |
ED RANSOM |
| K955477 |
08/06/1997 |
HI-TEC CO2 INSUFFLATOR TYPE 1300 |
HI TEC MEDICAL VERTRIEBS-GMBH FUR INNOVATIVE MEDIZ |
ULRICH HENZLER |
| K970636 |
08/26/1997 |
TOTALCARE., MODULAR THERAPY SYSTEM (MTS) |
HILL-ROM, INC. |
JAMES G CARPENTER |
| K972466 |
08/28/1997 |
SODIUM CHLORIDE INHALATION SOLUTION, USP |
HOLOPACK INTERNATIONAL, LP |
JOHN J BARTHE |
| K972467 |
08/28/1997 |
STERILE WATER FOR INHALATION, USP |
HOLOPACK INTERNATIONAL, LP |
JOHN J BARTHE |
| K972108 |
08/12/1997 |
ALTA INTRAMEDULLARY ROD SYSTEM |
HOWMEDICA CORP. |
VIVIAN KELLY |
| K972154 |
08/11/1997 |
COHEN DISTRACTOR |
HOWMEDICA LEIBINGER, INC. |
JOHN F DICHIARA |
| K972166 |
08/11/1997 |
GUERRERO - BELL DISTRACTOR |
HOWMEDICA LEIBINGER, INC. |
JOHN F DICHIARA |
| K972173 |
08/15/1997 |
MEDI-SIS SYRINGE INFUSION SYSTEM |
I-FLOW CORP. |
ROBERT J BARD |
| K972606 |
08/29/1997 |
PREGNACOL PREGNANCY TEST |
IMMUNOSTICS, INC. |
DAVID MYCOCK |
| K972444 |
08/26/1997 |
3I INNOVATIVE IMPLANTS AND COVER SCREWS |
IMPLANT INNOVATIONS, INC. |
WILLIAM G CONETY |
| K971705 |
08/06/1997 |
IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED |
IMPLEX CORP. |
GLENN N BYRD |
| K972240 |
08/26/1997 |
IMTEC BIOBARRIER MEMBRANE |
IMTEC CORP. |
M.K. PATTERSON |
| K963521 |
08/06/1997 |
IMZ TWIN PLUS - CYLINDER |
IMZ, GMBH |
ROBERT J SLOMOFF |
| K963520 |
08/12/1997 |
IMZ TWIN PLUS SCREW |
IMZ, GMBH |
ROBERT J SLOMOFF |
| K971950 |
08/01/1997 |
INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER |
INFINITECH, INC. |
ALAN T BECKMAN |
| K972023 |
08/25/1997 |
SLEEP-IN BONE SCREW SYSTEM |
INFLUENCE, INC. |
PETER A BICK |
| K972356 |
08/26/1997 |
INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER |
INNOVASIVE DEVICES, INC. |
STEPHEN PAGE |
| K971922 |
08/07/1997 |
INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER |
INNOVASIVE DEVICES, INC. |
STEPHEN M PAGE |
| K972861 |
08/19/1997 |
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) |
INSTRUMENTATION LABORATORY CO. |
BETTY J LANE |
| K972363 |
08/15/1997 |
IL TEST IRON |
INSTRUMENTATION LABORATORY CO. |
BETTY J LANE |
| K972141 |
08/25/1997 |
THE YELLOW IRIS URINALYSIS WORKSTATION |
INTL. REMOTE IMAGING SYSTEMS |
FRED H DEINDOERFER |
| K970962 |
08/07/1997 |
JMS AV FISTULA NEEDLE |
JMS CO., LTD. |
T HIROSE |
| K970182 |
08/18/1997 |
DINAMAP COMPACT MONITOR |
JOHNSON & JOHNSON MEDICAL, INC. |
DARLENE T KORAB |
| K971982 |
08/12/1997 |
KARL STORZ MODEL 203020 20 EQUIMAT |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K972497 |
08/27/1997 |
KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MARLENA A PIERCY |
| K971977 |
08/12/1997 |
KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MARLENA ALLEN PIERCY |
| K972504 |
08/11/1997 |
MVM 3.3 MM MICROENDOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K970686 |
08/25/1997 |
ACCUTEMP-PROBE |
KENTEC MEDICAL, INC. |
MATT WILKEN |
| K972409 |
08/28/1997 |
AG CHEMISTRY ANALYZER SYSTEM |
LANDMARK SCIENTIFIC, INC. |
T. WHIT ATHEY |
| K964226 |
08/05/1997 |
MEMORY STAPLE (20 SIZES AVAILABLE) |
LANDOS, INC. |
NORMAN F ESTRIN, PH.D. ROC |
| K972394 |
08/25/1997 |
VISTA ANTIGEN BRUCELLA ABORTUS |
LEE LABORATORIES, INC. |
ROBIN C HART |
| K972396 |
08/25/1997 |
VISTA ANTIGEN BRUCELLA MELITENSIS |
LEE LABORATORIES, INC. |
ROBIN C HART |
| K972392 |
08/25/1997 |
VISTA ANTIGEN SALMONELLA H A |
LEE LABORATORIES, INC. |
ROBIN C HART |
| K972391 |
08/25/1997 |
VISTA ANTIGEN SALMONELLA H B |
LEE LABORATORIES, INC. |
ROBIN C HART |
| K972390 |
08/25/1997 |
VISTA ANTIGEN SALMONELLA H C |
LEE LABORATORIES, INC. |
ROBIN C HART |
| K972389 |
08/25/1997 |
VISTA ANTIGEN SALMONELLA H D |
LEE LABORATORIES, INC. |
ROBIN C HART |
| K972387 |
08/25/1997 |
VISTA ANTIGEN SALMONELLA O GROUP A |
LEE LABORATORIES, INC. |
ROBIN C HART |
| K972386 |
08/25/1997 |
VISTA ANTIGEN SALMONELLA O GROUP B |
LEE LABORATORIES, INC. |
ROBIN C HART |
| K972388 |
08/25/1997 |
VISTA ANTIGEN SALMONELLA O GROUP C |
LEE LABORATORIES, INC. |
ROBIN C HART |
| K972395 |
08/25/1997 |
VISTA ANTIGEN SALMONELLA O GROUP D |
LEE LABORATORIES, INC. |
ROBIN C HART |
| K964571 |
08/08/1997 |
VISION CARDIOPLEGIA DELIVERY SYSTEM |
LIFESTREAM INT'L, INC. |
ROSINA ROBINSON, R.N., RAC |
| K960756 |
08/29/1997 |
LIFETECH CASSETTE |
LIFETECH SYSTEMS, INC. |
JOHN OBERST |
| K972175 |
08/28/1997 |
INFUSASLEEVE IIA (IS-2A) |
LOCALMED, INC. |
EDWIN L EE |
| K972058 |
08/15/1997 |
LORIPRO, LORIPRO II |
LORI MEDICAL LABORATORIES, INC. |
GARY MAAS |
| K971796 |
08/12/1997 |
LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS |
LOUISVILLE LABORATORIES, INC. |
MARY MCNAMARA-CULLINANE |
| K972646 |
08/21/1997 |
AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES |
LUDLOW TECHNICAL PRODUCTS |
PATRICK A MALIA |
| K972053 |
08/08/1997 |
PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM |
LUNAR CORP. |
KENNETH D BURCKER |
| K961050 |
08/01/1997 |
RELIEFBAND TENS UNIT (MODIFICATION) |
MAVEN LABS, INC. |
DANIEL J MANELLI |
| K971859 |
08/18/1997 |
EARCHECK |
MDI INSTRUMENTS, INC. |
SANDRA KIMBALL |
| K972563 |
08/22/1997 |
LIFT MASTER |
MECHANICAL APPLICATION DESIGNS, INC. |
DALVA ALEXANDER |
| K972564 |
08/25/1997 |
TILT MASTER CG SYSTEM (CENTER OF GRAVITY), TILT-N-SPACE-SEAT |
MECHANICAL APPLICATION DESIGNS, INC. |
DALVA ALEXANDER |
| K970401 |
08/01/1997 |
MEDI-DYNE GUIDING CATHETER |
MEDI-DYNE, INC. |
NORMA HALL |
| K971933 |
08/01/1997 |
PORT-NEB |
MEDIC-AID LTD. |
PAUL E DRYDEN |
| K972209 |
08/12/1997 |
SPECTROLYSE HEPARIN (ANTI-IIA) |
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
MICHAEL D BICK |
| K970849 |
08/15/1997 |
ENTERAL NUTRITION 1000 ML/500ML |
MEDICAL INFUSION TECHNOLOGIES, INC. |
JOHN MCNEIRNEY |
| K972117 |
08/26/1997 |
MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW |
MEDICAL SPECIALTY INNOVATIONS, INC. (MSI) |
CAROLANN KOTULA |
| K971499 |
08/28/1997 |
FEMALE EXTERNAL URINARY COLLECTION POUCH |
MEDIQUEST, INC. |
GREG HOLLAND |
| K971812 |
08/08/1997 |
PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP |
MEDISENSE, INC. |
MICHAEL HALPIN |
| K971860 |
08/18/1997 |
MEDISYSTEMS DIALYSIS PRIMING SETS |
MEDISYSTEMS CORP. |
LARRY R PILOT |
| K963668 |
08/15/1997 |
MEDISYSTEMS PERITONEAL DIALYSIS SETS |
MEDISYSTEMS CORP. |
LARRY R PILOT |
| K972308 |
08/20/1997 |
MEDNEXT 1000 DRILL |
MEDNEXT, INC. |
THOMAS J MICKEL |
| K970344 |
08/06/1997 |
MDILOG, MODEL MDC-511 |
MEDTRAK TECHNOLOGIES, INC. |
LINDA NELSON |
| K972107 |
08/15/1997 |
MINIMED INFUSION PUMP, MODEL 507C |
MEDTRONIC MINIMED |
DON SELVEY |
| K972043 |
08/22/1997 |
MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER |
MEDTRONIC VASCULAR |
DAVID H MUELLER |
| K971814 |
08/01/1997 |
IMPROVEMENTS TO THE MEHL RUBY LASER |
MEHL/BIOPHILE INTL., INC. |
THOMAS BLAKE |
| K972443 |
08/22/1997 |
MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS |
MENICON U.S.A., INC. |
CRISTINA M SCHNIDER |
| K971585 |
08/20/1997 |
IMMUNOCARD STAT! ROTAVIRUS |
MERIDIAN DIAGNOSTICS, INC. |
ALLEN D NICKOL |
| K972683 |
08/18/1997 |
V-DELTA 450 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
| K963925 |
08/08/1997 |
THROMBOLYTIC BRUSH CATHETER |
MICRO THERAPEUTICS, INC. |
LINDA D'ABATE |
| K970305 |
08/15/1997 |
PRINTER INTERFACE |
MICROMEDICAL, INC. |
MALCOLM CASTLE |
| K972055 |
08/29/1997 |
MSI MAGNA-STYM |
MICROVAS SYSTEMS, INC. |
LARRY COHEN |
| K972976 |
08/29/1997 |
CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL |
MORE DIAGNOSTICS |
JAMES W SNIPES |
| K942685 |
08/12/1997 |
ECG REVIEW STATION |
MORTARA INSTRUMENT, INC. |
LARRY A LEPLEY |
| K972013 |
08/26/1997 |
NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS |
NATIONAL HEALTHCARE MFG. CORP. |
CAROLANN KOTULA |
| K970436 |
08/15/1997 |
E-READER |
NATURAL HERBAL PRODUCTS, INC. |
|
| K971946 |
08/25/1997 |
NPB-190 PULSE OXIMETER (NPB-190) |
NELLCOR PURITAN BENNETT, INC. |
ROGER D BROWN |
| K972310 |
08/20/1997 |
NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH |
NIHON KOHDEN AMERICA, INC. |
GARY REASONER |
| K962271 |
08/08/1997 |
ELECTROSURGICAL ELECRTRODES |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
| K971509 |
08/21/1997 |
ENDOXANE |
Novatech S.A. |
BRUNO FERREYROL |
| K972039 |
08/25/1997 |
NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) |
NU-SOUND |
WAVA BRIANS |
| K972810 |
08/26/1997 |
OPT80 THE TRANSPORTABLE (OPT80) |
O.P.T. USA, INC. |
MARIA CORIA |
| K964804 |
08/06/1997 |
FLEXILOG LS |
OAKFIELD INSTRUMENTS, LTD. |
JOHN GIDDINGS |
| K972766 |
08/14/1997 |
PIVOTING COMPENSATING FILTERS FOR THE HEAD |
OCTOSTOP, INC. |
JEAN A VENZINA |
| K972303 |
08/20/1997 |
OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS |
OCULAR SCIENCES PUERTO RICO, INC. |
DAVID MARCUS |
| K971117 |
08/22/1997 |
WARMETTE |
OLYMPIC MEDICAL CORP. |
JOSEPH P STEFANILE |
| K970561 |
08/01/1997 |
GRAFT PATCH |
ORGANOGENESIS, INC. |
DIANE E MINEAR, RAC |
| K970611 |
08/19/1997 |
ORIGIN CARDIAC STABLIZER OCCLUDER |
ORIGIN MEDSYSTEMS, INC. |
ANTHONY DURSO |
| K964354 |
08/29/1997 |
ARTOCOOL-S WATER CIRCULATING COLD PACK |
ORMED GMBH |
DAVID W SCHLERF |
| K964799 |
08/29/1997 |
ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY |
ORMED GMBH |
DAVID W SCHLERF |
| K970675 |
08/22/1997 |
HEADLOC CERAMIC HEAD |
ORTHO DEVELOPMENT CORP. |
CAROL J FREASIER |
| K972278 |
08/06/1997 |
CYTOPLAST REGENTEX TITANIUM 250 |
OSTEOGENICS CO. |
RICHARD A HAMER |
| K964562 |
08/22/1997 |
DTX-200 BONE DENSITOMETER |
OSTEOMETER MEDITECH A/S |
BERT HUDSON |
| K972196 |
08/25/1997 |
OSTEO ANATOMICAL BONE PLATES |
OSTEONICS CORP. |
KATE SUTTON |
| K971962 |
08/11/1997 |
OSTEO KIRSCHNER WIRES |
OSTEONICS CORP. |
TERRY SHERIDAN |
| K972331 |
08/01/1997 |
INNOFLUOR GENTAMICIN ASSAY SYSTEM |
OXIS INTL., INC. |
LYNDA M TAYLOR |
| K971964 |
08/15/1997 |
OXLIFE EXCELL OXYGEN CONCENTRATORS |
OXLIFE, INC. |
STUART BASSINE |
| K971638 |
08/20/1997 |
CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K971632 |
08/13/1997 |
TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K972135 |
08/26/1997 |
MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET |
P/L Biomedical |
|
| K972627 |
08/13/1997 |
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056) |
PACIFIC HEMOSTASIS |
LAURA A WORFOLK |
| K972327 |
08/11/1997 |
METAGEN ACTIVELOCK CERCLAGE SYSTEM |
PACIFIC MATERIALS AND INTERFACES |
FLOYD G LARSON |
| K970347 |
08/29/1997 |
MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM |
PALADIN MEDICAL, INC. |
ELAINE DUNCAN |
| K972042 |
08/05/1997 |
PARI PEP THERAPY SYSTEM |
PARI HOLDING CO. |
MIGUEL A ARRIZON |
| K972421 |
08/29/1997 |
EASY BOND |
PARKELL, INC. |
NELSON J GENDUSA |
| K972567 |
08/20/1997 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLION |
| K971951 |
08/15/1997 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K965032 |
08/20/1997 |
THE PERIOSEAL DENTAL IMPLANT |
PERIOSEAL |
DONALD P CALLAN |
| K972577 |
08/20/1997 |
QUICK SCREEN ONE STEP AMPHETAMINE TEST |
PHAMATECH |
CARL MONGIOVI |
| K972618 |
08/08/1997 |
QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070) |
PHAMATECH |
CARL MONGIOVI |
| K972619 |
08/20/1997 |
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) |
PHAMATECH |
CARL MONGIOVI |
| K972682 |
08/01/1997 |
QUICKSTICK ONE STEP HCG PREGNANCY TEST |
PHAMATECH |
|
| K971884 |
08/20/1997 |
ASSET APOLLO |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K972105 |
08/01/1997 |
PHONAK EPICA |
PHONAK, INC. |
LAURA M VOLL |
| K972106 |
08/15/1997 |
PHONAK NOVO FORTE E3 |
PHONAK, INC. |
LAURA M VOLL |
| K970812 |
08/05/1997 |
PM 2002 CC PROLINE |
PLANMECA OY |
LARS MORING |
| K972536 |
08/15/1997 |
SYRINGE NEEDLE REMOVER (S.N.R.) |
POST MEDICAL, INC. |
DAVID R THEAD |
| K971222 |
08/19/1997 |
CRYO CHECK APC RESISTANT PLASMA |
PRECISION BIOLOGICALS, INC. |
STEPHEN L DUFF |
| K971219 |
08/29/1997 |
CRYO CHECK INR VALIDATION SET |
PRECISION BIOLOGICALS, INC. |
STEPHEN L DUFF |
| K970891 |
08/22/1997 |
DRAPE, SURGICAL-LATEX |
PROTEK MEDICAL PRODUCTS, INC. |
RICK L PRUTER |
| K970115 |
08/15/1997 |
POWDER FREE LATEX EXAMINATION GLOVES |
PT MBF BUANA MULTICORPORA |
NG POY SIN |
| K964779 |
08/27/1997 |
MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE |
QUANTUM LOOP, INC. |
THOMAS C WEHMAN |
| K972748 |
08/29/1997 |
CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE |
QUIDEL CORP. |
Robin Weiner |
| K972742 |
08/29/1997 |
QUICKVUE ONE-STEP HCG-URINE |
QUIDEL CORP. |
Robin Weiner |
| K964784 |
08/13/1997 |
SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) |
QUINTON, INC. |
MATTHEW HEDLUND |
| K971397 |
08/25/1997 |
VIEWCATH 3-D CATHETER PULLBACK |
QUINTON, INC. |
ROY A SMITH |
| K961942 |
08/18/1997 |
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI |
RADIONICS, INC. |
AMY J LAFORTE |
| K972608 |
08/04/1997 |
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K970646 |
08/25/1997 |
SAFARI |
RANGER ALL SEASON CORP. |
RON STEWART |
| K971146 |
08/25/1997 |
LAPARETTE |
RD CHUS, INC. |
ROSINA ROBINSON |
| K964444 |
08/11/1997 |
QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM |
RDH MEDICAL |
ROY B HOLLSTIEN |
| K972482 |
08/13/1997 |
REAADS PROTEIN S ANTIGEN TEST KIT |
REAADS MEDICAL PRODUCTS, INC. |
NANCI DEXTER |
| K972005 |
08/13/1997 |
REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT |
REAADS MEDICAL PRODUCTS, INC. |
NANCI DEXTER |
| K971542 |
08/14/1997 |
ORTHO DX NEUROMUSCULAR STIMULATOR |
REHABILICARE, INC. |
GARY L MOORE |
| K972359 |
08/28/1997 |
REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN |
REMEL, L.P. |
MARY ANN SILVIUS |
| K972134 |
08/26/1997 |
BAG DECANTER |
REMINGTON MEDICAL, INC. |
DON ROSVOLD |
| K972122 |
08/29/1997 |
DREAM CATCHER |
REST TECHNOLOGIES, INC. |
RONALD LUICH |
| K971763 |
08/26/1997 |
BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER |
RETRACTABLE TECHNOLOGIES, INC. |
TERANCE GRISSO |
| K970129 |
08/18/1997 |
TULIP |
RICHARD TING |
RICHARD TING |
| K971166 |
08/27/1997 |
OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K970027 |
08/08/1997 |
FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005 |
RMDS, INC. |
DELBERT L RICE |
| K972250 |
08/12/1997 |
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K972721 |
08/06/1997 |
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
JAMES W HAYNES |
| K972717 |
08/25/1997 |
RUFF WORK EYEGEAR |
RUFF HOUSE, INC. |
THOMAS C RUFF |
| K970135 |
08/25/1997 |
NITRILE GLOVES |
SAGE PRODUCTS, INC. |
KAREN PINTO |
| K972279 |
08/29/1997 |
SHARPS SHUTTLE |
SAGE PRODUCTS, INC. |
KAREN PINTO |
| K972035 |
08/29/1997 |
SPOROX TEST STRIPS |
SERIM RESEARCH CORP. |
ROBERT C BOGUSLASKI |
| K971609 |
08/14/1997 |
SCULPTURE |
SERVIZI MEDICO ESTETICI ITALINAI SRL. |
TONIA LATHAM |
| K971874 |
08/18/1997 |
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) |
SHARPLAN LASERS, INC. |
GEORGE J HATTUB |
| K972099 |
08/27/1997 |
SHARPLAN EPITOUCH RUBY LASER SYSTEM |
SHARPLAN LASERS, INC. |
GEORGE J HATTUB |
| K970508 |
08/04/1997 |
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM |
SHIMADZU MEDICAL SYSTEMS |
YASUHARU ISHII |
| K972104 |
08/15/1997 |
LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES |
SHINEMOUND ENTERPRISE, INC. |
HUAN-CHUNG LI |
| K972276 |
08/15/1997 |
CEREC 2 CROWN SOFTWARE |
SIEMENS AG |
STEVEN CLARKE |
| K971684 |
08/05/1997 |
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K970348 |
08/15/1997 |
SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Jacqueline Emery |
| K965207 |
08/21/1997 |
RID-DECUBE II |
SKIN CARE MANAGEMENT, INC. |
ERIC FLAM, PH.D. |
| K971939 |
08/06/1997 |
SMITH & NEPHEW SUTURE COLLET |
SMITH & NEPHEW ENDOSCOPY, INC. |
AMY L WALTERS |
| K970511 |
08/12/1997 |
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES |
SMITH & NEPHEW, INC. |
DEBORAH J CONNORS |
| K971850 |
08/12/1997 |
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES |
SMITH & NEPHEW, INC. |
DEBORAH J CONNORS |
| K970635 |
08/14/1997 |
TITANIUM SPINAL ROD SYSTEM |
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
JOANN KUHNE |
| K964907 |
08/21/1997 |
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT |
SORIN BIOMEDICAL, INC. |
RICHARD J DERISIO |
| K971845 |
08/15/1997 |
HEARTLAND TECHNOLOGIES, ITE, ITC, CIC |
SOUND HEARING INSTRUMENTS, INC. |
DALE WOODARD |
| K965187 |
08/01/1997 |
SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD |
SPARTA SURGICAL CORP. |
THOMAS J BOUCHARD |
| K972233 |
08/05/1997 |
STRYKER WEDGE INTERFERENCE SCREW SYSTEM |
Stryker Endoscopy |
DOUGLAS M LORANG |
| K971715 |
08/07/1997 |
SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS |
SULZER ORTHOPEDICS, INC. |
JACQUELYN HUGHES |
| K972032 |
08/12/1997 |
VISUALINE II METHAMPHETIMINE |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
| K972797 |
08/12/1997 |
TOOL-LESS WHEEL CHAIR |
SUNRISE MEDICAL, INC. |
REBECCA ANDERSEN |
| K971102 |
08/29/1997 |
AMBIDERM |
SUPERTEX INDUSTRIAL, S.A. DE C.V. |
ENRIQUE SALCEDO PADILLA |
| K965221 |
08/07/1997 |
RANSFORD CERVICAL FIXATION SYSTEM |
SURGICRAFT LTD. |
PETER DINES |
| K954758 |
08/18/1997 |
ROOTFORM DENTAL IMPLANT SYSTEM |
SWISS DENTAL CENTER |
LES PHILLIPS |
| K972369 |
08/15/1997 |
SEALAPEX |
SYBRON DENTAL SPECIALTIES, INC. |
WILLIAM R PIKE |
| K972716 |
08/07/1997 |
SYNERMED TOTAL BILIRUBIN REAGENT KIT |
SYNERMED, INC. |
MARCIA J ARENTZ |
| K970048 |
08/01/1997 |
SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS) |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K972508 |
08/26/1997 |
SURGICAL BURS AND SURGICAL DRILL BITS |
SYNVASIVE TECHNOLOGY, INC. |
MICHAEL G FISHER |
| K971736 |
08/26/1997 |
SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER |
SYSMEX CORP. |
CATHERINE M TRESTER |
| K971848 |
08/15/1997 |
TDK MEDICAL GRADE CD-R |
TDK ELECTRONICS CORPORATION OF AMERICA |
KOYO YOKOI |
| K962951 |
08/06/1997 |
MODEL HS-2 TENS DEVICE |
TECHNALITHICS LABORATORIES, INC. |
|
| K964176 |
08/14/1997 |
TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS |
TECNO INSTRUMENTS (USA), INC. |
MICHAEL JANOCIK |
| K971937 |
08/15/1997 |
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE |
TERUMO MEDICAL CORP. |
KRISTINE WAGNER |
| K971953 |
08/14/1997 |
CONFOSCAN |
TOMEY CORPORATION USA |
DAVE MACLELLAN |
| K963451 |
08/05/1997 |
ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING |
TOPSLANE |
ANN ZENG |
| K972586 |
08/29/1997 |
AIA-PACK TSH 3RD-GEN ASSAY |
TOSOH MEDICS, INC. |
LORI ROBINSON |
| K971677 |
08/20/1997 |
ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD |
TRANSAMERICAN TECHNOLOGIES INTL. |
ALLEN R HOWES |
| K964424 |
08/08/1997 |
ROTAVIRUS EIA |
TRINITY BIOTECH, INC. |
GRACE HOLLAND |
| K972160 |
08/01/1997 |
CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST |
TRINITY LABORATORIES, INC. |
BRUCE A CLINTON |
| K972411 |
08/29/1997 |
LINK CEMENT PLUG |
TURNKEY INTERGRATION USA, INC. |
DOUGLAS W STUART |
| K971731 |
08/05/1997 |
UNIGLOVES |
UNI-GLOVE (USA), INC. |
ROBERT D VANDER LEEK |
| K972583 |
08/29/1997 |
URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S |
URESIL CORP. |
LEV MELINYSHYN |
| K971271 |
08/18/1997 |
BESECURE EXTERNAL URINARY COLLECTION SYSTEM |
UROLOGY RESEARCH INTL., INC. |
FRANK A MANFREDI |
| K971992 |
08/01/1997 |
UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) |
UROMED CORP. |
NANCY MACDONALD |
| K972340 |
08/21/1997 |
INSIGHT 7000 PHASED ARRAY TORSO COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K971986 |
08/26/1997 |
VALLEY FORGE BIPOLAR LOOP |
VALLEY FORGE SCIENTIFIC CORP. |
JERRY L MALIS |
| K971839 |
08/15/1997 |
VARIAN RADIATION THERAPY IMAGING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
CHARLES H WILL |
| K965178 |
08/19/1997 |
NIAGARA DUAL LUMEN CATHETER |
VAS-CATH, INC. |
DOLORES MCGIRR |
| K972755 |
08/05/1997 |
V-12 LONG LIFE 675 HEARING AID |
VISTA LABS |
JAMES E PANNETTE |
| K970196 |
08/21/1997 |
T-WALL UNCUFFED TRACHEAL TUBE |
VITAL SIGNS, INC. |
ANTHONY P MARTINO |
| K972115 |
08/29/1997 |
VOLKER HOSPITAL BED, MODEL K960 |
VOLKER HEALTHCARE, INC. |
MILTON N BENEKE |
| K972061 |
08/21/1997 |
TOA |
W. KEITH THORNTON, D.D.S. |
W. KEITH THORNTON |
| K971200 |
08/29/1997 |
W.A. |
W.A. RUBBERMATE CO., LTD. |
JAMES K HOEY |
| K972322 |
08/18/1997 |
LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES |
WALTER LORENZ SURGICAL, INC. |
DIANA PRESTON |
| K972420 |
08/11/1997 |
LORENZ PECTUS SUPPORT BAR |
WALTER LORENZ SURGICAL, INC. |
DIANA PRESTON |
| K971956 |
08/22/1997 |
CRT2000 THERMOGRAPHIC SYSTEM |
WERNER EIDAM MEDIZIN-TECHNOLOGIE GMBH |
EMALEE G MURPHY |
| K964616 |
08/07/1997 |
QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT |
WHITESIDE BIOMECHANICS, INC. |
MICHAEL C WALL, R.N. |
| K972674 |
08/15/1997 |
WILSON-COOK NEEDLE KNIFE PAPILLOTOME |
WILSON-COOK MEDICAL, INC. |
LINDA HENSLEY |
| K972231 |
08/26/1997 |
OSOM MONO TEST 143 |
WYNTEK DIAGNOSTICS, INC. |
SHU-CHING CHENG |
| K965244 |
08/27/1997 |
Z TECH TRANSCUTANEOUS NEURAL STIMULATION |
Z TECHNOLOGIES, LLC |
LES W HORN |
| K971503 |
08/20/1997 |
MYCOPLASMA IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K972239 |
08/01/1997 |
ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING |
ZHERMACK S.P.A. |
EVAN DICK |
