FDA 510(k) Decisions During May, 2001  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K011167 05/17/2001 XSE 3M COMPANY KAREN O'MALLEY
K010183 05/02/2001 GLOBAL BY BLASTOCYST MEDIA INTL., INC. MICHAEL D CECCHI
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
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K003712 05/16/2001 MODIFICATION TO MALE TO MALE LUER ADAPTER MOLDED PRODUCTS INC. ELISE JOHNSTON
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K010291 05/10/2001 ITI DENTAL IMPLANT SYSTEM STRAUMANN USA LINDA JALBERT
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K003486 05/17/2001 STEREOTACTIC FRAME BASED SYSTEM STRYKER INSTRUMENTS ROBIN L ROWE
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K002193 05/04/2001 TETRAD TC-C3-ACP TETRAD CORP. DENNIS R DIETZ
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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
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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
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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


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