| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K974445 |
07/26/1998 |
3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 |
3M HEALTH CARE |
LINDA JOHNSEN |
| K982094 |
07/22/1998 |
VERABOND 2 |
AALBA DENT, INC. |
VINCENT BENETTI |
| K981614 |
07/17/1998 |
NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL |
AARON MEDICAL INDUSTRIES |
J.ROBERT SARON |
| K980877 |
07/06/1998 |
ETEST CEFDINIR |
AB BIODISK |
ANNE BOLMSTROM |
| K981814 |
07/22/1998 |
ALBP |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981920 |
07/22/1998 |
AMM |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981706 |
07/09/1998 |
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981799 |
07/22/1998 |
CREA |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981943 |
07/22/1998 |
DBIL |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981654 |
07/22/1998 |
TIBC |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K982041 |
07/30/1998 |
UIBC |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K981918 |
07/28/1998 |
UREA |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K972538 |
07/15/1998 |
FLOW-EZE BLUNT CANNULA (1999BC) |
ACACIA, INC. |
JAMES J SULLIVAN |
| K981574 |
07/06/1998 |
OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION |
ALCON |
MICHAEL PFLEGER |
| K981561 |
07/24/1998 |
LIQUID ENZYME ID 90133 |
ALCON LABORATORIES |
RALPH H LARSEN |
| K981571 |
07/09/1998 |
MONARCH IOL DELIVERY SYSTEM |
ALCON LABORATORIES |
MARTIN A KAUFMAN |
| K980648 |
07/20/1998 |
PRO VISION |
ALGOTEC SYSTEMS, LTD. |
ELI M ORBACH |
| K982269 |
07/23/1998 |
CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA |
ALLEGIANCE HEALTHCARE CORP. |
ZARINA B ILGRAMI |
| K981818 |
07/10/1998 |
CONVERTORS TRILAMINATE DRAPES |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K980775 |
07/06/1998 |
COMPLETE BRAND MULTI-PURPOSE SOLUTION |
ALLERGAN, INC. |
PAUL J NOWACKI |
| K970679 |
07/23/1998 |
ALTRA FLUX 200 HEMODIALYZER |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
AMAURY SANCHEZ |
| K970681 |
07/23/1998 |
ALTRA NOVA 200 HEMODIALYZER |
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
AMAURY SANCHEZ |
| K981891 |
07/17/1998 |
AMBU TUBECHECK |
AMBU, INC. |
SANJAY H PARIKH |
| K981396 |
07/30/1998 |
PYLORIPROBE |
AMDL, INC. |
THAT T NGO |
| K981533 |
07/15/1998 |
AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 |
AMERICAN TELECARE, INC. |
GERARD J PRUD'HOMME |
| K980638 |
07/06/1998 |
ADI SYPHILIS RPR LIQUID CONTROLS |
AMPCOR DIAGNOSTICS, INC. |
RAYMOND MILLER |
| K981827 |
07/28/1998 |
VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM |
ANGIOLAZ, INC. |
JOHN D PLUMADORE |
| K981821 |
07/29/1998 |
VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR |
ANGIOLAZ, INC. |
JOHN D PLUMADORE |
| K973980 |
07/29/1998 |
ACU-STIM TENS, AP-101082T |
APEX MEDICAL CORP. |
DANIEL LEE |
| K973978 |
07/29/1998 |
MICRO II MICROCURRENT TENS |
APEX MEDICAL CORP. |
DANIEL LEE |
| K973979 |
07/29/1998 |
MULTI-STIM TENS, AP-101081T |
APEX MEDICAL CORP. |
DANIEL LEE |
| K981187 |
07/01/1998 |
ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 |
ARTHREX, INC. |
SCOTT M DURLACHER |
| K981967 |
07/17/1998 |
WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE |
ARTHROTEK/BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K981294 |
07/08/1998 |
ODYSSEY INSTRUMENTATION SYSTEM |
AUTOMATA INSTRUMENTATION, INC. |
LINDA V MASANO |
| K981715 |
07/29/1998 |
DISTAL RADIUS FRACTURE FIXATION PLATE |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K981716 |
07/17/1998 |
EXTERNAL FIXATION |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K980487 |
07/07/1998 |
CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM |
BAXTER EDWARDS |
LARRY WOOD |
| K974652 |
07/10/1998 |
BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
| K972846 |
07/17/1998 |
BMC RF CANNULA |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
| K980185 |
07/17/1998 |
COLORPAC TOXIN A |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
COLLEEN A ROHRBECK |
| K972728 |
07/15/1998 |
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS) |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
MICHAEL GROSS |
| K982022 |
07/06/1998 |
VIGIL HEMOGLOBIN (HBALC) CONTROLS |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K982224 |
07/09/1998 |
VIGIL PROTEIN CONTROL |
BECKMAN COULTER, INC. |
RICHARD T ROSS |
| K982250 |
07/14/1998 |
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
BECKMAN INSTRUMENTS, INC. |
SHELLIE GUST |
| K981674 |
07/28/1998 |
POWDERED GREEN NITRILE EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
LEE A LIM |
| K981673 |
07/28/1998 |
POWDERFREE GREEN NITRILE EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
LEE A LIM |
| K981675 |
07/28/1998 |
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) |
BESGLOVE MEDICARE SDN. BHD. |
LEE A LIM |
| K982282 |
07/30/1998 |
DURA-GUARD - DURAL REPAIR PATCH |
BIO-VASCULAR, INC. |
MARY FRICK |
| K981798 |
07/13/1998 |
LACTOSORB POP RIVET |
BIOMET, INC. |
JULIE K RYAN |
| K981459 |
07/14/1998 |
MEMBRANE TACK |
BIOMET, INC. |
MARY VERSTYNEN |
| K981358 |
07/13/1998 |
ARTOSCAN S |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
| K981083 |
07/22/1998 |
RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000 |
BIOTRONIK, INC. |
LAUREN L FOOTE CHRISTENSEN |
| K971971 |
07/10/1998 |
BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK |
BOARD OF DIRECTORS, ALBERT BROWNE LTD. |
CYNTHIA J. M. NOLTE |
| K981883 |
07/07/1998 |
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 |
BOEHRINGER MANNHEIM CORP. |
LUANN OCHS |
| K982184 |
07/21/1998 |
WALLSTENT ENDOPROSTHESIS |
BOSTON SCIENTIFIC SCIMED, INC. |
PHILIP B JARVI |
| K980920 |
07/16/1998 |
EQUINOXE |
BOUVIER HYDRO, INC. |
ALAIN JOUAN |
| K980962 |
07/29/1998 |
BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO |
BRENNEN MEDICAL, INC. |
KENNETH B HERLAND |
| K981215 |
07/01/1998 |
PSI-TEC LIPOSUCTION ASPIRATOR |
BYRON MEDICAL |
STEVE BOLLINGER |
| K981601 |
07/28/1998 |
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER |
CALIFORNIA MEDICAL LABORATORIES, INC. |
MEHMET BICAKCI |
| K981351 |
07/13/1998 |
CANDELA GENTLELASE GL DERMATOLOGICAL LASER |
CANDELA CORP. |
JAY CAPLAN |
| K971975 |
07/01/1998 |
CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER |
CARDIMA, INC. |
JACK P DOUGLAS |
| K980128 |
07/24/1998 |
BALADI INVERTER WITH COAXIAL AORTIC PUNCH |
CARDIO MEDICAL SOLUTIONS, INC. |
THOMAS P SCHROEDER |
| K980879 |
07/16/1998 |
OSCILLOMATE NIBP / SP02 EMS MONITOR |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K981182 |
07/02/1998 |
OSTEOGRAF/N-300 |
CERAMED DENTAL, LLC. |
MARK BOWERMAN |
| K980389 |
07/29/1998 |
MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES |
CERAMOPTEC, INC. |
JONATHAN S KAHAN |
| K981415 |
07/14/1998 |
0-20 CM H20 PEEP VALVE |
CHEEN HOUNG ENT. CO. LTD. |
JAY WANG |
| K981698 |
07/10/1998 |
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) |
CHIRON CORP. |
NANCY A HORNBARKER |
| K981592 |
07/07/1998 |
ACS:CENTAUR AFP |
CHIRON DIAGNOSTICS CORP. |
THOMAS F FLYNN |
| K980573 |
07/30/1998 |
SENSOREX BLOOD GLUCOSE MONITORING SYSTEM |
CHRONIMED, INC. |
JEFFREY P HEATON |
| K981611 |
07/30/1998 |
SNAP-N-PEEL INTRODUCERS |
CIRCON CORP. |
RONALD J EHMSEN |
| K980912 |
07/22/1998 |
VCA IGG ELISA TEST SYSTEM |
CLARK LABORATORIES, INC. |
WILLIAM L BOTELER JR |
| K980596 |
07/22/1998 |
VCA IGM ELISA TEST SYSTEM |
CLARK LABORATORIES, INC. |
WILLIAM L BOTELER, JR. |
| K980787 |
07/13/1998 |
HERMES OPERATING ROOM CONTROL CENTER WITH THE WOM 20L INSUFFLATOR |
COMPUTER MOTION, INC. |
DOUGLAS P BUESCHEL |
| K974801 |
07/09/1998 |
SINGLE CHANNEL BALLOON CANNULA |
CONKIN SURGICAL INSTRUMENTS LTD. |
KINA MARKOFF |
| K981804 |
07/24/1998 |
XENON LIGHT SOURCE MODEL LS6000 |
CONTEC MEDICAL VISION, LTD. |
ALBERT E AUSTIN |
| K981589 |
07/30/1998 |
ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES |
CONWAY STUART MEDICAL, INC. |
THOMAS WEHMAN |
| K980670 |
07/17/1998 |
CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722 |
CRYOMEDICAL SCIENCES, INC. |
RICHARD J REINHART PH.D. |
| K980668 |
07/17/1998 |
CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790 |
CRYOMEDICAL SCIENCES, INC. |
RICHARD J REINHARD, PH.D. |
| K981428 |
07/07/1998 |
ANU ICE |
CRYOPTHERAPY PAIN RELIEF PRODUCTS, INC. |
JORGE CABALLERO |
| K981469 |
07/09/1998 |
CERMAX300 LIGHTSOURCE |
CUDA PRODUCTS CO. |
KIM REED |
| K972899 |
07/07/1998 |
CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER |
CYPRESS MEDICAL PRODUCTS, LTD. |
ANTHONY L GIACCIO |
| K982210 |
07/09/1998 |
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA |
DADE BEHRING, INC. |
PAUL ROGERS |
| K974343 |
07/22/1998 |
DADE INNOVIN |
DADE INTL., INC. |
RADAMES RIESGO |
| K980635 |
07/22/1998 |
DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 |
DAKO CORP. |
GRETCHEN M MURRAY, PH.D., RAC |
| K982154 |
07/13/1998 |
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM |
DANEK MEDICAL, INC. |
RICHARD W TREHARNE |
| K981582 |
07/13/1998 |
SURGILON, DERMALON, & OPHTHALON |
DAVIS & GECK, INC. |
VANADA JOHNSON |
| K981956 |
07/09/1998 |
DEGANIA SILICONE IDENTI LOOPS |
DEGANIA SILICONE, LTD. |
BETTE LUBIN |
| K981965 |
07/10/1998 |
FLOWABLE COMPOSITE |
DENTSPLY INTL. |
P. JEFFREY LEHN |
| K981620 |
07/31/1998 |
MTA MATERIAL II |
DENTSPLY INTL. |
JEFFERY P LEHN |
| K982007 |
07/22/1998 |
TRUBYTE DENTURE BOND DENTURE BONDING AGENT |
DENTSPLY INTL. |
P J LEHN |
| K981775 |
07/29/1998 |
DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE |
DEPUY ACE MEDICAL CO. |
PAUL DONER |
| K982443 |
07/29/1998 |
DOC VENTRAL CERVICAL STABILIZATION SYSTEM |
DEPUY MOTECH ACROMED |
WILLIAM CHRISTIANSON |
| K981487 |
07/13/1998 |
DEPUY GLOBAL SHOULDER GLENOID |
DEPUY ORTHOPAEDICS, INC. |
SALLY FOUST |
| K974763 |
07/10/1998 |
DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA |
DEROYAL INDUSTRIES, INC. |
CAMILLE MATTLOCK |
| K981941 |
07/29/1998 |
MULTAPORT CANNULA REDUCER AND ACCESSORIES |
DEXIDE, INC. |
LYNETTE CALDWELL |
| DEN980003 |
07/17/1998 |
DIAMOND PROBE/PERIO 2000 SYSTEM |
DIAMOND GENERAL DEVELOPMENT CORP. |
DALE E SEAMON |
| K981438 |
07/20/1998 |
DORNIER MEDILAS E |
DORNIER SURGICAL PRODUCTS, INC. |
CAROL WERENCKE |
| K981718 |
07/17/1998 |
DORNIER MEDILAS H |
DORNIER SURGICAL PRODUCTS, INC. |
CAROL WERNECKE |
| K973636 |
07/27/1998 |
MCS-MEDICATED CANAL SEALER |
DR. HOWARD MARTIN, P.A. |
KYLE H SIBINOVIC |
| K981773 |
07/06/1998 |
DRAGER-VAPOR 19.3 |
DRAEGER MEDICAL, INC. |
J. TERESA DORRIETY |
| K973430 |
07/17/1998 |
KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM |
EASTMAN KODAK COMPANY |
PHIL AMATO |
| K981483 |
07/08/1998 |
EBI DFS JOINT FIXATOR, MODEL 02800 |
ELECTRO-BIOLOGY, INC. |
JON CAPAROTTA |
| K980177 |
07/07/1998 |
SUGITRON MODEL: IEC |
ELLMAN INTL., INC. |
FRANK LIN |
| K981926 |
07/22/1998 |
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS |
EMD CHEMICALS INC. |
ANNA G BENTLEY |
| K981800 |
07/06/1998 |
SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606 |
EQUAL DIAGNOSTICS, INC. |
BRENDA Y KAN |
| K980094 |
07/28/1998 |
MODIFICATION TO THE OXYCONALPHA |
ERICH JAEGER B.V. |
LEO D BAKKER |
| K981579 |
07/09/1998 |
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG |
ETHICON, INC. |
GREGORY R JONES |
| K981361 |
07/13/1998 |
POWERSTAR BIPOLAR SCISSORS |
ETHICON, INC. |
GREGORY R JONES |
| K981708 |
07/23/1998 |
DENTAL PORCELAIN-VARIOUS |
EXCEL PORCELAIN PRODUCTS |
ANDREW J PIETROBONO |
| K982118 |
07/24/1998 |
CARESIDE ANALYZER |
EXIGENT DIAGNOSTICS, INC. |
KENNETH B ASARCH |
| K981899 |
07/14/1998 |
CARESIDE HDL-CHOLESTEROL |
EXIGENT DIAGNOSTICS, INC. |
KENNETH B ASARCH |
| K972700 |
07/16/1998 |
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) |
EXMOOR PLASTICS LTD. |
MARGARET BLACKMORE |
| K980822 |
07/09/1998 |
TITANIUM PEG SYSTEM |
FCI OPHTHALMICS, INC. |
ANNE BOHSACK |
| K981414 |
07/16/1998 |
LC POSITIONER |
FISCHER IMAGING CORP. |
SAMUEL D EMRICH |
| K973161 |
07/10/1998 |
CPAP HUMIDIFIER (HC 200) |
FISHER & PAYKEL ELECTRONICS LTD. |
CHRIS MANDER |
| K981813 |
07/10/1998 |
PERMACEM AUTOMIX LUTING CEMENT SYSTEM |
FOREMOST DENTAL MFG., INC. |
AN-SHIH CHENG |
| K980501 |
07/08/1998 |
SKINTONER SYSTEM |
FULLER RESEARCH CORP. |
JOSEPH MUCCINI |
| K973456 |
07/22/1998 |
SPIROBANK PORTABLE PC BASED SPIROMETER |
FUTUREMED AMERICA, INC. |
MICHAEL DAVIDSON |
| K980913 |
07/01/1998 |
CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 |
GALIL MEDICAL LTD. |
JONATHAN S KAHAN |
| K981301 |
07/08/1998 |
SPEED-CUT AUTOMATIC BIOPSY SYSTEM |
GALLINI U.S., LLC. |
PAUL L HAWTHORNE |
| K981486 |
07/01/1998 |
STAIR-LIFT |
GARAVENTA (CANADA) LTD. |
ALYSSA CHUMNANVECH |
| K974715 |
07/06/1998 |
ADVANTAGE 3D XR |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K981352 |
07/13/1998 |
VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402 |
GE MEDICAL SYSTEMS F.I. HAIFA |
YAIR FRIEDMAN |
| K972817 |
07/24/1998 |
RESOR-PIN RESORBABLE MEMBRANE PIN |
GEISTLICH-PHARMA |
PETER S REICHERTZ |
| K981322 |
07/07/1998 |
CUTALON NYLON POLYAMIDE SURGICAL SUTURE |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
JIM KENNEY |
| K981575 |
07/15/1998 |
TYMPANOSTOMY TUBE |
Grace Medical, Inc. |
ANTHONY D PRESCOTT |
| K974730 |
07/14/1998 |
SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) |
GRAPHIC CONTROLS CORP. |
KATHLEEN H SELOVER |
| K981856 |
07/29/1998 |
MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) |
GREATBATCH SCIENTIFIC |
GARY J SFEIR |
| K981619 |
07/15/1998 |
VACUETTE MULTIPLE SAMPLE LUER ADAPTER |
GREINER MEDITECH, INC. |
DOUGLAS L HARRIS |
| K981524 |
07/10/1998 |
PRILANE |
GRESCO PRODUCTS, INC. |
CLINTON D VAUPEL |
| K981381 |
07/15/1998 |
ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1 |
GUIDANT CORP. |
MARGARET ANDERSON |
| K981618 |
07/28/1998 |
LIQUID A |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K974736 |
07/15/1998 |
HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER |
HEARTPORT, INC. |
MARIANNE C DRENNAN |
| K981546 |
07/15/1998 |
NTI CLENCHING SUPPRESSION SYSTEM |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K974457 |
07/14/1998 |
SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T |
HEWLETT-PACKARD CO. |
ROB BUTLER |
| K981576 |
07/17/1998 |
MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
| K981794 |
07/29/1998 |
HICHEM CALCIUM REAGENT KIT |
HICHEM DIAGNOSTICS |
WYNN STOCKING |
| K981434 |
07/27/1998 |
EUP-OL334 LAPARASCOPICPROBE |
HITACHI MEDICAL CORP. OF AMERICA |
CHARLES F HOTTINGER |
| K972401 |
07/13/1998 |
HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K974837 |
07/06/1998 |
IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS |
IGEL VISION CARE PTE LTD. |
JOHN M SZABOCSIK |
| K970069 |
07/17/1998 |
DUAL HOOK FIBEROPTIC DELIVERY SYSTEM |
IHD, INC. |
MICHAEL D JOHNSON |
| K971252 |
07/06/1998 |
SEVRAIN CRANIAL CLAMP |
IKONOS CORP. |
CHARLES ALBERT |
| K981466 |
07/14/1998 |
XR-910 |
IMAGING SCIENCES INTL., INC. |
ROBERT E HAY |
| K981313 |
07/09/1998 |
SEQUENCER |
IMPAC MEDICAL SYSTEMS, INC. |
JAMES HOEY |
| K982302 |
07/31/1998 |
IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS |
IMPLEX CORP. |
JOHN S SCHALAGO |
| K981631 |
07/28/1998 |
INFLUENCE CLIP SYSTEM |
INFLUENCE, INC. |
JONATHAN S KAHAN |
| K981857 |
07/29/1998 |
QUANTA LITE TPO ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K981721 |
07/28/1998 |
C0-AXIAL INTRODUCER NEEDLE |
INRAD |
ANNE ARMSTRONG |
| K981641 |
07/17/1998 |
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ |
INSTRUMENTARIUM CORP. |
MAX LINDERT |
| K981479 |
07/07/1998 |
IL TEST PT-FIBRINOGEN RECOMBINANT |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K981534 |
07/23/1998 |
VIPERCAM |
INTEGRA MEDICAL |
W. EDWARD JOHANSEN |
| K982421 |
07/31/1998 |
IMAGYN 125 I SEED, MODEL IS 125 |
INTERNATIONAL ISOTOPES, INC. |
BETSY C KING |
| K981308 |
07/06/1998 |
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG |
INTERNATIONAL RESPIRATORY SYSTEMS, INC. |
E.J. Smith |
| K981307 |
07/06/1998 |
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR |
INTERNATIONAL RESPIRATORY SYSTEMS, INC. |
E.J. Smith |
| K974799 |
07/07/1998 |
HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE |
INTERNATIONAL TECHNIDYNE CORP. |
ROBERT MATLAND |
| K982368 |
07/31/1998 |
MANIFOLD WITH EXTENSION SET |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K981112 |
07/24/1998 |
MOBETRON |
INTRAOP MEDICAL, INC. |
DONALD A GOER |
| K980290 |
07/21/1998 |
ITI STENT |
INTRATHERAPEUTICS, INC. |
AMY PETERSON |
| K982232 |
07/25/1998 |
MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM |
IRVINE BIOMEDICAL, INC. |
ROGER TU |
| K981335 |
07/02/1998 |
ARISTON PHC LINER |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K981264 |
07/02/1998 |
ARISTON PHC |
IVOCLAR USA, INC. |
PETER P MANCUSO |
| K981247 |
07/01/1998 |
SILCAST (CODE NAME RD-0118) |
J.F. JELENKO & CO., INC. |
TRIDIB DASGUPTA |
| K980778 |
07/17/1998 |
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
DIANE MINEAR |
| K974739 |
07/01/1998 |
HAKIM PROGRAMMABLE VALVE SYSTEM |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
DIANE MINEAR |
| K981456 |
07/02/1998 |
BABY PACIFIER DIGITAL THERMOMETER |
K-JUMP HEALTH CO., LTD. |
ROBERT J ZAPPA |
| K981615 |
07/08/1998 |
KSEA UROPUMP |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K974415 |
07/10/1998 |
KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP |
KIMBERLY-CLARK CORP. |
LARRY R KLUDT |
| K981393 |
07/10/1998 |
MICROCOOL SURGICAL GOWN |
KIMBERLY-CLARK CORP. |
LARRY R KLUDT |
| K981251 |
07/02/1998 |
KYPHON INFLATABLE BONE TAMP |
KYPHON, INC. |
KAREN TALMADGE |
| K970712 |
07/21/1998 |
LAPARO-TENSER |
L & T S.N.C. DI E. LUCINI & C. |
FLAVIO LUCINI |
| K971322 |
07/22/1998 |
CORE AND COIL ASSEMBLY GUIDEWIRE |
LAKE REGION MFG., INC. |
KIM AVES |
| K981326 |
07/10/1998 |
LAKE REGION MANUFACTURING GUIDEWIRES |
LAKE REGION MFG., INC. |
KIM E AVES |
| K981235 |
07/15/1998 |
OCULOSTAT |
LASER CENTER DEV. CORP. |
FRANCIS E O'DONNELL |
| K972575 |
07/17/1998 |
800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES |
LASERSCOPE |
LISA MCGRATH |
| K981755 |
07/13/1998 |
LM ANCHOR |
LI MEDICAL TECHNOLOGIES, INC. |
RHODEMANN LI |
| K981764 |
07/13/1998 |
LM ANCHOR |
LI MEDICAL TECHNOLOGIES, INC. |
RHODEMANN LI |
| K981637 |
07/20/1998 |
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY |
LINVATEC CORP. |
CAROL A WEIDEMAN |
| K981692 |
07/27/1998 |
MENISCAL REPAIR DEVICE |
LINVATEC CORP. |
CAROL A WEIDEMAN |
| K980719 |
07/31/1998 |
CALM |
LMS MEDICAL SYSTEMS LTD. |
DR. EMILY HAMILTON |
| K981531 |
07/13/1998 |
SUTURE PLACEMENT DEVICE AND ACCESSORIES |
LSI SOLUTIONS |
JUDE S SAUER |
| K980771 |
07/13/1998 |
LYSONIX SUCTION LIPOPLASTY SYSTEM |
LYSONIX, INC. |
RONALD F LAGERQUIST |
| K981951 |
07/28/1998 |
CT 100 ELECTROCARDIOGRAPH |
MACQUARIE MEDICAL SYSTEMS |
FRANK FERGUSON |
| K981310 |
07/09/1998 |
MAGNATEK C-300 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
ANNIE VELEZ |
| K980536 |
07/31/1998 |
EPIDURAL NEEDLE |
MANAN MEDICAL PRODUCTS, INC. |
MICHAEL PLISHKA |
| K981071 |
07/23/1998 |
ML MICROKERATOME |
MED-LOGICS, INC. |
BETTY ROSS |
| K980990 |
07/31/1998 |
POLYCARBOXYLATE CEMENT |
MEDENTAL INTL. |
DEBRA OLSON |
| K982123 |
07/21/1998 |
CONTRAST CONTROL DEVICE |
MEDEX, INC. |
CINDY CHENETSKI |
| K982085 |
07/17/1998 |
MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K982047 |
07/21/1998 |
MPS HUBER NEEDLE EXTENSION SET |
MEDICAL PRODUCT SPECIALISTS |
DAN HYUN |
| K982048 |
07/27/1998 |
MPS RESERVOIR BAG |
MEDICAL PRODUCT SPECIALISTS |
DAN HYUN |
| K981509 |
07/10/1998 |
TEMPO III |
MEDICAL PRODUCTS, INC. |
DURWARD FARIES, JR. |
| K981598 |
07/01/1998 |
HERNIA MESH STABILIZER |
MEDIVICES CO. |
JOHN BELKNAP |
| K981511 |
07/24/1998 |
OTO WIZZARD |
MEDRX, INC. |
JEFFREY A MCLAUGHLIN |
| K982211 |
07/29/1998 |
PROFILE-II MODEL 600582 |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
| K981815 |
07/30/1998 |
HEPTRAC ELECTRONIC QUALITY CONTROL |
MEDTRONIC BLOOD MANAGEMENT |
JOYCE THOMAS |
| K981527 |
07/09/1998 |
MENTOR PATHWAY INTRODUCER/DILATOR |
MENTOR CORP. |
DONNA A CRAWFORD |
| K981417 |
07/17/1998 |
Squirt Fluid Delivery System |
MERIT MEDICAL SYSTEMS, INC. |
DENNIS D REIGLE |
| K981266 |
07/14/1998 |
AUTO-INJECTOR, SURE-INJECT 2000 |
MIGHTY MO, CORP. |
JOHN D'ANGELO |
| K973363 |
07/02/1998 |
NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 |
ML STRATEGIES, INC. |
ALLAN M GREEN |
| K981741 |
07/24/1998 |
CARRIAZO BARRAQUER MICROKERATOME |
MORIA, INC. |
ALAIN DUPRAT |
| K981837 |
07/09/1998 |
TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS |
MOTION CONCEPTS |
DAVID HARDING |
| K980365 |
07/22/1998 |
GOODKNIGHT 418 CPAP SYSTEM |
NELLCOR PURITAN BENNETT, INC. |
STEPHEN THEISSEN |
| K981828 |
07/07/1998 |
GALILEO DISPOSABLE HYSTEROSCOPES |
NETOPTIX CORP. |
MARY MCNAMARA-CULLINANE, RAC |
| K980040 |
07/13/1998 |
ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D |
NISHA COMMUNICATION INDUSTRIES |
NISHA JOHARI |
| K981730 |
07/17/1998 |
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 |
NK BIOTECHNICAL CORP. |
KAREN GOTFREDSON |
| K981424 |
07/17/1998 |
NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM |
NOMOS CORP. |
MARVIN L SUSSMAN |
| K982277 |
07/22/1998 |
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991) |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K974428 |
07/30/1998 |
DIPSTREAK |
NOVAMED LTD. |
GERALD M SLUTZKY |
| K974748 |
07/10/1998 |
NEUROMETRIC ANALYSIS SYSTEM |
NXLINK, LTD. |
DUANE SHUTTLESWORTH |
| K981488 |
07/07/1998 |
GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION |
OAK CAROLINA, INC. |
DARRELL W ALFORD |
| K981963 |
07/24/1998 |
SENSITEX EXAMINATION GLOVE |
OAK CAROLINA, INC. |
DARRELL ALFORD |
| K971340 |
07/29/1998 |
OLYMPUS NEURO ENDOSCOPE |
OLYMPUS OPTICAL, CO. |
SUSAN D GOLDSTEIN-FALK |
| K981464 |
07/10/1998 |
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE |
OMNITECH SYSTEMS, INC. |
JON D BARRETT |
| K981463 |
07/17/1998 |
OMNITECH RESECTOSCOPE ROLLER ELECTRODE |
OMNITECH SYSTEMS, INC. |
JON D BARRETT |
| K974200 |
07/21/1998 |
ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM |
ORCA DIAGNOSTICS CORP. |
SHEILA W PICKERING |
| K981736 |
07/24/1998 |
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K981315 |
07/09/1998 |
NAVITRACK |
ORTHOSOFT, INC. |
NICOLE LANDREVILLE |
| K982032 |
07/09/1998 |
OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS |
OSTEONICS CORP. |
KATE SUTTON |
| K981405 |
07/16/1998 |
SYNERGY LT |
OXFORD INSTRUMENTS, PLC. |
JEFF HALL |
| K971084 |
07/21/1998 |
MODEL 02 OXYGEN ANALYZER |
OXIGRAF, INC. |
BRUCE MCCAUL |
| K972913 |
07/30/1998 |
MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM) |
PACIFIC MATERIALS AND INTERFACES |
FLOYD G LARSON |
| K980517 |
07/21/1998 |
EPILASER NORMAL MODE RUBY LASER |
PALOMAR MEDICAL PRODUCTS, INC. |
Marcy Moore |
| K982235 |
07/30/1998 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA DILLON |
| K982156 |
07/29/1998 |
PASCO MIC AND MIC/ID PANELS/ CEFDINIR |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K980526 |
07/27/1998 |
PHOTON RADIOSURGERY SYSTEM PRS400 |
PEC PHOTOELECTRON CORP. |
THOMAS R VARRICCHIONE |
| K974868 |
07/02/1998 |
SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER |
PERRY BAROMEDICAL CORP. |
JAMES P DODSON |
| K981559 |
07/07/1998 |
UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K981930 |
07/07/1998 |
UNICAP THYROID PEROXIDASE IGG |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K981406 |
07/16/1998 |
CERVIX COIL LATEX SHEATH |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K981959 |
07/31/1998 |
OUTLOOK LARGE PHASED ARRAY NECK COIL |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K982203 |
07/14/1998 |
CAAS II LVA BIPLANE OPTION |
PIE MEDICAL EQUIPMENT B.V. |
FRANK ANIBA |
| K980066 |
07/16/1998 |
CPR FILTERSHIELD |
PLASCO, INC. |
GARY S BOTSFORD |
| K981760 |
07/22/1998 |
PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598 |
PLAYTIME PRODUCTS, INC. |
MARK ROSENGARTEN |
| K981978 |
07/22/1998 |
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS, JR. |
| K981493 |
07/22/1998 |
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K981374 |
07/02/1998 |
POREX NOSTRIL RETAINERS |
POREX SURGICAL, INC. |
HOWARD A MERCER |
| K974586 |
07/15/1998 |
AURORA DIODE LASER SYSTEM |
PREMIER LASER SYSTEMS, INC. |
LISA MOJICA |
| K974655 |
07/09/1998 |
PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM |
PREP TECHNOLOGY CORP. |
JOE W SHAFFER |
| K980087 |
07/01/1998 |
PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330 |
PRESSURE PRODUCTS, INC. |
JAMES BARLEY |
| K981444 |
07/22/1998 |
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K981882 |
07/06/1998 |
CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K980212 |
07/09/1998 |
MITYVAC |
PRISM TECHNOLOGIES, INC. |
HOWARD M HOLSTEIN, ESQ. |
| K982293 |
07/13/1998 |
PRESSURE TRANSDUCER AIRFLOW SENSOR |
PRO-TECH SERVICES, INC. |
ANTHONY ZARAGOZA |
| K972255 |
07/07/1998 |
PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM |
PULSE BIOMEDICAL, INC. |
SALEEM HASAN |
| K973004 |
07/16/1998 |
KNIGHTSTAR 335 |
PURITAN BENNETT CORP. |
C. MARSHALL SMITH |
| K981774 |
07/24/1998 |
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE |
PWA INDUSTRIES SDN. BHD. |
AZMAN ISMAIL |
| K974111 |
07/29/1998 |
QUIDEL CH50 EQ EIA |
QUIDEL CORP. |
Robin Weiner |
| K982231 |
07/20/1998 |
STATUSFLOW |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
| K981213 |
07/01/1998 |
UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I |
RADIONICS, INC. |
LISA M BENATI |
| K981672 |
07/17/1998 |
RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR |
RADIOTHERAPEUTICS CORP. |
COLIN J NICHOLS |
| K982341 |
07/30/1998 |
DIRECT HDL-CHOLESTROL LIQUID |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
| K980522 |
07/22/1998 |
REFRACTEC MCS-100 |
REFRACTEC, INC. |
MITCH CAMPBELL |
| K981391 |
07/14/1998 |
PAR-ONE |
REMEL, INC. |
MARY ANN SILVIUS |
| K981321 |
07/07/1998 |
BIPOLAR FORCEPS SET (MODULAR) |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K980302 |
07/20/1998 |
WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K981558 |
07/09/1998 |
MYCYCLE HANDMASTER, LIGHT |
RICHVALE LTD. |
SUSAN MAYS |
| K981557 |
07/09/1998 |
MYCYCLE, HANDMASTER, VICTORY |
RICHVALE LTD. |
SUSAN MAYS |
| K981612 |
07/08/1998 |
ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER |
ROCHESTER MEDICAL CORP. |
MARY WILEN |
| K972908 |
07/22/1998 |
SANDS SERIES III HYPERBARIC CHAMBER |
SANDS HYPERBARICS |
LACHLAN SANDS |
| K982217 |
07/02/1998 |
AC/AD LINEARITY VERIFIERS |
SC CALIBRATORS & CONTROLS LLC. |
ROY F SCHALL, JR |
| K982028 |
07/14/1998 |
FLUOROSPOT COMPACT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MALGORZATA STANEK |
| K982502 |
07/31/1998 |
GENESIS IMRT LINEAR ACCELERATOR |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHRYN B DODD |
| K982513 |
07/31/1998 |
MX MEVATRON |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHRYN B DODD |
| K974698 |
07/08/1998 |
SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JACQUELINE E. M EMERY |
| K981850 |
07/09/1998 |
SILIMED CHIN IMPLANTS |
SILIMED, LLC. |
E.J. Smith |
| K981835 |
07/09/1998 |
SILIMED MALAR IMPLANT |
SILIMED, LLC. |
E.J. Smith |
| K981851 |
07/09/1998 |
SILIMED SILICONE CARVING BLOCK |
SILIMED, LLC. |
E.J. Smith |
| K982049 |
07/14/1998 |
BIOPSY M |
SITCO, INC. |
ROBERT H MCCARTHY |
| K981847 |
07/17/1998 |
BIOLOX ALUMINA CERAMIC FEMORAL HEAD |
SMITH & NEPHEW, INC. |
JOANN KUHNE |
| K981713 |
07/31/1998 |
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0 |
SMITH & NEPHEW, INC. |
JIM G IRVIN |
| K981529 |
07/09/1998 |
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW |
SMITH & NEPHEW, INC. |
JOANN KUHNE |
| K982067 |
07/13/1998 |
MAGNETIC PORT SILICONE TISSUE EXPANDER |
SPECIALTY SURGICAL PRODUCTS, INC. |
T. JAN VARNER |
| K980288 |
07/29/1998 |
SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM |
SPINE-TECH, INC. |
DAVID A CANNISTRACI |
| K973347 |
07/23/1998 |
TSX PRM PULMONARY RESUSCITATION MONITOR |
SPIRACLE TECHNOLOGY |
GUY GANSEL |
| K982351 |
07/29/1998 |
LUNA |
STELLATE SYSTEMS |
GEORGE PAPAGIANNIS |
| K980158 |
07/28/1998 |
MYO-TRAIN V (5) |
STERNE EQUIPMENT CO., LTD. |
THOMAS WALLACE |
| K982290 |
07/22/1998 |
CHEM-CHEX STAT (NEW) |
STRECK LABORATORIES, INC. |
PAUL KITTELSON |
| K981562 |
07/30/1998 |
SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT |
SULZER CALCITEK, INC. |
FOSTER BOOP |
| K981602 |
07/17/1998 |
DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR |
SUNRISE MEDICAL HHG, INC. |
ALLAN R JONES |
| K981745 |
07/17/1998 |
BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX |
SUNSCOPE INTL., INC. |
JOHN SHULZE |
| K980966 |
07/22/1998 |
SUPERGLOVES POWDERED NITRILE |
SUPERMAX SDN BHD |
STANLEY THAI |
| K981346 |
07/10/1998 |
RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
| K980849 |
07/09/1998 |
SURGIN KIT |
SURGIN SURGICAL INSTRUMENTATION, INC. |
DON HAAR |
| K982148 |
07/31/1998 |
PRODIGY 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K981757 |
07/17/1998 |
SYNTHES (USA) DHS HELIX SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K982222 |
07/29/1998 |
SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K974025 |
07/06/1998 |
ANSPACH SHIELDED ATTACHMENT |
THE ANSPACH EFFORT, INC. |
WILLIAM E ANSPACH III |
| K981688 |
07/13/1998 |
ANSPACH SUTURE ANCHOR |
THE ANSPACH EFFORT, INC. |
WILLIAM E ANSPACH, III |
| K981030 |
07/20/1998 |
BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981029 |
07/20/1998 |
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K974040 |
07/14/1998 |
C3 EXTERNAL MALE BLADDER CONTROL DEVICE |
TIMM RESEARCH CO. |
DAVID ANDERSON |
| K981397 |
07/31/1998 |
HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K981475 |
07/14/1998 |
OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE |
TOSHIBA AMERICA MRI, INC. |
BRUCE E CLARK |
| K980538 |
07/09/1998 |
LASER LANCET LB100 |
TRANSMEDICA INTL., INC. |
Kevin Marchitto |
| K981078 |
07/23/1998 |
TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 |
TRANSTRACHEAL SYSTEMS |
LEWIS WARD |
| K981441 |
07/10/1998 |
HEART CATH TRAY, STERILE, DISPOSABLE |
TRINITY LABORATORIES, INC. |
PARTHA BASUMALLIK |
| K981596 |
07/31/1998 |
ULTRAPAK E |
ULTRADENT PRODUCTS, INC. |
CHESTER MCCOY |
| K973154 |
07/22/1998 |
UBI MAGIWEL MARIJUANA METABOLITES |
UNITED BIOTECH, INC. |
WUAN T LU |
| K972328 |
07/07/1998 |
PERCUTANEOUS BREAST BIOPSY (PBB) |
UROTHEALTH SYSTEM, INC. |
JULIE POWELL |
| K972750 |
07/09/1998 |
TAKA ANEURYSM CLIP |
V. MUELLER NEURO/SPINE |
TERRY JOHNSTON |
| K981262 |
07/06/1998 |
CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
VALLEYLAB, INC. |
JULIE ROSS |
| K981683 |
07/28/1998 |
HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y |
VENUSA LTD. |
NEIL KULKARNI |
| K974707 |
07/31/1998 |
IMAGEQUEST |
VISUAL MED, INC. |
|
| K981789 |
07/13/1998 |
LORENZ PECTUS SUPPORT BAR STABILIZER |
WALTER LORENZ SURGICAL, INC. |
DIANE PRESTON |
| K981748 |
07/22/1998 |
WIELISA ANCA SCREENING KIT TEST SYSTEM |
WIESLAB AB |
WILLIAM L BOTELER, JR. |
| K981750 |
07/22/1998 |
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM |
WIESLAB AB |
WILLIAM L BOTELER JR. |
| K981889 |
07/31/1998 |
WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
GARY A LAMOUREUX |
| K981350 |
07/09/1998 |
ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES |
XINTEC CORPORATION |
MARILYN M CHOU |
| K981627 |
07/31/1998 |
PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) |
XINTEC CORPORATION |
MARILYN M CHOU |
| K980821 |
07/30/1998 |
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
