FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K010183 |
05/02/2001 |
GLOBAL BY BLASTOCYST MEDIA |
INTL., INC. |
MICHAEL D CECCHI |
K011167 |
05/17/2001 |
XSE |
3M COMPANY |
KAREN O'MALLEY |
K010510 |
05/16/2001 |
BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 |
A & A MEDICAL, INC. |
JIHAD (JAY) MANSOUR |
K011096 |
05/01/2001 |
ABBOTT ACCLAIM ENCORE, MODEL 12237 |
ABBOTT LABORATORIES |
FRANK POKROP |
K011217 |
05/16/2001 |
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT |
ABBOTT LABORATORIES |
THOMAS P SAMPOGNA |
K010582 |
05/07/2001 |
ACON STREP A RAPID TEST STRIP |
ACON LABORATORIES CO. |
ROBERT HUDAK |
K010587 |
05/16/2001 |
ACTIVEECG |
ACTIVE CORP. |
KAREN SIEGEL |
K010711 |
05/22/2001 |
ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR |
ADVANCED SURGICAL CONCEPTS (ASC) |
MARY MCNAMARA-CULLINANE |
K011224 |
05/04/2001 |
HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
TERRENCE J SWEENEY |
K001807 |
05/03/2001 |
TISSUE MARKER |
ADVANCED UROSCIENCE, INC. |
KAREN E PETERSON |
K002824 |
05/08/2001 |
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM |
AESCULAP, INC. |
DAVID W SCHLERF |
K003978 |
05/22/2001 |
AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007 |
AFX, INC. |
NANCY NORRIS |
K011093 |
05/01/2001 |
AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 |
AGILENT TECHNOLOGIES, INC. |
DAVE OSBORN |
K003819 |
05/02/2001 |
HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A |
AGILENT TECHNOLOGIES, INC. |
TERESA SKARR |
K010125 |
05/29/2001 |
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K003647 |
05/29/2001 |
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K003881 |
05/29/2001 |
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K003879 |
05/29/2001 |
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) |
ALFA SCIENTIFIC DESIGNS, INC. |
NAIISHU WANG |
K010015 |
05/29/2001 |
INSTANT-VIEW METHADONE URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K010014 |
05/29/2001 |
INSTANT-VIEW METHADONE URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K010080 |
05/29/2001 |
INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K010079 |
05/29/2001 |
INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K010047 |
05/29/2001 |
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K010045 |
05/29/2001 |
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K003845 |
05/29/2001 |
MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K003847 |
05/29/2001 |
MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K011186 |
05/25/2001 |
POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
K011457 |
05/23/2001 |
ALOKA SSD-5500 WITH KI AND A-SMA |
ALOKA CO., LTD. |
KELVIN BURROUGHS |
K011314 |
05/15/2001 |
OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
KELVIN BURROUGHS |
K011315 |
05/15/2001 |
SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5 |
ALOKA CO., LTD. |
KELVIN BURROUGHS |
K010583 |
05/25/2001 |
AMBU GEL, HYDROGEL BURN DRESSING |
AMBU, INC. |
SANJAY PARIKH |
K011415 |
05/30/2001 |
ALPCO MILENIA ANTI-TG EIA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD E CONLEY |
K011201 |
05/24/2001 |
ALPCO MILENIA ANTI-TPO ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD E CONLEY |
K010605 |
05/07/2001 |
ATLAST DATA MANAGEMENT SOFTWARE (DMS) |
AMIRA MEDICAL, INC. |
NINA PELED |
K011006 |
05/11/2001 |
AMYSEAT TILT/RECLINE SEATING |
AMYSYSTEMS |
SYLVAIN DUGAS |
K011304 |
05/29/2001 |
OB-1 FETAL MONITOR |
ANALOGIC CORP. |
STEVEN A CLARKE |
K011077 |
05/09/2001 |
ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22) |
ANDERSEN PRODUCTS, INC. |
WENDY HEDRICK |
K010961 |
05/31/2001 |
X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
ANSELL HEALTHCARE PRODUCTS, INC. |
JAMES R CHATTERTON |
K011233 |
05/18/2001 |
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 |
APEX BIOTECHNOLOGY CORP. |
BRUCE A MACFARLANE |
K003871 |
05/31/2001 |
LAPAROSCOPIC HAND PORT |
APPLIED MEDICAL RESOURCES CORP. |
ANIL BHALANI |
K011236 |
05/14/2001 |
MODIFICATION TO IMPLANTABLE CLIP |
APPLIED MEDICAL RESOURCES CORP. |
ANIL BHALANI |
K002256 |
05/03/2001 |
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP |
ARROW INTL., INC. |
WILLIAM PAQUIN |
K010673 |
05/14/2001 |
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 |
ARTHREX, INC. |
BRETTE MASINO |
K010525 |
05/23/2001 |
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM |
ARTHREX, INC. |
VERNON BROWN |
K010457 |
05/14/2001 |
ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924 |
ARTHREX, INC. |
VERNON BROWN |
K010811 |
05/30/2001 |
PERC-D SPINEWAND |
ARTHROCARE CORP. |
BRUCE PROTHRO |
K010517 |
05/18/2001 |
ADVANTA SST GRAFT (<6MM) |
ATRIUM MEDICAL CORP. |
KAREN HALL |
K010516 |
05/18/2001 |
ADVANTA SST GRAFT (>_6MM) |
ATRIUM MEDICAL CORP. |
KAREN HALL |
K003187 |
05/21/2001 |
VACUCATH I.V. CATHETER INTRODUCTER |
AUTO/CATH VASCULAR ACCESS, INC. |
ANIL BHALANI |
K003033 |
05/30/2001 |
SCAPHIX, STAPLE, FIXATION, BONE |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
K010877 |
05/23/2001 |
CHEMWELL, MODEL 2900 |
AWARENESS TECHNOLOGY, INC. |
MARY FREEMAN |
K010292 |
05/01/2001 |
DRX 2000 |
AXIOM WORLDWIDE, INC. |
JIM GIBSON |
K010485 |
05/18/2001 |
VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER |
B BRAUN |
PAUL O'CONNELL |
K010566 |
05/15/2001 |
COLLEAGUE VOLUMETRIC INFUSION PUMP |
BAXTER HEALTHCARE CORP. |
JENNIFER M PAINE |
K002565 |
05/03/2001 |
BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE) |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
K011177 |
05/23/2001 |
BCI ADVISOR VITAL SIGNS MONITOR (9200) |
BCI, INC. |
DONALD J ALEXANDER |
K010696 |
05/10/2001 |
BECKMAN COULTER DNASE B CALIBRATOR |
BECKMAN COULTER, INC. |
RICHARD T ROSS |
K011213 |
05/16/2001 |
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
K010597 |
05/29/2001 |
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
K010947 |
05/25/2001 |
SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
BEIJING REAGENT LATEX PRODUCTS CO., LTD. |
CHRISTINA SMITH |
K003480 |
05/11/2001 |
BIOFIND |
BIO-SCAN, INC. |
BUTCH SMITH |
K010458 |
05/10/2001 |
THE MAESTRO SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
STEVEN BOGGAN |
K010689 |
05/18/2001 |
MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM |
BIOLITEC, INC. |
CAROL J MORELLO |
K011219 |
05/18/2001 |
ASCENT KNEE SYSTEM |
BIOMET, INC. |
DALENE T BINKLEY |
K011237 |
05/23/2001 |
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS |
BIOMET, INC. |
DALENE T BINKLEY |
K010348 |
05/03/2001 |
TANTALUM BEADS - RADIOGRAPHIC MARKER |
BIOMET, INC. |
LONNIE WITHAM |
K010554 |
05/25/2001 |
MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A |
BIONX IMPLANTS, INC. |
TUIJA ANNALA |
K011380 |
05/14/2001 |
MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM |
BIOPLATE, INC. |
CAROL E JONES |
K011104 |
05/31/2001 |
OSTEOBELL |
BIOPSYBELL S.A.S. |
LUCIO IMPROTA |
K003105 |
05/22/2001 |
BIOSPHERE MEDICAL INFUSION CATHETER |
BIOSPHERE MEDICAL |
JOHN BONASERA |
K003735 |
05/08/2001 |
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR |
BLACKSTONE MEDICAL, INC. |
ALAN LOMBARDO |
K003251 |
05/23/2001 |
BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 |
BLEASE MEDICAL EQUIPMENT LTD. |
ART WARD |
K010479 |
05/08/2001 |
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR |
BONUTTI RESEARCH, INC. |
PATRICK BALSMANN |
K003589 |
05/21/2001 |
VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT |
BRAINLAB AG |
STEFAN VILSMEIER |
K003732 |
05/16/2001 |
BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES |
BRAUN GMBH |
FRED SCHLADOR |
K003828 |
05/18/2001 |
VASO PRESS DVT FOOT GARMENT #VP 520 |
BRITT CORP., INC. |
J J BRITTON |
K011267 |
05/08/2001 |
EXHALE RF PROBE |
BRONCUS TECHNOLOGIES, INC. |
TIM R WILLIAMS |
K011227 |
05/11/2001 |
REGAL MOTOTRIZED 3 WHEELED VEHICLE |
BRUNO INDEPENDENT LIVING AIDS, INC. |
RICHARD A KELLER |
K002514 |
05/31/2001 |
CADHEALTH SYSTEM, MODEL CHP-001 |
CADUCEUS HEALTH CARE LTD. |
BARRY MARTIN |
K011324 |
05/23/2001 |
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
K010915 |
05/21/2001 |
CDMX |
CAMSIGHT CO., INC. |
JAY CHOI |
K010552 |
05/11/2001 |
CG-900P FETAL/MATERNAL MONITOR |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
LEONID TRACHTENBERG |
K003707 |
05/16/2001 |
CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A |
CARDIONET |
DONALD CANAL |
K003020 |
05/11/2001 |
CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER |
CD LEYCOM BV |
TIM LENIHAN |
K010244 |
05/02/2001 |
SURE CHECK OVULATION PREDICTOR |
Chembio Diagnostic Systems, Inc. |
FRAN WHITE |
K003458 |
05/03/2001 |
SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 |
CLINICAL INNOVATIONS, INC. |
DEAN WALLACE |
K010680 |
05/23/2001 |
CT SPACER |
CLINICAL TECHNOLOGIES, INC. |
BOB JOHNSON |
K003084 |
05/16/2001 |
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 |
CONCENTRIC MEDICAL, INC. |
LINDA BRADLEY |
K003086 |
05/16/2001 |
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008 |
CONCENTRIC MEDICAL, INC. |
LINDA BRADLY |
K003410 |
05/22/2001 |
CONCENTRIC RETRIEVER, MODEL 90030 |
CONCENTRIC MEDICAL, INC. |
SAM LAZZARA |
K003880 |
05/16/2001 |
CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) |
CONCENTRIC MEDICAL, INC. |
SAM LAZZARA |
K011012 |
05/01/2001 |
POWDER FREE NITRILE EXAMINATION GLOVE |
CONTRACT LATEX DIPPERS SDN BHD |
VINAYAGAN RAMALINGAM |
K011157 |
05/03/2001 |
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT |
COOK UROLOGICAL, INC. |
BRENDA DAVIS |
K010316 |
05/01/2001 |
COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM |
COOLTOUCH CORP. |
DONALD V JOHNSON |
K010494 |
05/01/2001 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
DADE BEHRING, INC. |
RADAMES RIESGO |
K010395 |
05/11/2001 |
E-POWER |
DALTON MEDICAL CORP. |
WILL RIDGWAY |
K003630 |
05/29/2001 |
DANMAR PRODUCTS MICHIGAN CRANIAL HELMET |
DANMAR PRODUCTS, INC. |
KAREN A LINDNER |
K011009 |
05/02/2001 |
WHITE MTA MATERIAL |
DENTSPLY INTERNATIONAL |
P.JEFFERY LEHN |
K011182 |
05/16/2001 |
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS |
DEPUY ACROMED |
LISA GILMAN |
K010576 |
05/23/2001 |
MONARCH SPINE SYSTEM |
DEPUY ACROMED |
FRANK MAAS |
K003043 |
05/08/2001 |
SURGICAL TITANIUM MESH SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
K010958 |
05/18/2001 |
FISTULOK FISTULA NEEDLE PROTECTION |
DIASOL, INC. |
MONICA ABELES |
K011004 |
05/24/2001 |
NEEDLELOK HYPODERMIC NEEDLE PROTECTION |
DIASOL, INC. |
MONICA ABELES |
K010595 |
05/08/2001 |
DJ ORTHOPEDICS INTERFERENCE SCREW |
DJ ORTHOPEDICS, LLC |
JAMAL D RUSHDY |
K010594 |
05/29/2001 |
DJ ORTHOPEDICS POST SCREW |
DJ ORTHOPEDICS, LLC |
JAMAL D RUSHDY |
K010565 |
05/15/2001 |
DYNATRON STS |
DYNATRONICS CORP. |
JOHN S RAMEY |
K010948 |
05/15/2001 |
DYNATRON STS RX |
DYNATRONICS CORP. |
JOHN S RAMEY |
K011160 |
05/16/2001 |
E-Z EM PERCUPUMP 2001 CT INJECTOR |
E-Z-EM, INC. |
BOB WILLIAMS |
K010551 |
05/17/2001 |
EBI DYNAFIX VS OSTEOTOMY SYSTEM |
EBI, L.P. |
PATRICIA FLOOD |
K002817 |
05/02/2001 |
SYNETEC |
ELA MEDICAL, INC. |
SUSAN OLIVE |
K003442 |
05/04/2001 |
MODIFICATION TO EDI VERIS SYSTEM |
ELECTRO-DIAGNOSTIC IMAGING, INC. |
SHEILA W PICKERING |
K010465 |
05/14/2001 |
DENSTAT |
ELMED, INC. |
WERNER HAUSNER |
K003528 |
05/03/2001 |
SANARUS CORE TISSUE BIOPSY SYSTEM |
ENDOCARE, INC. |
VINCENT CUTARELLI |
K002848 |
05/24/2001 |
SPO2 WRAP SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
KRISTA OAKES |
K011154 |
05/16/2001 |
ELIPAR FREELIGHT |
ESPE DENTAL AG |
ANDREAS PETERMANN |
K010898 |
05/31/2001 |
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145 |
ETHICON ENDO-SURGERY, INC. |
RUTH ANN WOOD |
K011218 |
05/16/2001 |
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1 |
EXACTECH, INC. |
GARY J MILLER |
K010197 |
05/14/2001 |
EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET |
EXELINT INTERNATIONAL CO. |
ARMAND HAMID |
K003122 |
05/14/2001 |
SMARTFLOW, MODEL SFIP 2000 |
FLORENCE MEDICAL LTD. |
SHOSHANA FREIDMAN, RAC |
K010991 |
05/03/2001 |
SEEDNET, MODELS FP6T5, FP5T5, FP5T3 |
GALIL MEDICAL LTD. |
JOHATHAN S KAHAN |
K011188 |
05/18/2001 |
GE LOGIQ 9, MODEL 2188900-X |
GE MEDICAL SYSTEMS |
ALLEN SCHUH |
K003395 |
05/21/2001 |
GEN-PROBE APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
E. JOSEPH MCMULLEN |
K011153 |
05/29/2001 |
ALANTE, BATTERY OPERATED POWER WHEELCHAIR |
GOLDEN TECHNOLOGIES, INC. |
FRED KIWAK |
K010763 |
05/25/2001 |
GOODNET |
GOODMAN CO.,LTD. |
DOUGLAS F ORR |
K010675 |
05/30/2001 |
ENSIL FABRIC |
GOTTFRIED MEDICAL, INC. |
BRENT M GOTTFRIED |
K010672 |
05/18/2001 |
MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE |
GRAMSMED LLC |
ANTHONY J DIMERCURIO |
K001694 |
05/15/2001 |
GUIDANT RETRIEVER DEVICE |
GUIDANT CARDIAC AND VASCULAR SURGERY |
BERNICE JURS |
K011039 |
05/08/2001 |
OMNILINK .018 BILIARY STENT SYSTEM |
GUIDANT CORP. |
CURTIS TRUESDALE |
K011385 |
05/18/2001 |
HARDKYDISK NEOMYCIN, 30 MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR, RAC |
K011115 |
05/02/2001 |
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
DAGMAR MASER |
K010864 |
05/21/2001 |
ANALYST PANELS + ANALYTICAL TEST ROTOR |
HEMAGEN DIAGNOSTICS, INC. |
JOSE A MONTANEZ |
K011126 |
05/02/2001 |
RAICHEM CREATININE URINE STANDARD |
HEMAGEN DIAGNOSTICS, INC. |
JOSE A MONTANEZ |
K011036 |
05/10/2001 |
RD-3008 |
HERAEUS KULZER, INC. |
RAPHAEL JUDKINS |
K010800 |
05/31/2001 |
VERSYO.COM |
HERAEUS KULZER, INC. |
RAPHAEL JUDKINS |
K011412 |
05/31/2001 |
POWDER-FREE VINYL EXAM GLOVES |
HEYUAN HONGLI INDUSTRIES, INC. |
JANNA P TUCKER |
K003405 |
05/07/2001 |
ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO |
HIGHLAND / MARIETTA, INC. |
JOHN NIKSA |
K003403 |
05/07/2001 |
ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 |
HIGHLAND / MARIETTA, INC. |
JOHN NIKSA |
K011252 |
05/30/2001 |
EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM |
HITACHI MEDICAL CORP. |
WALTER WEYBURNE |
K010448 |
05/16/2001 |
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES |
HORIZONS INTL. CORP. |
RAFIC SALEH |
K011136 |
05/04/2001 |
APEX FIXATION PINS |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K002186 |
05/02/2001 |
VASCULAR ASSIST |
HUNTLEIGH HEALTHCARE, INC. |
AUDREY A WITKO |
K010803 |
05/11/2001 |
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR |
HWA TEH INDUSTRIAL SDN. BHD. |
ABDUL HALIM ARSHAD |
K010858 |
05/24/2001 |
VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION |
ID BIOMEDICAL CORP. |
DAVID CLARY |
K003754 |
05/10/2001 |
IMMUNETICS C6 LYME ELISA KIT |
IMMUNETICS, INC. |
ANDREW E LEVIN |
K004012 |
05/14/2001 |
IMPRA CARBOFLO EPTFE VASCULAR GRAFTS |
IMPRA, INC. |
LORRI CHAVEZ |
K010533 |
05/24/2001 |
BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH |
INJECTX, INC. |
ASHVIN DESAI |
K000733 |
05/21/2001 |
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K010520 |
05/07/2001 |
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS |
INSTRUMENTATION LABORATORY CO. |
REBA POIRIER |
K011169 |
05/18/2001 |
HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 |
INTERNATIONAL ENZYMES, INC. |
CAROL RUGGIERO |
K011002 |
05/30/2001 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 |
INTUITIVE SURGICAL, INC. |
DAVID CASAL |
K010867 |
05/03/2001 |
KILEJIAN CIRCUMCISOR |
IRIS SURGICAL, LLC |
V. JOHN KILEJIAN |
K011022 |
05/02/2001 |
BIOUNIVERSAL PDF |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
K011023 |
05/02/2001 |
D.SIGN 96 |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
K011362 |
05/29/2001 |
GOLD CORE 73 LS |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
K002948 |
05/18/2001 |
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K011079 |
05/16/2001 |
K-ASSAY HS-CRP CONTROLS |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K010346 |
05/02/2001 |
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
K010543 |
05/23/2001 |
KM-30 TENS ELECTRODE |
KATECHO, INC. |
WARREN R WALTERS |
K010101 |
05/17/2001 |
GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM |
KINAMED, INC. |
VINEET SARIN |
K010863 |
05/03/2001 |
LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
K011084 |
05/10/2001 |
MANDREL GUIDEWIRE ASSEMBLY |
LAKE REGION MFG., INC. |
JIM KLOSTERMAN |
K010284 |
05/01/2001 |
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) |
LASERSCOPE |
PAUL H HARDIMAN |
K010834 |
05/21/2001 |
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES |
LASERSCOPE |
PAUL H HARDIMAN |
K002037 |
05/16/2001 |
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS |
LIFECORE BIOMEDICAL, INC. |
CAROLYN ANDERSON |
K010464 |
05/17/2001 |
RADCALC, MODEL V.4.0 |
LIFELINE SOFTWARE, INC. |
CRAIG A LAUGHTON |
K010460 |
05/14/2001 |
LIFELINES TRACKIT |
LIFELINES LTD. |
CRHISTINA SMITH |
K001699 |
05/15/2001 |
RUBICON PROTHROMBIN TIME MONITORING SYSTEM |
LIFESCAN, INC. |
JOHN E HUGHES |
K003943 |
05/04/2001 |
MICROGAS 7650 TRANSCUTANEOUS MONITOR |
LINDE MEDICAL SENSORS AG |
JEAN-PIERRE PALMA |
K002334 |
05/02/2001 |
MACROPORENS CRANILOC |
MACROPORE BIOSURGERY, INC. |
KENNITH K KLEINHENZ |
K010513 |
05/21/2001 |
CARDIAC VIEW, MODEL 2001 |
MAGNA-LAB, INC. |
LYNN CARTER |
K010695 |
05/03/2001 |
KOALA CLAMP |
MATERNUS, INC. |
RONALD B HICKS |
K002847 |
05/31/2001 |
INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX |
MAXXIM MEDICAL |
GAIL DOHERTY |
K011198 |
05/17/2001 |
SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL |
MAXXIM MEDICAL, INC. |
JAMAL S ALNASER |
K011246 |
05/23/2001 |
DCM 1.0 |
MDS NORDION |
E.S. MARTELL |
K002763 |
05/04/2001 |
REMREST |
MEDICAL INDUSTRIES AMERICA, INC. |
ANNE B CARLSON |
K003761 |
05/31/2001 |
NAT - NUCLEIC ACID TRANSPORT |
MEDICAL PACKAGING CORP. |
RICHARD CURTIS |
K002801 |
05/04/2001 |
MPS M ELECTRODE |
MEDICAL PHYSICS AND SERVICES, INC. |
HOWARD C THOMAS |
K010279 |
05/29/2001 |
MEDISYSTEMS LUER ACCESS INJECTION SITE |
MEDISYSTEMS CORP. |
KAREN KRSTULICH |
K010825 |
05/08/2001 |
MEDLINE STERISET STERILIZATION CONTAINER |
MEDLINE |
STACEY L BOLEN |
K010487 |
05/03/2001 |
BIPOLAR PENCIL, MODEL 3901-002, 3900-002 |
MEDTRONIC PS MEDICAL |
JANET MCAULEY |
K010361 |
05/07/2001 |
MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 |
MEDTRONIC PS MEDICAL |
CAROL BACCASH |
K010632 |
05/31/2001 |
BUTTERFLY PLATE FUNCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD W TREHARNE |
K011067 |
05/04/2001 |
MODIFICATION TO TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K011098 |
05/04/2001 |
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR |
MEDTRONIC VASCULAR |
STACEY P WESSMAN |
K010677 |
05/07/2001 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
MARTIN D SARGENT |
K010666 |
05/07/2001 |
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE |
MEDTRONIC XOMED, INC. |
MARTIN D SARGENT |
K011152 |
05/31/2001 |
VASOTRAC APM205A |
MEDWAVE, INC. |
DONNA R LUNAK |
K001120 |
05/08/2001 |
ENVOY PATIENT MONITOR |
MENNEN MEDICAL LTD. |
KEN RAICHMAN |
K010794 |
05/10/2001 |
BRIDGE III RECEIVER |
MERIDIAN MEDICAL TECHNOLOGIES LTD. |
RHONA LOVE |
K010380 |
05/09/2001 |
MP3HD BIG BOY, POWER WHEELCHAIR |
MERITS HEALTH PRODUCTS., INC. |
WINSTON ANDERSON |
K002058 |
05/29/2001 |
VECTORSURGE 5, MODEL VS-500 |
METRON MEDICAL AUSTRALIA PTY LTD |
ROB HOPKINS |
K010162 |
05/18/2001 |
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 |
MICRO THERAPEUTICS, INC. |
EBEN GORDON |
K010496 |
05/29/2001 |
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY |
MICROGENICS CORP. |
SHERRIE RINNE |
K010305 |
05/02/2001 |
WEISS RETINAL CANNULA |
MICRON SURGICAL, INC. |
APRIL DEAN |
K011430 |
05/31/2001 |
ACTIWARE-PLMS |
MINI-MITTER CO., INC. |
JACK E MCKENZIE |
K002639 |
05/11/2001 |
BIOKNOTLESS ANCHOR |
MITEK PRODUCTS |
MARY P LEGRAW |
K010633 |
05/09/2001 |
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM |
MITEK PRODUCTS |
MARY P LEGRAW |
K011111 |
05/30/2001 |
MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES) |
MODULAR X-RAY DEVICES |
S.B.B. DESEMBERG |
K003712 |
05/16/2001 |
MODIFICATION TO MALE TO MALE LUER ADAPTER |
MOLDED PRODUCTS INC. |
ELISE JOHNSTON |
K003505 |
05/25/2001 |
KFA-127 KNEE, FOOT AND ANKLE ARRAY |
MRI DEVICES CORP. |
TOM SCHUBERT |
K010881 |
05/16/2001 |
UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
N.S. UNI-GLOVES SDN. BHD. |
ROBERT D VANDER |
K010879 |
05/10/2001 |
UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
N.S. UNI-GLOVES SDN. BHD. |
ROBERT D VANDER LEEK |
K010813 |
05/07/2001 |
SIMPLICT |
NEORAD AS |
CHARLES H KYPER |
K011204 |
05/08/2001 |
NEUROFAX, MODELS EEG-1100A, EEG-9100A |
NIHON KOHDEN AMERICA, INC. |
BONNIE BISHOP |
K011286 |
05/16/2001 |
POWDER-FREE NITRILE EXAM GLOVE, BLUE |
NINGBO YUJIANG PLASTIC & RUBBER CO. LTD. |
JANNA P TUCKER |
K011120 |
05/08/2001 |
GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES |
NIPRO DIABETES SYSTEMS, INC. |
KAELYN B HADLEY |
K003320 |
05/02/2001 |
PTA-OS SIZING BALLOON, MODEL 360 |
NUMED, INC. |
NICHELLE LAFLESH |
K001971 |
05/24/2001 |
HEMODIALYSIS TUBING SETS |
OFI BIOMEDICA S.P.A. |
MARY MCNAMARA-CULLINANE |
K010620 |
05/17/2001 |
ENDOSCOPIC STAPLE REMOVAL INSTRUMENT |
ONUX MEDICAL, INC. |
JOHN RICE |
K004049 |
05/23/2001 |
POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS) |
OPTECH, INC. |
MARTIN DALSING |
K011027 |
05/30/2001 |
FORTAFLEX SURGICAL SLING |
ORGANOGENESIS, INC. |
PATRICK R BILBO |
K011050 |
05/04/2001 |
MICROSTREAM ORAL NASAL CANNULA FILTERLINE |
ORIDION MEDICAL 1987 LTD. |
SANFORD BROWN |
K010322 |
05/02/2001 |
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) |
ORTHODYNE, INC. |
CARL KNOBLOCH |
K010369 |
05/08/2001 |
CLARIS PLATE SYSTEM |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
K003733 |
05/29/2001 |
SCS CLOSED SCREW |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
K003918 |
05/22/2001 |
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES |
Oscor Inc. |
MILA DOSKOCIL |
K010787 |
05/22/2001 |
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS |
Oscor Inc. |
MILA DOSKOCIL |
K010783 |
05/30/2001 |
2.0/2.4 CANNULATED SCREW SYSTEM |
OSTEOMED CORP. |
DAWN T HOLDEMAN |
K003609 |
05/16/2001 |
N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 |
OSTEOMETER BIOTECH A/S |
PER QVIST |
K010580 |
05/22/2001 |
PALOMAR SLP 1000 |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Marcy Moore |
K003318 |
05/22/2001 |
PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X |
PARADIGM MEDICAL INDUSTRIES, INC. |
TRACY S BEST |
K010475 |
05/07/2001 |
D/C CORE MATERIAL |
PARKELL, INC. |
NELSON J GENDUSA |
K011271 |
05/08/2001 |
POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED |
PERUSAHAAN GETAH ASAS SDN BHD |
TAN KONG CHAN |
K010691 |
05/08/2001 |
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
DUANE PRASCHAN |
K003504 |
05/11/2001 |
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS |
PLUS ORTHOPEDICS |
HARMTMUT LOCH |
K011258 |
05/24/2001 |
TC-PLUS POROUS FEMORAL COMPONENTS |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
K011288 |
05/24/2001 |
TC-PLUS POROUS TIBIAL COMPONENTS |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
K010483 |
05/03/2001 |
POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0 |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
K002043 |
05/21/2001 |
PELVEX HOMETRAINER |
PURDUE TECHNOLOGY PARK |
CHRISTOPH WEISMAYER |
K002742 |
05/01/2001 |
SPHYGMOCOR MX MODEL SCOR-MX |
PWV MEDICAL PTY, LT. |
KIRSTEN H PAULSON |
K011105 |
05/30/2001 |
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE |
QRC CONSULTING |
DEBBIE IAMPIETRO |
K011097 |
05/08/2001 |
QUICKVUE DIPSTICK STREP A |
QUIDEL CORP. |
Robin Weiner |
K010470 |
05/11/2001 |
R & D 4K RETIC |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
K011287 |
05/25/2001 |
RADIUS COUGAR WIRE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
DEBBIE IAMPIETRO |
K010855 |
05/15/2001 |
RANDOX IGE |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K010700 |
05/08/2001 |
RANDOX MYOGLOBIN |
RANDOX LABORATORIES, LTD. |
P. ARMSTROMG |
K011107 |
05/14/2001 |
MODIFICATION TO SOLO |
RANGER ALL SEASON CORP. |
RON STEWART |
K003500 |
05/30/2001 |
REBSTOCK YASARGIL ANEURYSM CLIP |
REBSTOCK - INSTRUMENTE GMBH |
DIETER REBSTOCK |
K010436 |
05/14/2001 |
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
CHRIS HANNAN |
K010809 |
05/23/2001 |
BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000 |
RF INDUSTRIES, LTD. |
DICK ROBERTS |
K011065 |
05/09/2001 |
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K011480 |
05/24/2001 |
VIVA |
RICHTER RUBBER TECHNOLOGY SDN. BHD. |
FRANK C SADLO |
K010978 |
05/18/2001 |
TINA-QUANT ALPHA-1 ANTITRYPSIN |
ROCHDIAG |
KAY A TAYLOR |
K003400 |
05/10/2001 |
CRP HS TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K011143 |
05/29/2001 |
TINA-QUANT D-DIMER TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K003064 |
05/01/2001 |
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K010816 |
05/10/2001 |
DENTO-PREP PARTICLE MICROBLASTER |
RONVIG A/S |
ANNETTE RAVN NIELSEN |
K010420 |
05/09/2001 |
RUSCH MMG/O'NEIL CATHETER |
RUSCH, INC. |
WILLIAM SLEVIN |
K011064 |
05/17/2001 |
CLASSIC CEM |
S & C POLYMER GMBH |
JURGEN ENGELBRECHT |
K011369 |
05/29/2001 |
ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) |
SAFETY SYRINGES, INC. |
THOMAS L HALL |
K010519 |
05/14/2001 |
MAGNUM FLOW IRRIGATION SYSTEM |
SCION VALLEY, INC. |
C. KENNETH FRENCH |
K010659 |
05/16/2001 |
SEA-LONG MEDICAL TREATMENT HOOD |
SEA-LONG MEDICAL SYSTEMS, INC. |
GERALD COX |
K010710 |
05/18/2001 |
SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES |
SEEDLING ENTERPRISES. LLC. |
DEBBIE IAMPIETRO |
K011474 |
05/31/2001 |
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
K010773 |
05/30/2001 |
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
K010644 |
05/18/2001 |
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 |
SKIL-CARE CORP. |
ARNOLD SILVERMAN |
K010818 |
05/24/2001 |
INFANT LIMB HOLDER, MODELS 306080 & 306081 |
SKIL-CARE CORP. |
ARNOLD SILVERMAN |
K010557 |
05/25/2001 |
JAX GRANULES BONE VOID FILLER |
SMITH & NEPHEW, INC. |
TRUDE C MCLEAN |
K011089 |
05/23/2001 |
SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C |
SPECIALTY ULTRAVISION, INC. |
DEBBIE MCINTIRE |
K010563 |
05/25/2001 |
END-TO-END AND SIDE-BY-SIDE CONNECTORS |
SPINAL CONCEPTS, INC. |
DAVID M HOOPER |
K010639 |
05/30/2001 |
CONVERGENCE CERVICAL SPINAL SYSTEM |
SPINAL INNOVATIONS, LLC. |
KENNETH RUSSELL |
K003446 |
05/21/2001 |
SYMMETRY AORTIC CLIP SYSTEM |
ST. JUDE MEDICAL CARDIOVASCULAR GROUP, INC. |
ROBERT L SHERIDAN |
K010728 |
05/21/2001 |
HARMONE-SCHWARZER EEG SYSTEM |
STELLATE SYSTEMS |
GEORGE PAPAGIANNIS |
K010865 |
05/31/2001 |
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY |
STERIS Corporation |
RAYMOND URSICK |
K011088 |
05/02/2001 |
SIII ALARM AMPLIFIER |
STOCKERT INSTRUMENTE GMBH |
ROSINA ROBINSON |
K010291 |
05/10/2001 |
ITI DENTAL IMPLANT SYSTEM |
STRAUMANN USA |
LINDA JALBERT |
K011381 |
05/25/2001 |
HUMMER IV MICRODEBRIDER SYSTEM |
STRYKER INSTRUMENTS |
ROBIN L ROWE |
K003486 |
05/17/2001 |
STEREOTACTIC FRAME BASED SYSTEM |
STRYKER INSTRUMENTS |
ROBIN L ROWE |
K011028 |
05/21/2001 |
SCREW-VENT DENTAL IMPLANT SYSTEM |
SULZER DENTAL, INC. |
DIANA SMITH |
K011038 |
05/15/2001 |
TAPER-LOCK DENTAL IMPLANT SYSTEM |
SULZER DENTAL, INC. |
DIANA SMITH |
K010177 |
05/17/2001 |
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
K010449 |
05/04/2001 |
IVD (IN VIVO DOSIMETER), MODEL 1131 |
SUN NUCLEAR CORP. |
NOEL M DOWNEY |
K003123 |
05/04/2001 |
RENAX A.V. FISTULA NEEDLE SETS |
SUNDER BIOMEDICAL TECH. CO., LTD. |
TONY HUNG |
K003626 |
05/04/2001 |
DEVILBISS HUMIDIFIER |
SUNRISE MEDICAL HHG, INC. |
ALLAN R JONES |
K011268 |
05/15/2001 |
BREEZY WHEELCHAIR, MODEL 300 |
SUNRISE MEDICAL, INC. |
JOHN GERHOLD |
K010917 |
05/15/2001 |
POWER TILT AND RECLINE SYSTEM |
SUNRISE MEDICAL, INC. |
JOHN GERHOLD |
K001442 |
05/31/2001 |
ESU HANDSWITCHING PENCIL |
SURGEX, INC. |
DANIEL J MANELLI |
K010542 |
05/08/2001 |
SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION |
SURGICAL NAVIGATION SPECIALISTS, INC. |
CAROL NAKAGAWA |
K003836 |
05/29/2001 |
SYNTHES SYNEX SPACER SYSTEM |
SYNTHES |
JONATHAN GILBERT |
K010344 |
05/03/2001 |
ADJUSTABLE LARGE FIXATOR SYSTEM |
SYNTHES (USA) |
BONNIE J SMITH |
K010321 |
05/02/2001 |
MODULAR FOOT SYSTEM - 2.7 MM MODULE |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K010499 |
05/03/2001 |
SYNTHES (USA) MIDFACE DISTRACTOR |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K010518 |
05/23/2001 |
SYNTHES ANTEROLATERAL CALCANEAL PLATE |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K003788 |
05/30/2001 |
SYNTHES RESORABLE MESHES AND SHEETS |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K010690 |
05/18/2001 |
SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K011347 |
05/17/2001 |
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 |
SYVA CO. |
SUSAN COLLINS |
K011306 |
05/16/2001 |
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 |
SYVA CO., DADE BEHRING, INC. |
CYNTHIA ARREDONO |
K011300 |
05/17/2001 |
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 |
SYVA CO., DADE BEHRING, INC. |
VIRGINIA SINGER |
K011289 |
05/15/2001 |
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 |
SYVA CO., DADE BEHRING, INC. |
SUSAN COLLINS |
K011166 |
05/10/2001 |
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 |
SYVA CO., DADE BEHRING, INC. |
VIRGINIA SINGER |
K011162 |
05/02/2001 |
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY |
SYVA CO., DADE BEHRING, INC. |
SUSAN COLLINS |
K011164 |
05/10/2001 |
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 |
SYVA CO., DADE BEHRING, INC. |
CYNTHIA ARREDONDO |
K011161 |
05/15/2001 |
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 |
SYVA CO., DADE BEHRING, INC. |
SUSAN COLLINS |
K011163 |
05/10/2001 |
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 |
SYVA CO., DADE BEHRING, INC. |
SUSAN COLLINS |
K010438 |
05/01/2001 |
MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS) |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
K010439 |
05/01/2001 |
MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
K011142 |
05/08/2001 |
AQUARIUS WORKSTATION |
TERARECON, INC. |
DAVID W SCHLERF |
K002193 |
05/04/2001 |
TETRAD TC-C3-ACP |
TETRAD CORP. |
DENNIS R DIETZ |
K011149 |
05/15/2001 |
DISPOSABLE BENDING CANNULA PR-233Q |
THE OLYMPUS OPTICAL CO. |
LAURA STOMS-TYLER |
K011151 |
05/15/2001 |
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
K010466 |
05/16/2001 |
TETHER ACFS |
THEKEN SURGICAL,LLC |
ROBERT THEKEN |
K010472 |
05/08/2001 |
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50 |
THOMSON & NIELSEN ELECTRONICS, LTD. |
ANDREW HARTSHORN |
K002718 |
05/01/2001 |
ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB |
TILLOTSON HEALTHCARE CORP. |
F.W. PERRELLA |
K010661 |
05/03/2001 |
MODIFICATION TO TISSUELINK BIPOLAR FORCEPS |
TISSUELINK MEDICAL, INC. |
ROBERTA THOMPSON |
K004018 |
05/11/2001 |
SKINGARD POLYCOAT GLOVE |
TOP QUALITY MFG., INC. |
ART WARD |
K011418 |
05/24/2001 |
ULTRAGUIDE MR-GUIDE 3000 |
ULTRAGUIDE LTD. |
GEORGE MYERS |
K003890 |
05/22/2001 |
VHF ULTRASONIC ARC-SCAN SYSTEM |
ULTRALINK, LLC. |
GEORGE D WISEMAN |
K010946 |
05/30/2001 |
MARK 9000 PHASED ARRAY SHOULDER COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
K010730 |
05/16/2001 |
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
K010716 |
05/30/2001 |
VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB |
VAL MED CORP. |
HOWARD M HOLSTEIN |
K010975 |
05/02/2001 |
ECLIPSE 6.5 |
VARIAN MEDICAL SYSTEMS, INC. |
LINDA NASH |
K002831 |
05/23/2001 |
VEGA ULTRASONIC NEBULIZER |
VEGA TECHNOLOGIES, INC. |
JOSEPH LU |
K010638 |
05/03/2001 |
NEUROPLUS, MODEL A10040, A10041, A10042, A10043 |
VERMONT MEDICAL, INC. |
MARC FILLION |
K011374 |
05/29/2001 |
JEWEL MPS |
VESTIL MANUFACTURING CORP. |
RICK MICHAEL |
K010936 |
05/21/2001 |
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL |
W.L. GORE & ASSOCIATES,INC |
R. LARRY PRATT |
K003402 |
05/01/2001 |
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION |
WELCON, INC. |
PAMELA PAPINEAU |
K010747 |
05/16/2001 |
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830 |
WESTERN ENT. |
BYRON CRAMPTON |
K003618 |
05/23/2001 |
WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 |
WHITESIDE BIOMECHANICS, INC. |
DEBRA MEYER |
K011178 |
05/04/2001 |
WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR |
WILSON-COOK MEDICAL, INC. |
MARGARET J POSNER |
K011290 |
05/30/2001 |
PROGNOST ES, MODEL 0302 0000 |
XMAR CORP. |
NEIL BARRETT |
K011376 |
05/25/2001 |
EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200 |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
JANNA P TUCKER |