| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K971187 |
05/05/1997 |
STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE |
AARON MEDICAL INDUSTRIES |
J. R SARON |
| K964236 |
05/01/1997 |
(MODIFIED) ETEST PACKAGE INSERT |
AB BIODISK |
ANNE BOLMSTROM |
| K970210 |
05/01/1997 |
AMIKACIN |
AB BIODISK |
ANNE BOLMSTROM |
| K970473 |
05/01/1997 |
ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE |
AB BIODISK |
ANNE BOLMSTROM |
| K965102 |
05/08/1997 |
ACROMED PEDICLE SCREW |
ACROMED CORP. |
WILLIAM CHRISTIANSON |
| K970587 |
05/09/1997 |
AD-TECH SUBDURAL ELECTRODE |
AD-TECH MEDICAL INSTRUMENT CORP. |
CURTIS VAN ALLEN II |
| K964644 |
05/09/1997 |
AD-TECH'S DEPTH ELECTRODE |
AD-TECH MEDICAL INSTRUMENT CORP. |
DAVID A PUTZ |
| K971213 |
05/27/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K971212 |
05/27/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K971237 |
05/27/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K971234 |
05/27/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K971108 |
05/06/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K970799 |
05/14/1997 |
ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) |
ALEXANDER MFG. CO. |
STACEY HIPPEN |
| K970787 |
05/14/1997 |
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3) |
ALEXANDER MFG. CO. |
STACEY HIPPEN |
| K970784 |
05/14/1997 |
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T) |
ALEXANDER MFG. CO. |
STACEY HIPPEN |
| K970786 |
05/27/1997 |
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7) |
ALEXANDER MFG. CO. |
STACEY HIPPEN |
| K970554 |
05/27/1997 |
CONVERTORS SMS DRAPES |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K971480 |
05/28/1997 |
DURALASTIC I AND DURALASTIC II |
ALLIED BIOMEDICAL CORP. |
GERALD HANSON |
| K970673 |
05/05/1997 |
DISPOSABLE VITRECTOMY PROBE |
ALTEX VISION |
LEONARD KASTRILEVICH |
| K970670 |
05/06/1997 |
REUSABLE VITRECTOMY PROBE |
ALTEX VISION |
LEONARD KASTRILEVICH |
| K964922 |
05/21/1997 |
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
THOMAS D KELLY |
| K964584 |
05/15/1997 |
AMBU SPUR NEONATE |
AMBU, INC. |
SANJAY H PARIKH |
| K964718 |
05/23/1997 |
STA D-DI CALIBRATOR KIT |
AMERICAN BIOPRODUCTS CO. |
ANDREW LOC B. LE |
| K970667 |
05/13/1997 |
NUVO-LASE 660 LASER SYSTEM |
AMERICAN LASER MEDICAL |
DANIEL HOEFER |
| K970875 |
05/20/1997 |
ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) |
AMERICAN MEDICAL DEVICES, INC. |
FRANK J TIGHE |
| K970878 |
05/06/1997 |
ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT |
AMERICAN MEDICAL DEVICES, INC. |
FRANK J TIGHE |
| K970873 |
05/20/1997 |
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) |
AMERICAN MEDICAL DEVICES, INC. |
FRANK J TIGHE |
| K970814 |
05/27/1997 |
NON-STERILE ISOLATION GOWN |
AMERICAN SEAL CO. |
JOSEPH TUNG |
| K962807 |
05/02/1997 |
AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES |
AMERICAN SURGICAL SPONGES |
CAROLANN KOTULA |
| K971249 |
05/06/1997 |
GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN |
ANDREW G. HALPERN |
ANDREW G HALPERN |
| K964033 |
05/06/1997 |
3F ANGIOPTIC ANGIOGRAPHIC CATHETER |
ANGIODYNAMICS, INC. |
BRIAN KUNST |
| K964034 |
05/06/1997 |
TRANSJUGULAR ACCESS SET |
ANGIODYNAMICS, INC. |
BRIAN KUNST |
| K970362 |
05/16/1997 |
CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM |
APEX METAL, INC. |
|
| K971498 |
05/05/1997 |
APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE |
APPLIED MEDICAL RESOURCES |
HOWARD V ROWE |
| K970526 |
05/28/1997 |
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP |
ARTHROCARE CORP. |
CHERLY L SHEA |
| K971049 |
05/21/1997 |
FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) |
ASPECT VISION CARE, LTD. |
MARTIN S KNOPF |
| K971164 |
05/21/1997 |
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS |
ASPECT VISION CARE, LTD. |
ANTHONY GALLEY |
| K970951 |
05/19/1997 |
GRASS BRAINWAVE SOFTWARE |
ASTRO-MED, INC. |
STEPHEN E JOHNSON |
| K971100 |
05/23/1997 |
ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR |
ATRION MEDICAL PRODUCTS, INC. |
DAN CLARKE |
| K970522 |
05/14/1997 |
MYERSON'S ECONOMY DENTURE BASE MATERIAL |
AUSTENAL, INC. |
RONALD DUDEK |
| K970426 |
05/09/1997 |
VALUETRODE |
AXELGAARD MFG. CO., LTD. |
DAN JEFFERY |
| K955622 |
05/06/1997 |
AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM; |
BAXTER HEALTHCARE CORP. |
MARCIA MARCONI |
| K955816 |
05/06/1997 |
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR |
BAXTER HEALTHCARE CORP. |
IRENE P PARKER |
| K964791 |
05/29/1997 |
B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) |
BAYER CORP. |
GABRIEL J MURACA, JR. |
| K971534 |
05/21/1997 |
SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL |
BECKMAN |
FRANK MARTE |
| K964781 |
05/09/1997 |
IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT |
BECKMAN INSTRUMENTS, INC. |
FRANK MARTE |
| K970919 |
05/21/1997 |
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT |
BECKMAN INSTRUMENTS, INC. |
SHERI HALL |
| K971333 |
05/23/1997 |
SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD |
BECKMAN INSTRUMENTS, INC. |
LUCINDA STOCKERT |
| K971287 |
05/08/1997 |
SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS |
BECKMAN INSTRUMENTS, INC. |
SHERI HALL |
| K971203 |
05/16/1997 |
SYNCHRON SYSTEMS THYROXINE REAGENT |
BECKMAN INSTRUMENTS, INC. |
LUCINDA STOCKERT |
| K970645 |
05/19/1997 |
BC THROMBIN REAGENT |
BEHRING DIAGNOSTICS, INC. |
PAUL L ROGERS, JR. |
| K970431 |
05/05/1997 |
BEHRING COAGULATION SYSTEM |
BEHRING DIAGNOSTICS, INC. |
PAUL L ROGERS, JR. |
| K964132 |
05/13/1997 |
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K971691 |
05/30/1997 |
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3 |
BIO-RAD |
ELIZABETH PLATT |
| K971048 |
05/09/1997 |
PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT |
BIO-VASCULAR, INC. |
BARBARA ATZENHOEFER |
| K962317 |
05/07/1997 |
MAGNES 2500 WH BIOMAGNETOMETER |
BIOMAGNETIC TECHNOLOGIES, INC. |
EUGENE C HIRSCHKOFF, PH.D. |
| K971515 |
05/20/1997 |
PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK) |
BIOMED DEVICES CORP. |
MARTIN DALSING |
| K962753 |
05/19/1997 |
KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS) |
BIOMEDICAL IMPLANT TECHNOLOGY, INC. |
RONALD MCCARLEY |
| K965092 |
05/05/1997 |
VIDAS ROTAVIRUS ASSAY |
BIOMERIEUX VITEK, INC. |
TERRY MCGOVERN |
| K970703 |
05/19/1997 |
GALILEO HALLEY |
BIOSOUND ESAOTE, INC. |
GERALD A RICHARDSON |
| K964814 |
05/07/1997 |
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER |
BIPORE, INC. |
DURMUS KOCH |
| K970881 |
05/14/1997 |
CEDIA DIGOXIN |
BOEHRINGER MANNHEIM CORP. |
Yvette Lloyd |
| K970883 |
05/21/1997 |
CEDIA DIGOXIN II |
BOEHRINGER MANNHEIM CORP. |
Yvette Lloyd |
| K970379 |
05/01/1997 |
CHANNEL BALLOON CATHETER |
BOSTON SCIENTIFIC CORP. |
MARY P LEGRAW |
| K963254 |
05/21/1997 |
SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
BOSTON SCIENTIFIC CORP. |
LAURA MONDANO |
| K962899 |
05/20/1997 |
ULTRAFLEX DIAMOND |
BOSTON SCIENTIFIC CORP. |
DANIEL J DILLOM |
| K970586 |
05/12/1997 |
BRAINLAB MICRO MULTI-LEAF COLLIMATOR |
BRAINLAB MED. COMPUTERSYSTEME GMBH |
STEFAN VILSMEIER |
| K962939 |
05/22/1997 |
VECTORVISION |
BRAINLAB, INC. |
STEFAN VILSMEIER |
| K964252 |
05/27/1997 |
ORTHOCHUCK |
BUCKMAN CO., INC. |
DAVID W SCHLERF |
| K954577 |
05/09/1997 |
WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS |
C.A.I. INDUSTRIES CORP. |
LU RAO |
| K964861 |
05/29/1997 |
ACUPUNCTURE NEEDLES |
C.A.M. SUPPLY, INC. |
JOHN N POLITIS |
| K963782 |
05/02/1997 |
BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS |
C.R. BARD, INC. |
DONNA J WILSON |
| K971034 |
05/28/1997 |
USCI MAINSTAY GUIDING CATHETER |
C.R. BARD, INC. |
ANNE KULIS |
| K971025 |
05/22/1997 |
AYURVEDIC TONGUE CLEANER |
CALELLO MARTINEZ P.C. |
ANTONIO C MARTINEZ, II |
| K965232 |
05/14/1997 |
CALTAG CAL-LYSE |
CALTAG LABORATORIES, INC. |
DAVID C BISHOP, PH.D. |
| K971148 |
05/15/1997 |
700-SP SERIES DISPOSABLE STIMULATION ELECTRODES |
CARDIOTRONICS SYSTEMS, INC. |
TIM J WAY |
| K971748 |
05/29/1997 |
TAS PT-NCTEST CONTROLS |
CARDIOVASCULAR DIAGNOSTICS, INC. |
James M Clinton |
| K971445 |
05/02/1997 |
ALB OR ALBUMIN |
CAROLINA LIQUID CHEMISTRIES CORP. |
CYNTHIA SHUGART |
| K971463 |
05/16/1997 |
ALP REAGENT SET |
CAROLINA LIQUID CHEMISTRIES CORP. |
CYNTHIA SHUGART |
| K971345 |
05/29/1997 |
CHOL OR CHOLESTEROL |
CAROLINA LIQUID CHEMISTRIES CORP. |
CYNTHIA SHUGART |
| K971396 |
05/29/1997 |
CK REAGENT |
CAROLINA LIQUID CHEMISTRIES CORP. |
CYNTHIA SHUGART |
| K971398 |
05/02/1997 |
LD-L REAGENT |
CAROLINA LIQUID CHEMISTRIES CORP. |
CYNTHIA SHUGART |
| K971466 |
05/06/1997 |
SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) |
CAROLINA LIQUID CHEMISTRIES CORP. |
CYNTHIA SHUGART |
| K971524 |
05/16/1997 |
TOTAL PROTEIN OR TP |
CAROLINA LIQUID CHEMISTRIES CORP. |
CYNTHIA SHUGART |
| K963803 |
05/23/1997 |
CENTOCOR CA 15-3 RIA MODEL NO. 800-033 |
CENTOCOR, INC. |
CHRISTOPHER ZALESKY |
| K970914 |
05/13/1997 |
CHASE AORTIC PERFUSION CANNULA |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K971041 |
05/13/1997 |
CHASE CORONARY OSTIAL PERFUSION CANNULA |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K964391 |
05/13/1997 |
CHASE LEFT VENT SAFETY VALVE |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K970746 |
05/09/1997 |
SEE3 (LOTRAFILCON A) SOFT CONTACT LENS |
CIBA VISION CORPORATION |
ALICIA M PLESNARSKI, RAC |
| K964337 |
05/23/1997 |
BETTER-BLADDER (BB) |
CIRCULATORY TECHNOLOGY, INC. |
YEHUDA TAMARI |
| K971584 |
05/23/1997 |
CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) |
CLARUS MEDICAL SYSTEMS, INC. |
DALE SAPPENFIELD |
| K971455 |
05/20/1997 |
CLARUS MODEL 5197 SIGHTLITE |
CLARUS MEDICAL SYSTEMS, INC. |
DALE SAPPENFIELD |
| K970672 |
05/22/1997 |
CRYSTAL-EEG MODEL 10 (MODEL 10) |
CLEVELAND MEDICAL DEVICES, INC. |
ROBERT N SCHMIDT |
| K971495 |
05/29/1997 |
PATHFINDER SUNGLASSES |
COIL |
E.J. Smith |
| K971202 |
05/27/1997 |
COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS |
COMEG ENDOSKOPIE GMBH |
PETER DUFFY |
| K963340 |
05/12/1997 |
MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE |
CONTINUUM BIOMEDICAL, INC. |
LAURIE A RIDENER |
| K970900 |
05/22/1997 |
INSTRUMENT HOLDER |
CONTOUR FABRICATORS, INC. |
MICHAEL CZOP |
| K970690 |
05/20/1997 |
LOCKING STYLET 2 |
COOK PACEMAKER CORP. |
NEAL E FEANOT, PH.D.;E.E. |
| K970842 |
05/28/1997 |
Cordis Endeavor Infusion Catheter |
CORDIS CORP. |
TAMARA YOUNT |
| K970620 |
05/06/1997 |
CORDIS OPTA5 PTA BALLOON CATHETER |
CORDIS CORP. |
MIRJAM BARBOZA |
| K963962 |
05/07/1997 |
VISTA BRITE TIP CATHETERS |
CORDIS CORP. |
KATHERINE TREVISOL |
| K951927 |
05/30/1997 |
COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER) |
CSEN LTD. |
JOSEPH ELDOR |
| K951928 |
05/30/1997 |
DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE) |
CSEN LTD. |
JOSEPH ELDOR |
| K970895 |
05/06/1997 |
CUSTOM OPTICAL SUNGLASS FRAMES |
CUSTOM OPTICAL FRAMES, INC. |
MARC H AST |
| K970676 |
05/02/1997 |
DRIED GRAM-NEGATIVE MIC/COMBO PANELS |
DADE INTL., INC. |
SHAROLYN J LENTSCH |
| K971376 |
05/30/1997 |
DRIED GRAM-NEGATIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
SHAROLYN J LENTSCH |
| K964518 |
05/14/1997 |
FAST-CATH TRANSSEPTAL CATHETER INTRODUCER |
DAIG CORP. |
JOHN C HEINMILLER |
| K971113 |
05/29/1997 |
DMA TRIGLYCERIDES PROCEDURES |
DATA MEDICAL ASSOCIATES, INC. |
C.H. MORRIS |
| K971104 |
05/06/1997 |
CLASSIC MATCH |
DELAGAR DIVISION BELCAM, INC. |
CALLY LUNETTA |
| K970813 |
05/08/1997 |
DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111 |
DENVU, INC. |
ROBERT S MCQUATE |
| K964114 |
05/06/1997 |
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS |
DEPUY, INC. |
CHERYL HASTINGS |
| K970600 |
05/08/1997 |
DERMAMEND FOAM ISLAND DRESSING |
DERMARX CORP. |
MARYANNE CARROLL |
| K971216 |
05/29/1997 |
FRIGIDERM FRIGISPRAY |
DERMATOLOGIC LAB & SUPPLY, INC. |
CORNELIA DAMSKY |
| K970993 |
05/22/1997 |
DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE |
DEROYAL INDUSTRIES, INC. |
MARIA EBIO |
| K970596 |
05/16/1997 |
DHD EMERALD PRODUCT |
DHD DIEMOLDING HEALTHCARE DIV. |
JEAN WALLACE |
| K971312 |
05/27/1997 |
IMMULITE PYRILINKS-D |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K971177 |
05/16/1997 |
IMMULITE VITAMIN B12 (LKVB1,LKVB5) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K965103 |
05/09/1997 |
WINMAX SOFTWARE SYSTEMS |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K971353 |
05/12/1997 |
DSL ACTIVE NON-EXTRACTION IGF-I ELISA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN WILLIS |
| K971270 |
05/22/1997 |
DSL ACTIVE T3 EIA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN WILLIS |
| K971269 |
05/22/1997 |
DSL ACTIVE T4 EIA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN WILLIS |
| K970915 |
05/16/1997 |
DSL ESTRONE-SULFATE RIA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN WILLIS |
| K961104 |
05/28/1997 |
NOTEBOOK IMAGER |
DIGIRAD CORP. |
JAMES M HOWARD |
| K970724 |
05/13/1997 |
QUICKPAC II ONE STEP METHAMPHETAMINE TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
| K971109 |
05/14/1997 |
QUIKPAC II ONE STEP AMPHETAMINE TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
| K971218 |
05/30/1997 |
QUIKSTRIP ONE STEP AMPHETAMINE TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
| K970457 |
05/08/1997 |
DUKAL ABD COMBINE PAD |
DUKAL CORP. |
PARTICK LAMB |
| K970455 |
05/08/1997 |
DUKAL NON ADHERENT DRESSING |
DUKAL CORP. |
PATRICK LAMB |
| K970104 |
05/06/1997 |
SANI-SHIELD |
DW INDUSTRIES, INC. |
TERRY G MAHN |
| K963738 |
05/23/1997 |
STELA MODEL BJ44 AND BJ45 PACING LEADS |
ELA MEDICAL, INC. |
CATHERINE G GOBLE |
| K964797 |
05/02/1997 |
EBI SPINELINK SYSTEM |
ELECTRO-BIOLOGY, INC. |
SHARON A STAROWICZ |
| K970980 |
05/29/1997 |
CARDIAC SCORING FOR CT SCANNERS |
ELSCINT, INC. |
THOMAS J SPACKMAN |
| K970491 |
05/30/1997 |
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES |
EMPI |
STACY MATTSON |
| K964178 |
05/05/1997 |
PRESS-FIT HIP STEM |
ENCORE ORTHOPEDICS, INC. |
ASHLEY M BOCK |
| K971125 |
05/23/1997 |
ENDO SMARTCAP (100501) |
ENDO SMART CAP CO. |
DON BYRNE |
| K960738 |
05/06/1997 |
STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H) |
ENGINEERED CUSTOM MFG., INC. |
ALLAN FRIEZE |
| K970605 |
05/22/1997 |
3-CCD DIGITAL CAMERA |
ENVISION MEDICAL CORP. |
DANIEL P MCGUIRE |
| K965045 |
05/05/1997 |
TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE |
ETHICON ENDO-SURGERY, INC. |
IVAN S PLACKO |
| K964702 |
05/20/1997 |
EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 |
EUCLID SYSTEMS CORP. |
ANNE MARIE CESARIO, R.A.C. |
| K971326 |
05/06/1997 |
ARROW COMPANY |
EXCEL EYEWEAR CORP. |
ROBERT SOMMER |
| K971286 |
05/08/1997 |
EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST |
EXCEL SCIENTIFIC, INC. |
MIN-LEE CHENG |
| K971327 |
05/09/1997 |
UNIKA |
EYEWEAR PARTNERS CO. |
MURRAY LEIBSON |
| K970909 |
05/06/1997 |
SAFE-CONNECT I.V. SET |
FAULDING MEDICAL DEVICE CO. |
BRUCE CRANEY |
| K970789 |
05/01/1997 |
SAFE-CONNECT VIAL DISPENSING SPIKE |
FAULDING MEDICAL DEVICE CO. |
BRUCE CRANEY |
| K971266 |
05/01/1997 |
SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518 |
FAULDING MEDICAL DEVICE CO. |
BRUCE CRANEY |
| K970280 |
05/22/1997 |
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K970257 |
05/22/1997 |
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K970258 |
05/22/1997 |
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K970892 |
05/05/1997 |
FIEGERT ENDOTECH CYSTOSCOPE |
FIEGERT, INC. |
ERNESTO HERNANDEZ |
| K970432 |
05/07/1997 |
INFANT RADIANT WARMER - MODELS IW910 AND IW920 |
FISHER & PAYKEL ELECTRONICS LTD. |
CHRIS MANDER |
| K964976 |
05/06/1997 |
FLOSSBRUSH WITH FLUORIDE |
FLOSSBRUSH INTERDENTAL CLEANER AND APPLICATOR |
EDWARD L LOEV, D.M.D. |
| K964187 |
05/01/1997 |
FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR |
FUKUDA DENSHI USA, INC. |
SUSAN D GOLDSTEIN-FALK |
| K970987 |
05/05/1997 |
ELECTROSURGICAL ELECTRODE |
FUSION MEDICAL TECHNOLOGIES, INC. |
DEBERA BROWN |
| K970872 |
05/21/1997 |
PAN (CHIBA ASPIRATING NEEDLE) |
GALLINI INTL., INC. |
PAUL L HAWTHORNE |
| K970871 |
05/21/1997 |
TR NEEDLE |
GALLINI INTL., INC. |
PAUL L HAWTHORNE |
| K970628 |
05/12/1997 |
GE ADVANTAGE DIGITIZER WORKSTATION |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER, PH.D. |
| K963055 |
05/02/1997 |
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 |
GenBio |
Bryan Kiehl |
| K963054 |
05/05/1997 |
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) |
GenBio |
Bryan Kiehl |
| K971217 |
05/06/1997 |
INSTRUMENT TRAY LINER |
GENERAL HOSPITAL SUPPLY CORP. |
PHILLIP DAVIS |
| K964796 |
05/14/1997 |
ODYSSEY I DENTAL WATER UNIT |
GERMIPHENE CORP. |
JOHN HUSNIK |
| K971239 |
05/12/1997 |
GREINER VACUETTE BLOOD COLLECTION TUBE |
GREINER AMERICA, INC. |
ED MAIER |
| K971236 |
05/12/1997 |
GREINER VACUETTE BLOOD COLLECTION TUBE |
GREINER AMERICA, INC. |
ED MAIER |
| K971221 |
05/02/1997 |
GREINER VACUETTE BLOOD COLLECTION TUBE |
GREINER AMERICA, INC. |
ED MAIER |
| K970469 |
05/08/1997 |
EVT ANGIOSCALE ANGIOGRAPHIC CATHETER |
GUIDANT CARDIAC AND VASCULAR SURGERY |
LUANNE TERMEER |
| K964188 |
05/06/1997 |
HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT |
HEALTHCARE SERVICE AND SUPPLY |
RICK ROEDER |
| K963904 |
05/15/1997 |
P.H.D. - PERSONAL HEART DEVICE MODEL 5258 |
HEART ALERT, INC. |
CATHY FAUST |
| K970496 |
05/09/1997 |
HEARTPORT MAZE SYSTEM: CRYOPROBE SET |
HEARTPORT, INC. |
MARIANNE C DRENNAN |
| K964302 |
05/09/1997 |
HEARTPORT THORACIC TROCAR |
HEARTPORT, INC. |
MARIANNE C DRENNAN |
| K971155 |
05/22/1997 |
MEMOREG |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K970848 |
05/06/1997 |
SILOC SYSTEM |
HERAEUS KULZER, INC. |
SHARON PARKER |
| K964832 |
05/15/1997 |
HEWLETT-PACKARD CENTRALVUE SOFTWARE |
HEWLETT-PACKARD CO. |
RAY STELTING |
| K964223 |
05/28/1997 |
CLINITRON RITE-HITE |
HILL-ROM, INC. |
EDWIN HILLS |
| K970295 |
05/16/1997 |
FLEXICAIR EXLIPSE PLUS |
HILL-ROM, INC. |
EDWIN BILLS |
| K954220 |
05/07/1997 |
EUB-8000 |
HITACHI MEDICAL CORP. OF AMERICA |
CHARLES F HOTTINGER |
| K970758 |
05/22/1997 |
DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K970908 |
05/20/1997 |
HOWTEK 960 |
HOWTEK, INC. |
M. RUSSELL LEONARD |
| K970476 |
05/06/1997 |
HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION) |
HWA MAO OPTICAL CO., LTD. |
ERIC CHEN |
| K965094 |
05/21/1997 |
HYCOR ALLERGEN DISC |
HYCOR BIOMEDICAL, INC. |
M. ALEM, PH.D. |
| K964972 |
05/05/1997 |
SHADOWFORM |
I.Z.I. MEDICAL PRODUCTS CORP. |
E.J. Smith |
| K971454 |
05/29/1997 |
TYMPANOSTOMY VENTILATION TUBE |
IKONOS CORP. |
ROBERT E ELLIS |
| K970750 |
05/05/1997 |
MICROSPAN INSEMINATION SYSTEM |
IMAGYN MEDICAL, INC. |
DEBRA A RINDERER |
| K964341 |
05/30/1997 |
IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT |
IMMCO DIAGNOSTICS, INC. |
RICHARD E GRECO |
| K964344 |
05/30/1997 |
IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT |
IMMCO DIAGNOSTICS, INC. |
RICHARD E GRECO |
| K964825 |
05/19/1997 |
FREEDOM TRAVELLER |
IMPACT CASE TECHNOLOGIES, INC. |
ANGELA HAMLEN |
| K963289 |
05/01/1997 |
INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY |
INCSTAR CORP. |
MARY FRICK |
| K971196 |
05/08/1997 |
ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM |
INNOVA CORP. |
HOWARD M HOLSTEIN |
| K964985 |
05/30/1997 |
QUANTA LITE IGG GLIADIN ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K963396 |
05/06/1997 |
BIOSPHERE SUTURE ANCHOR |
INSTRUMENT MAKAR, INC. |
ANDREW P ABOOD |
| K971777 |
05/27/1997 |
QUANTEX ASO-CRP-RF CONTROL |
INSTRUMENTATION LABORATORY CO. |
BETTY J LANE |
| K970658 |
05/19/1997 |
LUMBAR DRAINAGE ACCESSORY KIT |
INTEGRA NEUROCARE LLC. |
TERRY N LAYTON, PH.D. |
| K963256 |
05/09/1997 |
NEUROMATE STEREOTACTIC SYSTEM |
INTEGRATED SURGICAL SYSTEMS, S.A. |
JEAN-LUC BOULNOIS, PH.D. |
| K961229 |
05/29/1997 |
HR12000 ULTRASOUND SYSTEM |
INTERNATIONAL ULTRASOUND CORP. |
RAUL GUTIERREZ, R.T.,R.D.M.S. |
| K964625 |
05/05/1997 |
HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES |
INTERVASCULAR, INC. |
JAMES S MILLER |
| K964802 |
05/27/1997 |
CYBERJET LOCAL ANESTHESIA SYSTEM |
INTRA VANTAGE, INC. |
DAVID W SCHLERF |
| K970094 |
05/12/1997 |
MODEL DX MICRO COMPUTER CONTROL |
INVACARE RESPIRATORY CORP. |
EDWARD A KROLL |
| K971000 |
05/14/1997 |
EPISTAXIS NASAL PACK |
INVOTEC INTERNATIONAL, INC. |
JEFFREY L AULL |
| K971372 |
05/29/1997 |
VARIOLINK II |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K964961 |
05/14/1997 |
MODEL 405T WITH ETCO2 OPTION |
IVY BIOMEDICAL SYSTEMS, INC. |
DICK LISTRO |
| K971292 |
05/20/1997 |
JEL-71 PDF |
J.F. JELENKO & CO., INC. |
TRIDIB DASGUPTA |
| K971574 |
05/20/1997 |
JELBOND-PDF |
J.F. JELENKO & CO., INC. |
TRIDIB DASGUPTA |
| K970738 |
05/07/1997 |
KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT |
JAMIESON FILM CO. |
DAN NEWMAN |
| K971658 |
05/23/1997 |
MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT |
JAY H. GELLER |
JAY H GELLER |
| K963423 |
05/27/1997 |
KSEA CO2 ENDOFLATOR |
KARL STORZ ENDOSCOPY |
KEVIN A KENNAN |
| K971156 |
05/28/1997 |
KASHA VISUAL FIELD SYSTEM |
KASHA SOFTWARE, INC. |
|
| K971548 |
05/22/1997 |
AMBUVAC |
KINETIC CONCEPTS, INC. |
WILLIAM H QUIRK |
| K971341 |
05/22/1997 |
KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR |
KIRWAN SURGICAL PRODUCTS, INC. |
KEVIN PRARIO |
| K970997 |
05/22/1997 |
NEO-CARE LUMBER PUNCTURE KIT |
KLEIN-BAKER MEDICAL, INC. |
CLYDE N BAKER |
| K971297 |
05/08/1997 |
CENTRE-DRIVE DRILL-FREE SCREW |
KLS-MARTIN L.P. |
MIKE GREENE |
| K962009 |
05/20/1997 |
UROSTYM |
LABORIE MEDICAL TECHNOLOGIES, LTD. |
MIKE BARRE |
| K970948 |
05/21/1997 |
800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES |
LASERSCOPE |
LISA MCGRATH |
| K970454 |
05/06/1997 |
LAXIMA INTERNATIONAL LIMITED SUNGLASSES |
LAXIMA INTL., LTD. |
CHEN HAU CHEN |
| K970776 |
05/27/1997 |
LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT |
LIFECORE BIOMEDICAL, INC. |
DONNA BAHLS |
| K970556 |
05/12/1997 |
SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
JUDY MARTIN |
| K963369 |
05/22/1997 |
BIO-ANCHOR |
LINVATEC CORP. |
CAROL A WEIDEMAN, PH.D. |
| K971204 |
05/27/1997 |
LSVP INTERNATIONAL HOT BIOPSY FORCEPS |
LSVP INTL., INC. |
SOPHIA PESOTCHINSKY |
| K970642 |
05/21/1997 |
TENOSCOPE |
LUXTEC CORP. |
JOSEPH RESS |
| K970562 |
05/14/1997 |
TENOSNARE |
LUXTEC CORP. |
JOSEPH RESS |
| K964553 |
05/13/1997 |
MBI CO-AXIAL ILLUMINATED RETINAL PICK |
M.B. INDUSTRIES, INC. |
WILLIAM BUTTERMORE |
| K964405 |
05/13/1997 |
MBI ILLUMINATED RETINAL PICK |
M.B. INDUSTRIES, INC. |
WILLIAM J BUTTERMORE |
| K964256 |
05/06/1997 |
CYGNUS INSTRUMENT PROTECTORS |
MADISON POLYMERIC ENGINEERING |
SHAUN SWEENEY |
| K963767 |
05/16/1997 |
MANAN V.S. ACCESS NEEDLE/SET |
MANAN MEDICAL PRODUCTS, INC. |
MICHAEL PLISHKA |
| K970545 |
05/08/1997 |
DASH 1000 PATIENT MONITOR |
MARQUETTE MEDICAL SYSTEMS, INC. |
DIANNE SCHMITZ |
| K970685 |
05/28/1997 |
EARCHECK PRO |
MDI INSTRUMENTS, INC. |
SANDRA KIMBALL |
| K953647 |
05/16/1997 |
MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
STEPHEN B ANDERSON |
| K964710 |
05/09/1997 |
BLEDSOE COLD CONTROL |
MED TECHNOLOGY, INC. |
C. DAVID LITTLE |
| K971173 |
05/22/1997 |
ML DISPOSABLE ALK TUBING |
MED-LOGICS, INC. |
ROD ROSS |
| K970441 |
05/09/1997 |
K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH |
MEDI-FLEX HOSPITAL PRODUCTS, INC. |
PAT MCGRATH |
| K970757 |
05/09/1997 |
FOTONA SKINSCAN |
MEDICAL LASER SOLUTIONS |
IAIN D MILLER |
| K970639 |
05/15/1997 |
NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K |
MEDICOTEST, INC. |
EMALEE G MURPHY |
| K970536 |
05/12/1997 |
MEDISYSTEMS TRANDUCER PROTECTOR |
MEDISYSTEMS CORP. |
FRED G SWINDLER |
| K971208 |
05/13/1997 |
MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K963202 |
05/19/1997 |
MEGA ME 3000 PROFESSIONAL MUSCLE TESTER |
MEGA ELECTRONICS LTD. |
GREGORY J MATHISON |
| K964868 |
05/20/1997 |
2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER |
MICRO THERAPEUTICS, INC. |
LINDA D'ABATE |
| K970649 |
05/16/1997 |
HERO 642 |
MICRO-MEGA |
JM BADOZ |
| K971275 |
05/23/1997 |
MILL-ROSE DISPOSABLE POLYPECTOMY SNARE |
MILL-ROSE LABORATORY |
ALAN C POJE |
| K970652 |
05/02/1997 |
MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE |
MITRA IMAGING, INC. |
ERIC PETERSON |
| K970564 |
05/12/1997 |
DYNAMIC WEDGE |
MITSUBISHI ELECTRONICS AMERICA, INC. |
T. WHIT ATHEY |
| K970759 |
05/06/1997 |
SOLAR SPECS |
MORRIS ROSENBLOOM & CO., INC. |
GERALD N MURPHY |
| K971317 |
05/08/1997 |
NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS |
NATIONAL HEALTHCARE MFG. CORP. |
CAROLANN KOTULA |
| K964635 |
05/21/1997 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT |
NICHOLS INSTITUTE DIAGNOSTICS |
DAVE D SMITH |
| K970870 |
05/02/1997 |
DIGIT-GRIP WITH LCD (DGR002) |
NK BIOTECHNICAL CORP. |
KAREN GOTFREDSON |
| K970717 |
05/08/1997 |
VAPOR-TECH SLED ELECTRODE |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
| K970710 |
05/09/1997 |
STAT PROFILE ULTRA M ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K961631 |
05/12/1997 |
ODONT HEX SYSTEM |
ODONTIT SA |
MARIO GERSBERG |
| K970797 |
05/28/1997 |
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES |
OLYMPUS AMERICA, INC. |
SUBHASH R PATEL |
| K960068 |
05/05/1997 |
SH-1 SURGICAL HOLDER FOR TELESCOPE |
OLYMPUS AMERICA, INC. |
BARRY E SANDS |
| K970947 |
05/14/1997 |
B-350 CEILING MOUNTED C-POSITIONER |
OMEGA MEDICAL IMAGING, INC. |
DOUGLAS COON |
| K970716 |
05/16/1997 |
OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE |
OPTICON MEDICAL, INC. |
GREG SACHS |
| K970400 |
05/02/1997 |
BONE SOURCE HYDROXYAPATITE |
ORTHOFIX, INC. |
MARY BIGGERS |
| K971422 |
05/22/1997 |
OSTEONICS ACETABULAR WEDGE SYSTEM |
OSTEONICS CORP. |
TERRY SHERIDAN |
| K970779 |
05/09/1997 |
OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS |
OSTEONICS CORP. |
KATE SUTTON |
| K970647 |
05/20/1997 |
OUR ROTATING GAMMA SYSTEM |
OUR SCIENTIFIC INTL., INC. |
SUSAN D GOLDSTEIN-FALK |
| K970902 |
05/05/1997 |
MEDILOG FD4 |
OXFORD INSTRUMENTS MEDICAL SYSTEMS |
CHARLES HOLZ |
| K970509 |
05/12/1997 |
INNOFLOUR CALIBRATOR REAGENT SET |
OXIS INTL., INC. |
LYNDA M TAYLOR |
| K970510 |
05/12/1997 |
INNOFLOUR TOPIRAMATE REAGENT SET |
OXIS INTL., INC. |
LYNDA M TAYLOR |
| K970517 |
05/12/1997 |
INNOFLUOR TOPIRAMATE CONTROL SET |
OXIS INTL., INC. |
LYNDA M TAYLOR |
| K970189 |
05/21/1997 |
FIF TM |
PANBIO, INC. |
LINDA M WILLIAMS |
| K963166 |
05/05/1997 |
O'REGAN LIGATOR |
PATRICK J. O'REGAN |
PATRICK J O'REGAN |
| K971389 |
05/09/1997 |
ECLIPSE 400 MANUALLY OPERATED WHEELCAIR |
PDG PRODUCT DESIGN GROUP, INC. |
PHIL MUNDY |
| K971365 |
05/14/1997 |
PHILIPS INTEGRIS H5000 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K963990 |
05/29/1997 |
GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES |
PHILIPS MEDICAL SYSTEMS, INC. |
PETER ALTMAN |
| K970604 |
05/19/1997 |
VIEWPOINT - 3.0 SOFTWARE |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER, PH.D. |
| K970694 |
05/14/1997 |
MODEL 1700, HYDRO PREP |
PHYSIOMETRIX, INC. |
DAWN E FRAZER |
| K970174 |
05/01/1997 |
FREEPIX/PIXPACS DICOM/HTTP GATEWAY |
PIXELINKS, INC. |
STEVE BEER |
| K971174 |
05/21/1997 |
PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS |
PLAYTEX, INC. |
IRWIN BUTENSKY |
| K970933 |
05/23/1997 |
AUTO HDL CHOLESTEROL CALIBRATOR |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS, JR. |
| K971045 |
05/02/1997 |
BASIS FLEXIBLE TIP DIGITAL THERMOMETER |
POLYMEDICA INDUSTRIES, INC. |
SUSAN COLLINS |
| K970698 |
05/06/1997 |
BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS |
POLYMER TECHNOLOGY CORP. |
DOUGLAS J FORTUNATO |
| K970234 |
05/02/1997 |
SEALED LEAD ACID BATTERY PACK |
PORTABLE POWER SYSTEMS, INC. |
NORMAN A PREMO |
| K933841 |
05/05/1997 |
CENTAURI |
PREMIER LASER SYSTEMS, INC. |
COLLETE COZEAN |
| K932683 |
05/05/1997 |
CENTAURI |
PREMIER LASER SYSTEMS, INC. |
COLETTE COZEAN |
| K965143 |
05/22/1997 |
OSMOCYTE WOUND MANAGER SHEET DRESSING |
PROCYTE CORP. |
PAUL KETTERIDGE |
| K964978 |
05/21/1997 |
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) |
QUINTON, INC. |
MATTHEW HEDLUND |
| K964767 |
05/29/1997 |
QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
| K970718 |
05/27/1997 |
QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) |
R & D SYSTEMS, INC. |
KENNETH T EDDS, PH.D. |
| K970641 |
05/02/1997 |
RIS SCANVIEW SYSTEM (RSVS) |
RADIOLOGY INFORMATION SYSTEMS, INC. |
JOE S PI |
| K970466 |
05/20/1997 |
RADIUS PTCA GUIDEWIRE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
MAUREEN A FINLAYSON |
| K970684 |
05/07/1997 |
LACTATE DEHYDROGENASE (LD) |
RANDOX LABORATORIES, LTD. |
PONE ARMSTRONG |
| K971432 |
05/20/1997 |
PROSPORE |
RAVEN BIOLOGICAL LABORATORIES, INC. |
KERRIE GROFF |
| K971430 |
05/22/1997 |
PROSPORE II |
RAVEN BIOLOGICAL LABORATORIES, INC. |
RUSS NYBERG |
| K970516 |
05/09/1997 |
SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM |
RESMED LTD. |
MICHAEL HALLETT |
| K970428 |
05/14/1997 |
REST X SYSTEM |
RESTXSYS |
YOAV GERSHONI |
| K970803 |
05/29/1997 |
ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE |
RETRACTABLE TECHNOLOGIES, INC. |
TERANCE GRISSO |
| K964329 |
05/21/1997 |
UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM) |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K964506 |
05/21/1997 |
ROCHE COBAS AMPLICOR ANALYZER |
ROCHE MOLECULAR SYSTEMS, INC. |
ALEX WESOLOWSKI |
| K963779 |
05/23/1997 |
RUSCH ENTERAL FEEDING TUBE |
RUSCH, INC. |
RONALD J YOUNG |
| K970899 |
05/06/1997 |
SAFESKIN POWDERED EXAMINATION GLOVE |
SAFESKIN CORP. |
MICHELLE MOLLOY |
| K970850 |
05/14/1997 |
SCANRITE DFS |
SCANRITE SYSTEMS |
BARRY J WALTER |
| K971526 |
05/21/1997 |
ACE HDL-C REAGENT |
SCHIAPPARELLI BIOSYSTEMS, INC. |
STEVE DALESSIO |
| K970494 |
05/09/1997 |
HANNIBAL GUIDEWIRE |
SCHNEIDER (EUROPE) GMBH |
RUDOLF OTT |
| K964551 |
05/21/1997 |
CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID |
SCIMED LIFE SYSTEMS, INC. |
CONNIE J DEL TORO |
| K970944 |
05/06/1997 |
BARAKKA, INFERNO, STERLING, AND/OR ONE |
SENTINAL IMPORTING CORP. |
BRENT MARTIN |
| K971415 |
05/23/1997 |
VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE |
SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. |
TIANG S CHANG |
| K971423 |
05/23/1997 |
VINYL PATIENT EXAMINATION GLOVE, POWDERED |
SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. |
TIANG S CHANG |
| K963068 |
05/29/1997 |
CTS-200 WITH EZU-PL21 TRANSDUCER |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
ROBERT MORTON |
| K963065 |
05/29/1997 |
CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
ROBERT MORTON |
| K970824 |
05/30/1997 |
MDX 2000, DIGITAL ANALYZER |
SHOTWELL & CARR, INC. |
BERT HUDSON |
| K970794 |
05/06/1997 |
LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) |
SIAM SEMPERMED CORP. LTD. |
POONSUK CHERDKIATGUMCHAI |
| K964069 |
05/08/1997 |
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K971452 |
05/14/1997 |
MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JEFFREY W KOONTZ |
| K970368 |
05/06/1997 |
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAQUELINE EMERY |
| K962142 |
05/29/1997 |
SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
STEVE HESLER |
| K970249 |
05/07/1997 |
SIMPLEX AIRBRATOR |
SIMPLEX MEDICAL SYSTEMS, INC. |
JOHN E TRAFTON |
| K971403 |
05/29/1997 |
SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE |
SJ MEDICAL PRODUCTS (M) SDN BHD |
FOO KNON PU |
| K965224 |
05/08/1997 |
EMPOWER ANTERIOR DIRECT SCREWS |
SMITH & NEPHEW RICHARDS, INC. |
THOMAS L CRAIG |
| K970748 |
05/09/1997 |
TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM |
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
JOANNE KUHNE |
| K945590 |
05/20/1997 |
SCOPETEX(TM) |
SMITH HELMS MULLISS & MOORE, L.L.P. |
CHRISTINE T NERO |
| K970806 |
05/02/1997 |
ACPII ANTERIOR CERVICAL PLATE SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K970999 |
05/20/1997 |
SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR |
SONY MEDICAL SYSTEMS |
CYNTHIA A SINCLAIR |
| K970702 |
05/12/1997 |
SPECTRUM DESIGNS SPECTRAGEL |
SPECTRUM DESIGNS, INC. |
JIM DISHMAN |
| K964239 |
05/09/1997 |
COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER |
SPEGAS INDUSTRIES, LTD. |
YACOV BUBIS |
| K970952 |
05/02/1997 |
PRECISE IMPRESSION KIT |
STARKEY LABORATORIES, INC. |
SHARI L SWIDEN |
| K970490 |
05/02/1997 |
PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT |
STELKAST COMPANY |
DONALD A STEVENS |
| K971390 |
05/15/1997 |
QUANTUM 3080SP SURGICAL TABLE |
STERIS Corporation |
LORI HALLER |
| K960441 |
05/08/1997 |
STERITEC INTEGRAPH MODEL CI-101 |
STERITEC PRODUCTS MFG. CO., INC. |
PAUL A PAGE |
| K970706 |
05/22/1997 |
INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES |
SULZER ORTHOPEDICS, INC. |
SHAVAWN PARDUHN |
| K970705 |
05/22/1997 |
INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES |
SULZER ORTHOPEDICS, INC. |
SHAVAWN PARDUHN |
| K971338 |
05/06/1997 |
SYNTEC, INC. DISPOSABLE BARE END FIBER |
SYNTEC, INC. |
NATHAN H LEWIS |
| K961608 |
05/09/1997 |
SYNTHES (U.S.A.) POLYPIN |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K971544 |
05/28/1997 |
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K971277 |
05/20/1997 |
SAFE-T-CLAMP |
TALON MEDICAL, LTD. |
DAVID COCKE |
| K971412 |
05/13/1997 |
SUNGLASSES |
TEAM CHIEN INDUSTRIAL CO., LTD. |
KUO-TAI KUO |
| K971613 |
05/22/1997 |
SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING |
TECHNICAL PRODUCTS, INC. |
NORBERT D THOMPSON |
| K970659 |
05/16/1997 |
DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER |
TELEDIAGNOSTIC SYSTEMS, INC. |
LARRY WOODARD |
| K970463 |
05/06/1997 |
CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR |
TERUMO MEDICAL CORP. |
SANDI HARTKA |
| K970530 |
05/05/1997 |
ANSPACH LUBRICATING SYSTEM II |
THE ANSPACH EFFORT, INC. |
WILLIAM E ANSPACH III, MD |
| K965133 |
05/21/1997 |
ANCA COMBI DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K964869 |
05/14/1997 |
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR |
THE MAGSTIM COMPANY LTD. |
C. HOVEY |
| K964607 |
05/28/1997 |
THERATON 1000E |
THERATRONICS, INC. |
E.S. MARTELL |
| K964605 |
05/16/1997 |
BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000) |
THERMOSCAN, INC. |
FRANCES E HARRISON |
| K961805 |
05/09/1997 |
TOMEY DTL ELECTRODE |
TOMEY CORPORATION USA |
SUSUMU NOZAWA |
| K971477 |
05/27/1997 |
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) |
TRACE AMERICA, INC. |
David Johnston |
| K971485 |
05/27/1997 |
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
DAVID JOHNSON |
| K963418 |
05/02/1997 |
TRANSMEDICA MODEL 100 DIGITAL ELECTRONIC STETHOSCOPE |
TRANSMEDICA, INC. |
SAILOR H MOHLER |
| K970890 |
05/23/1997 |
#ES-32 SUCTION CATHETER 32 FR. |
TRI-MED SPECIALTIES, INC. |
MIKE KNOTH |
| K970982 |
05/09/1997 |
T-RX RETRIEVAL FORCEPS |
TRI-MED SPECIALTIES, INC. |
MIKE KNOTH |
| K964438 |
05/29/1997 |
511 KEV COLLIMATOR |
TRIONIX RESEARCH LABORATORY, INC. |
DAPHNE REED |
| K971319 |
05/22/1997 |
NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES |
TYCOM DENTAL |
CAROL PATTERSON |
| K971431 |
05/20/1997 |
UMI X-RAY FILM CASSETTE |
UMI INTL. |
KWANG CHAE JUNG |
| K970828 |
05/28/1997 |
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER |
UNITED HEARING SYSTEMS, INC. |
RALPH CAMPAGNA |
| K970945 |
05/07/1997 |
ANGLED TIP POLYPECTOMY SNARE |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN YOUNKER-COHEN |
| K970863 |
05/05/1997 |
MODIFIED USSC* POLYSORB SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JONATHAN GILBERT |
| K964251 |
05/23/1997 |
OCCLUSION CLAMP** DEVICE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
VICTOR CLAVELLI |
| K970692 |
05/08/1997 |
UNITRON MODEL SOUND F/X CIC |
UNITRON INDUSTRIES, INC. |
JERRY G JOHNSON |
| K970077 |
05/23/1997 |
LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) |
UTAH MEDICAL PRODUCTS, INC. |
NADEEM AHMED |
| K963622 |
05/07/1997 |
VAIL 2000 ENCLOSED BED |
VAIL PRODUCTS, INC. |
NANCY VAIL |
| K970725 |
05/09/1997 |
OPTI-PLAST XL 5.5 F PTA CATHETER |
VAS-CATH, INC. |
JANET SHAW |
| K964881 |
05/28/1997 |
ULTRAVERSE PTA CATHETER |
VAS-CATH, INC. |
DOLORES MCGIRR |
| K971373 |
05/20/1997 |
VISTA SINGLE CHIP VIDEO CAMERA |
VISTA MEDICAL TECHNOLOGIES, INC. |
MARTIN NEWMAN |
| K970884 |
05/08/1997 |
RESOLUT REGENERATIVE MATERIAL |
W.L. GORE & ASSOCIATES,INC |
JACQUELINE KALBACH |
| K970986 |
05/07/1997 |
WAKO DIRECT BILIRUBIN V |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K965052 |
05/14/1997 |
D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES |
WESLEY JESSEN CORP. |
RICK MAIN |
| K971231 |
05/19/1997 |
WHITE RIVER MINI MANUAL BREAST PUMP |
WHITE RIVER CONCEPTS |
E.J. Smith |
| K970974 |
05/02/1997 |
WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER |
WILLIAMS SOUND, LLC |
PAUL INGEBRIGTSEN |
| K970665 |
05/02/1997 |
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER |
WILLIAMS SOUND, LLC |
PAUL INGEBRIGTSEN |
| K970687 |
05/02/1997 |
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER |
WILLIAMS SOUND, LLC |
PAUL INGEBRIGTSEN |
| K952545 |
05/28/1997 |
WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM |
WRIGHT INDUSTRIES |
CHARLES WRIGHT |
| K963562 |
05/07/1997 |
WRIGHT PLASTER OF PARIS PELLETS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ROBERT CHURINETZ |
| K971124 |
05/16/1997 |
TM MICRO-CATHETERS |
XOMED, INC. |
DAVID TIMLIN |
| K970910 |
05/02/1997 |
XOMED SILICONE BLOCK/STRIP |
XOMED, INC. |
DAVID TIMLIN |
| K970315 |
05/06/1997 |
EVEREST SUNGLASSES |
YCC INTERNATIONAL CORP. |
LIHUA WANG |
| K970699 |
05/13/1997 |
AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES |
YEONG JIUH CORP. |
JOHN L'EPAGNIOL |
| K963781 |
05/20/1997 |
ZOLL AUTOCLAVABLE INTERNAL HANDLES |
ZOLL MEDICAL CORP. |
MAURA MCGUIRE |
