FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K011524 |
05/17/2001 |
IMMEDIATE STABILIZING DEVICE (ISD) |
"O" CO., INC. |
DAVID D DALISE |
K011512 |
05/16/2001 |
MMODIFICATION TO LAMINARIA |
A & A MEDICAL, INC. |
JIHAD (JAY) MANSOUR |
K011442 |
05/10/2001 |
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 |
ABBOTT LABORATORIES |
FRANK POKROP |
K011461 |
05/14/2001 |
ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR |
ACCESS CARDIOSYSTEMS, INC. |
DAVID BARASH |
K011337 |
05/02/2001 |
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) |
ACCUMETRICS, INC. |
RHONDA MOE |
K011673 |
05/30/2001 |
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K011672 |
05/30/2001 |
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K011353 |
05/03/2001 |
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K011618 |
05/25/2001 |
CALGITROL AG SILVER ALGINATE WOUND DRESSING |
ADRI |
GEORGE H SCHERR |
K011422 |
05/09/2001 |
SURGICAL DRAPES |
ADVANCE MEDICAL DESIGNS, INC. |
BILL GILL |
K011372 |
05/04/2001 |
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE |
AESCULAP, INC. |
STEVE REITZLER |
K011375 |
05/04/2001 |
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE |
AESCULAP, INC. |
STEVE REITZLER |
K011556 |
05/21/2001 |
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM |
AESCULAP, INC. |
LISA M MILLINGTON |
K011578 |
05/22/2001 |
M2376A DEVICELINK SYSTEM, MODEL M2376A |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
K011457 |
05/11/2001 |
ALOKA SSD-5500 WITH KI AND A-SMA |
ALOKA CO., LTD. |
KELVIN BURROUGHS |
K011415 |
05/08/2001 |
ALPCO MILENIA ANTI-TG EIA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD E CONLEY |
K011581 |
05/23/2001 |
AMERITEK BRACHYTHERAPY TEMPLATE |
AMERTEK MEDICAL, INC. |
GREG WIITA |
K011592 |
05/24/2001 |
OXYGEN TREATMENT HOOD |
AMRON INTERNATIONAL DIVING SUPPLY, INC. |
NORMA F OCKWIG |
K011593 |
05/24/2001 |
MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE |
ANSELL HEALTHCARE PRODUCTS, INC. |
JAMES R CHATTERTON |
K011552 |
05/18/2001 |
UROLOGICAL CATHETER |
APOGEE MEDICAL, INC. |
BRENT D ROBLING |
K011601 |
05/24/2001 |
ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX |
ARDO MEDICAL AG |
EVA KRAHENBUHL |
K011495 |
05/15/2001 |
ARTHREX BIO-POST AND WASHER |
ARTHREX, INC. |
ANN WATERHOUSE |
K011634 |
05/29/2001 |
ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H0970-02; FOOTSWITCH, MODEL H2000-04; POWERCORD, MODEL H2000 |
ARTHROCARE CORP. |
BETTY M JOHNSON |
K011534 |
05/18/2001 |
EEG MIS MONITOR MODEL # A-2000; BIS ENGINE |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE M VOZELLA |
K011674 |
05/30/2001 |
DC - CRISTAL |
AUSTENAL, INC. |
RONALD DUDEK |
K011417 |
05/09/2001 |
ULTRASOUND SCANNER, TYPE 2102 |
B-K MEDICAL A/S |
VILLY BRAENDER |
K011446 |
05/11/2001 |
BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES |
BARRIERMED, INC. |
CARLO PONCIPE |
K011504 |
05/16/2001 |
BAUMER LOCKING NAIL |
BAUMER S.A. |
BRENO CORREA FARAGO JR. |
K011342 |
05/02/2001 |
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 |
BECKMAN COULTER, INC. |
STAN SUGRUE |
K011465 |
05/14/2001 |
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO |
BECKMAN COULTER, INC. |
MARY B TANG |
K011518 |
05/17/2001 |
VITALSAT SERIES |
BETA BIOMED SERVICES, INC. |
E J SMITH |
K011494 |
05/15/2001 |
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL |
BIO-RAD |
DONNA CHAPMAN |
K011579 |
05/22/2001 |
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 |
BIO-RAD |
Yvette Lloyd |
K011675 |
05/30/2001 |
THE AUTOTAC SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
DONALD E DALTON |
K011355 |
05/03/2001 |
BIOLIGHT PCD |
BIOLIGHT INTERNATIONAL AB |
CONSTANCE G BUNDY |
K011509 |
05/16/2001 |
BARRETT UNICONDYLAR TIBIAL BEARING |
BIOMET, INC. |
TRACY J BICKEL |
K011399 |
05/07/2001 |
BIOMET CRANIOFACIAL ACRYLIC CEMENT |
BIOMET, INC. |
MICHELLE L MCKINLEY |
K011455 |
05/11/2001 |
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER |
BIOMET, INC. |
TRACY J BICKEL |
K011531 |
05/17/2001 |
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER |
BIOMET, INC. |
DALENE T BINKLEY |
K011554 |
05/18/2001 |
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
K011522 |
05/17/2001 |
RESORBABLE BONE PINS |
BIOMET, INC. |
MARY L VERSTYNEN |
K011451 |
05/11/2001 |
REUNITE FUSION SCREW |
BIOMET, INC. |
SARA BAILEY SHULTZ |
K011328 |
05/01/2001 |
CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH |
BIONET COMPANY LTD |
MIN SOO HAN |
K011569 |
05/21/2001 |
BIOSORBFX O/M 2.0/2/4 SYSTEM |
BIONX IMPLANTS, INC. |
TUIJA ANNALA |
K011380 |
05/07/2001 |
MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM |
BIOPLATE, INC. |
CAROL E JONES |
K011459 |
05/11/2001 |
WUJIN #3 FEMORAL BONE PLATE |
BIOPRO, INC. |
PATRICK PRINGLE |
K011460 |
05/11/2001 |
WUJIN #3 TIBIAL BONE PLATE |
BIOPRO, INC. |
PATRICK PRINGLE |
K011525 |
05/17/2001 |
SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) |
BIOSAFE LABORATORIES, INC. |
LAURIE A WATERS |
K011664 |
05/30/2001 |
IMAGER II ANGIOGRAPHIC CATHETER |
BOSTON SCIENTIFIC/MEDI-TECH |
JODI L GREENIZEN |
K011589 |
05/23/2001 |
CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M |
BYPASS LTD. |
JONATHAN S KAHAN |
K011324 |
05/01/2001 |
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
K011389 |
05/07/2001 |
HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) |
CANTERBURY HEALTH LABORATORIES |
MAURICE OWEN |
K011439 |
05/10/2001 |
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR |
CARDIODYNAMICS INTERNATIONAL CORP. |
BRIAN PARK |
K011689 |
05/31/2001 |
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT |
CATCH, INC. |
MARK E LEGAZ |
K011361 |
05/03/2001 |
DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE |
CATHEFFECTS, LLC. |
SHAWN FOJTIK |
K011419 |
05/09/2001 |
CAVEX COLORCHANGE |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
K011452 |
05/11/2001 |
CAVEX STABISIL |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
K011550 |
05/18/2001 |
HCG STAT PAK ULTRA-FAST |
Chembio Diagnostic Systems, Inc. |
FRAN WHITE |
K011551 |
05/18/2001 |
SURE CHECK PREGNANCY TEST |
Chembio Diagnostic Systems, Inc. |
FRAN WHITE |
K011336 |
05/02/2001 |
PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK |
CHURCHILL MEDICAL SYSTEMS, INC. |
KEITH PAULCH |
K011454 |
05/11/2001 |
SPINE SCOPE, MODEL 2180 |
CLARUS MEDICAL, LLC. |
TOM BARTHEL |
K011695 |
05/31/2001 |
COLLAGEN DENTAL MEMBRANE |
COLLAGEN MATRIX, INC. |
SHU-TUNG LI |
K011344 |
05/02/2001 |
INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 |
COLLINS MEDICAL, INC. |
JONATHAN S KAHAN |
K011481 |
05/14/2001 |
10% PVP; 10% PVP IN EBSS SOLUTION |
CONCEPTION TECHNOLOGIES |
GRACE HOLLAND |
K011573 |
05/21/2001 |
HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM |
CONCEPTION TECHNOLOGIES |
GRACE HOLLAND |
K011462 |
05/14/2001 |
OIL FOR TISSUE CULTURE |
CONCEPTION TECHNOLOGIES |
GRACE HOLLAND |
K011677 |
05/30/2001 |
MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER |
CONTINUUM ELECTRO-OPTICS, INC. |
RONALD KOHLHARDT |
K011502 |
05/16/2001 |
CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM |
CRYSTAL-SEAL DENTAL IMPLANTS |
CLINT FOLSOM |
K011665 |
05/30/2001 |
BCT SYSTEM |
DADE BEHRING, INC. |
REBECCA S AYASH |
K011611 |
05/25/2001 |
CARDIOCAM MODEL 9CSY0799 |
DANISH DIAGNOSTIC DEVELOPMENT A/S |
NIELS S ORENSEN |
K011436 |
05/10/2001 |
MOBILE-PATIENT VIEWER |
DATA CRITICAL CORPORATION |
FLORIN TRUUVERT |
K011540 |
05/18/2001 |
VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07 |
DATASCOPE CORP. |
SUSAN E MANDY |
K011670 |
05/30/2001 |
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE |
DATEX-OHMEDA |
JOEL C KENT |
K011333 |
05/02/2001 |
CERCON CERAM |
DEGUSSA - NEY DENTAL, INC. |
THOMAS C CAMERON |
K011400 |
05/07/2001 |
MRSA-SCREEN |
DENKA SEIKEN'S |
KEVIN MANGAN |
K011425 |
05/09/2001 |
CARMEN |
DENTAURUM, INC. |
THOMAS J ANDERSON |
K011428 |
05/09/2001 |
TRICERAM |
DENTAURUM, INC. |
THOMAS J ANDERSON |
K011560 |
05/21/2001 |
TRUBYTE DENTURE BASE RESIN SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K011533 |
05/18/2001 |
DEPUY FEMORAL HEADS |
DEPUY ORTHOPAEDICS, INC. |
LYNNETTE WHITAKER |
K011367 |
05/04/2001 |
EXCEL FRACTURE CEMENTED HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
SALLY FOUST |
K011489 |
05/15/2001 |
SUMMIT DUOFIX HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
K011505 |
05/16/2001 |
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K011586 |
05/23/2001 |
IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE |
DIAMETRICS MEDICAL, INC. |
NANCY RING |
K011572 |
05/21/2001 |
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) |
DIGIRAD CORP. |
COREY STEWART |
K011390 |
05/07/2001 |
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
ELAD MAGAL |
K011354 |
05/03/2001 |
HIGH TIBIAL OSTEOTOMY PLATING SYSTEM |
DJ ORTHOPEDICS, LLC |
JAMAL D RUSHDY |
K011322 |
05/01/2001 |
DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE |
DORNIER MEDTECH AMERICA, INC. |
BRIAN WALSH |
K011404 |
05/08/2001 |
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS |
DRAEGER MEDICAL, INC. |
MICHAIL A KELHART |
K011383 |
05/07/2001 |
MICRODOSE CATH, MODELS 90121-201, -202, -203 |
DURECT CORP. |
JEFF P MILLER |
K011537 |
05/18/2001 |
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS |
DYNAMIC TECHNOLOGY CORP. |
YAW C YANG |
K011329 |
05/01/2001 |
ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER |
E. BENSON HOOD LAB, INC. |
LEWIS MARTEN |
K011386 |
05/07/2001 |
EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE |
EBI, L.P. |
JON CAPAROTTA |
K011679 |
05/30/2001 |
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY |
EMBRYOTECH LABORATORIES, INC. |
ANN D MCGONIGLE |
K011516 |
05/17/2001 |
INFANT FLOW SYSTEM, MODEL M672P |
EME (ELECTRO MEDICAL EQUIPMENT) LTD. |
STUART CORNER |
K011438 |
05/10/2001 |
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. |
ENTIFIC MEDICAL SYSTEMS, INC. |
CONSTANCE BUNDY |
K011587 |
05/23/2001 |
SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP |
ENTRACON CORP. |
PAUL ZANNECHIA |
K011394 |
05/07/2001 |
LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM |
ESPE DENTAL AG |
ANDREAS PETERMANN |
K011538 |
05/18/2001 |
ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM |
ETHICON ENDO-SURGERY, INC. |
ELIZABETH MILLER |
K011501 |
05/16/2001 |
ENDOPOUCH RETRIEVER |
ETHICON ENDO-SURGERY, INC. |
DOUG KENTZ |
K011387 |
05/07/2001 |
NEUROTHERM, MODEL JK4 |
EUROLINK LLC. |
WILLIAM RITTMAN |
K011405 |
05/08/2001 |
EXEL INJECTION PLUG WITH CAP |
EXELINT INTL. CO. |
ARMAND HAMID |
K011530 |
05/17/2001 |
VERTRAN STANDING WHEELCHAIR |
FENA DESIGN, INC. |
ELAINE DUNCAN |
K011617 |
05/25/2001 |
LIFEJET PRINTER 400 |
FERRANIA S.P.A. STABILIMENTO DI FERRANIA |
RICCARDO GENTA |
K011517 |
05/17/2001 |
LUTE; CORE |
FIRST SCIENTIFIC LIMITED |
ADE AKINMADE |
K011521 |
05/17/2001 |
ORTHO VLC; ORTHO VLC CAPSULE |
FIRST SCIENTIFIC LIMITED |
ADE AKINMADE |
K011520 |
05/17/2001 |
RESTORE-X |
FIRST SCIENTIFIC LIMITED |
ADE AKINMADE |
K011485 |
05/15/2001 |
PINNACLE MAGNETIC RESONANCE IMAGING SCANNER |
FONAR CORP. |
LUCIANO BONANNI |
K011368 |
05/04/2001 |
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS |
GAMBRO RENAL PRODUCTS |
FEI LAW |
K011626 |
05/29/2001 |
CONCORD 72 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
K011628 |
05/29/2001 |
CONCORD 82 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
K011661 |
05/29/2001 |
CONCORD 88 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
K011659 |
05/29/2001 |
GPW-SF |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
K011624 |
05/25/2001 |
EXPEDIO 500D R&F X-RAY SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
K011604 |
05/24/2001 |
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
K011433 |
05/10/2001 |
BALLERT CRANIAL MOLDING HELMET |
GEMA, INC. |
GENE BERNARDONI |
K011506 |
05/16/2001 |
OMNILINK .035 BILIARY STENT SYSTEM |
GUIDANT CORP. |
CURTIS TRUESDALE |
K011565 |
05/21/2001 |
INFANT OXYGEN TREATMENT HOOD |
GULF COAST HYPERBARICS, INC. |
JAMES W MCCARTHY |
K011669 |
05/30/2001 |
BW ACUPUNCTURE NEEDLES |
H F INTL. CO. |
JOHN N POLITIS |
K011385 |
05/07/2001 |
HARDKYDISK NEOMYCIN, 30 MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR, RAC |
K011384 |
05/07/2001 |
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR, RAC |
K011666 |
05/30/2001 |
CHILLIT |
HEATSHIELD, INC. |
WILLIAM A PLOUMIS |
K011413 |
05/08/2001 |
POWDER-FREE VINYL EXAM GLOVE, YELLOW |
HEYUAN HONGLI INDUSTRIES, INC. |
JANNA TUCKER |
K011412 |
05/08/2001 |
POWDER-FREE VINYL EXAM GLOVES |
HEYUAN HONGLI INDUSTRIES, INC. |
JANNA P TUCKER |
K011414 |
05/08/2001 |
POWDERED VINAL EXAM GLOVES |
HEYUAN HONGLI INDUSTRIES, INC. |
JANNA TUCKER |
K011320 |
05/01/2001 |
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
ROBERT H MCCARTHY |
K011435 |
05/10/2001 |
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM |
HMT, INC. |
SEUNG K MO |
K011519 |
05/17/2001 |
AMEDA HYGIENIKIT |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
K011667 |
05/30/2001 |
HORIZONS INTERNATIONAL POLYPECTOMY SNARES |
HORIZONS INTL. CORP. |
RAFIC SALEH |
K011623 |
05/25/2001 |
EXETER HIP SYSTEM WITH V40 TAPER |
HOWMEDICA OSTEONICS CORP. |
NANCY J RIEDER |
K011622 |
05/25/2001 |
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K011643 |
05/29/2001 |
SCORPIO CR SUPERFLEX TIBIAL INSERT |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
K011529 |
05/17/2001 |
T2 HUMERAL NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K011612 |
05/25/2001 |
MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM |
HYDROCISION, INC. |
DEBBIE IAMPIETRO |
K011478 |
05/14/2001 |
I-STAT SYSTEM |
I-STAT CORP. |
PAUL VANDERWERF |
K011575 |
05/22/2001 |
22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 |
IMAGYN SURGICAL |
JULIE POWELL |
K011694 |
05/31/2001 |
VIEWSTATION |
IMPAC MEDICAL SYSTEMS, INC. |
THOMAS H FARIS |
K011423 |
05/09/2001 |
INPULSE DENTAL LASER |
INCISIVE, LLC. |
MICHAEL YESSIK |
K011566 |
05/21/2001 |
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K011570 |
05/21/2001 |
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K011424 |
05/09/2001 |
IL TEST PROS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K011437 |
05/10/2001 |
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS |
INTERPORE CROSS INTL. |
LYNN RODARTI |
K011692 |
05/31/2001 |
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT |
INTERSECT SYSTEMS, INC. |
MARK LEGAZ |
K011616 |
05/25/2001 |
INDUO BLOOD GLUCOSE METER |
INVERNESS MEDICAL INNOVATIONS, INC. |
CAROL A ADILETTO |
K011479 |
05/14/2001 |
ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM |
INVERNESS MEDICAL INNOVATIONS, INC. |
CAROL A ADILETTO |
K011598 |
05/24/2001 |
WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
K011365 |
05/04/2001 |
VITALSAT PULSE OXIMETER, MODEL IC32000 |
ISLAND CRITICAL CARE CORP. |
SEAN FLANIGAN |
K011491 |
05/15/2001 |
HELIOSEAL CLEAR CHROMA |
IVOCLAR NORTH AMERICA, INC. |
ANDERJEET GULATI |
K011492 |
05/15/2001 |
IN TEN-S |
IVOCLAR NORTH AMERICA, INC. |
ANDERJEET GULATI |
K011490 |
05/15/2001 |
MODIFICATION TO EXCITE |
IVOCLAR NORTH AMERICA, INC. |
DONNA MARIE HARTNETT |
K011596 |
05/24/2001 |
UREA NITROGEN (BUN) LIQUID REAGENT |
JAS DIAGNOSTIC, INC. |
David Johnston |
K011599 |
05/24/2001 |
ALKALINE PHOSPHATASE LIQUID REAGENT |
JAS Diagnostics, Inc. |
David Johnston |
K011441 |
05/10/2001 |
JAS CALCIUM (ARSENAZO) REAGENT |
JAS Diagnostics, Inc. |
David Johnston |
K011362 |
05/03/2001 |
GOLD CORE 73 LS |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
K011331 |
05/02/2001 |
JP CAST 40 |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
K011330 |
05/02/2001 |
JP CAST 50 |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
K011359 |
05/03/2001 |
MODIFICATION TO KSEA ENDOTIP SYSTEM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
K011514 |
05/17/2001 |
INSTRUMENTS FOR ONE TIME USE - DISPOSABLE |
KENCAP LTD. |
MARTY DELIN |
K011691 |
05/31/2001 |
KIMSTIM AURICULAR ELECTRODE |
KIM INSTITUTE FOR REHABILITATION MEDICINE, P.C. |
DONALD F GRABARZ |
K011590 |
05/23/2001 |
RESORB-X RESORBABLE PLATING SYSTEM |
KLS-MARTIN L.P. |
ARTHUR WARD |
K011340 |
05/02/2001 |
LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT |
LH MEDICAL PRODUCTS, INC. |
LONNIE HUTSON |
K011343 |
05/02/2001 |
LH 500 ENTERAL FEEDING GRAVITY BAG SET |
LH MEDICAL PRODUCTS, INC. |
LONNIE HUTSON |
K011341 |
05/02/2001 |
LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET |
LH MEDICAL PRODUCTS, INC. |
LONNIE HUTSON |
K011562 |
05/21/2001 |
LUMEND PERCUTANEOUS CATHETER |
LUMEND, INC. |
MICHAEL A DANIEL |
K011378 |
05/03/2001 |
JOE LUB HELMET CONDOM |
MARKETING SALES CONCEPTS, INC. (MSCI) |
ERIC J ARTHUR |
K011363 |
05/03/2001 |
JOE LUBE CONDOM |
MARKETING SALES CONCEPTS, INC. (MSCI) |
ERIC J ARTHUR |
K011621 |
05/25/2001 |
KOALA CLAMP, KOALA CLAMP AND CUTTER |
MATERNUS, INC. |
RONALD B HICKS |
K011373 |
05/04/2001 |
INSTRUMENT DAMPING PORT |
MEDCANICA, INC. |
AL WEISENBORN |
K011349 |
05/02/2001 |
INTERCOSTAL LOCKABLE-DIRECTABLE PORT |
MEDCANICA, INC. |
CHRISTIAN L MAZZOLA |
K011608 |
05/25/2001 |
MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL |
MEDICAL ADVANCES, INC. |
MICHAEL J LEIGH |
K011548 |
05/18/2001 |
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
DARWIN RICHARDSON |
K011576 |
05/22/2001 |
MEDCOMP ASH SPLIT |
MEDICAL COMPONENTS, INC. |
JEANNE M CUSH |
K011325 |
05/01/2001 |
MEDIFIX URETEROSCOPE |
MEDIFIX, INC. |
GEORGE ALBULESCU |
K011582 |
05/23/2001 |
QCU ANALYTICAL SOFTWARE PACKAGE |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.J. HOLLANDER |
K011515 |
05/17/2001 |
MEDLINE GROUNDING PAD |
MEDLINE INDUSTRIES, INC. |
STACEY L BOLEN |
K011545 |
05/18/2001 |
VERDICT -II TCA, VERDICT-II MTD |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
K011471 |
05/14/2001 |
BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
TOVE KJAER |
K011472 |
05/14/2001 |
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
TOVE KJAER |
K011443 |
05/11/2001 |
THREADED CEMENT RESTRICTOR (CR) TITANIUM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TREHARNE |
K011508 |
05/16/2001 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K011406 |
05/08/2001 |
SPINAL MESH SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K011395 |
05/07/2001 |
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B |
MEDTRONIC VASCULAR |
CHARLES DOWD |
K011584 |
05/23/2001 |
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF |
MEDTRONIC VASCULAR |
DAVID H MUELLER |
K011500 |
05/16/2001 |
MENTOR CONTOUR PROFILE TISSUE EXPANDER |
MENTOR CORP. |
DONNA CRAWFORD |
K011493 |
05/15/2001 |
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY |
MENTOR CORP. |
GEORGE HOEDEMAN |
K011687 |
05/31/2001 |
MP-3C POWER BASE CHAIR, MODEL MP3C |
MERITS HEALTH PRODUCTS., INC. |
WINSTON ANDERSON |
K011513 |
05/16/2001 |
MP3U, POWER WHEELCHAIR |
MERITS HEALTH PRODUCTS., INC. |
WINSTON ANDERSON |
K011585 |
05/23/2001 |
FAST THERMOMETER MODELS ST713C AND ST713F |
MESURE TECHNOLOGY |
PHIL ZULUETA |
K011657 |
05/29/2001 |
HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
K011392 |
05/07/2001 |
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER |
MICRA INSTRUMENTS |
JOHN A.K. BASKERVILLE |
K011535 |
05/18/2001 |
CADENCE PRECISION INJECTOR, MODEL 103-0304 |
MICRO THERAPEUTICS, INC. |
EBEN GORDON |
K011656 |
05/29/2001 |
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771 |
MICRO THERAPEUTICS, INC. |
EBEN GORDON |
K011526 |
05/17/2001 |
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 |
MICRO THERAPEUTICS, INC. |
EBEN GORDON |
K011318 |
05/01/2001 |
VENODYNE DVT ADVANTAGE PLUS |
MICROTEK MEDICAL, INC. |
TOM BONNER |
K011416 |
05/08/2001 |
MUSCLE IMAGING SYSTEM (MIS) |
MILLENNIUM MAGNETIC IMAGING, INC. |
DONALD H MARKS |
K011427 |
05/08/2001 |
MBI PD-103 SL; MBI PD-103 SH |
MILLS BIOPHARMACEUTICALS, INC. |
STANLEY MILLS |
K011430 |
05/09/2001 |
ACTIWARE-PLMS |
MINI-MITTER CO., INC. |
JACK E MCKENZIE |
K011360 |
05/03/2001 |
MTP LAPAROMAT DISPOSABLE TUBING SET |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
JAMES A LEE |
K011420 |
05/09/2001 |
MM-87 MOTOR-DRIVE MANIPULATOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
K011564 |
05/21/2001 |
NEOLEAD |
NEOTECH PRODUCTS, INC. |
ARNOLD M HEYMAN |
K011646 |
05/29/2001 |
NEUROEDGE INFUSION CATHETER |
NEURO VASX, INC. |
JACK SLOVICK |
K011606 |
05/24/2001 |
PURESPERM BUFFER |
NIDACON INTERNATIONAL AB |
DANIEL KAMM |
K011346 |
05/02/2001 |
READYSWIM |
NIDACON INTERNATIONAL AB |
DANIEL KAMM |
K011607 |
05/24/2001 |
SPERMCATCH |
NIDACON INTERNATIONAL AB |
DANIEL KAMM |
K011450 |
05/11/2001 |
SILICONE IMPRESSION MATERIAL |
NORTHEAST RESINS & SILICONES, LLC. |
SIVANANDA S JADA |
K011557 |
05/21/2001 |
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS |
NUMED, INC. |
NICHELLE R LAFLESH |
K011577 |
05/22/2001 |
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S |
OCU-EASE OPTICAL PRODUCTS, INC. |
CHARLES R VERMETTE |
K011549 |
05/18/2001 |
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM |
OHMEDA MEDICAL |
ALBERTO F PROFUMO |
K011484 |
05/14/2001 |
OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
K011652 |
05/29/2001 |
BODY FAT ANALYZER, MODEL HBF-306 |
OMRON HEALTHCARE, INC. |
OSAMU SHIRASAKI |
K011498 |
05/15/2001 |
EASY CONTROL MICRO INSERTER, MODEL ON385 |
OPHTEC USA, INC. |
RICK MCCARLEY |
K011536 |
05/18/2001 |
MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE |
ORIDION MEDICAL 1987 LTD. |
SANFORD BROWN |
K011668 |
05/17/2001 |
VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI |
ORIDION MEDICAL 1987 LTD. |
SANDY BROWN |
K011463 |
05/14/2001 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS |
ORTHO-CLINICAL DIAGNOSTICS |
Darlene J Phillips |
K011403 |
05/07/2001 |
SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE |
ORTHOGEN CORP. |
ELAINE DUNCAN |
K011350 |
05/02/2001 |
STARBAND CRANIAL ORTHOSIS |
ORTHOMERICA PRODUCTS, INC. |
WILLIAM H VON OEHSEN |
K011338 |
05/02/2001 |
OTO-CEM |
OTOTECH, INC. |
MICHAEL G FARROW |
K011411 |
05/08/2001 |
SELF-ADHESIVE ELECTRODES |
PAIN MANAGEMENT TECHNOLOGIES |
JOSHUA LEFKOVITZ |
K011609 |
05/25/2001 |
LIVESURE AMPHETAMINE SCREEN TEST |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
K011610 |
05/25/2001 |
LIVESURE METHAMPHETAMINE SCREEN TESTS |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
K011688 |
05/31/2001 |
PELVICFLEXER EXERCISE DEVICE |
PELVICFLEX, INC. |
SUSAN D GOLDSTEIN-FALK |
K011397 |
05/07/2001 |
PERSYST REVEAL |
PERSYST DEVELOPMENT CORP. |
SCOTT B WILSON |
K011382 |
05/07/2001 |
XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000 |
PHOTO MEDEX, INC. |
BOB ROSE |
K011619 |
05/25/2001 |
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT |
PLANMECA OY |
BOB PIENKOWSKI |
K011527 |
05/17/2001 |
PRAXSYS RELIA TSH TEST |
PRAXSYS BIOSYSTEMS, INC. |
RICHARD M THAYER |
K011532 |
05/18/2001 |
MITYVAC |
PRISM ENTERPRISES, INC. |
HOWARD M HOLSTEIN |
K011690 |
05/31/2001 |
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY |
PROXIMA THERAPEUTICS, INC. |
MARTINE D SCHNEIDER |
K011426 |
05/08/2001 |
PSYCHEMEDICS RIA CANNABINOID ASSAY |
PSYCHEMEDICS CORP. |
WILLIAM R THISTLE |
K011486 |
05/15/2001 |
Q-RAD RADIOGRAPHIC SYSTEM |
QUANTUM MEDICAL IMAGING, LLC. |
MARK CAMIRAND |
K011401 |
05/07/2001 |
RAMBLER |
RAMBLER MOBILITY, INC. |
JOEL HUSTED |
K011648 |
05/29/2001 |
RANDOX CARBAMAZEPINE |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K011568 |
05/21/2001 |
RANDOX LIPOPROTEIN |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
K011393 |
05/07/2001 |
RANDOX PHENYTOIN |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
K011649 |
05/29/2001 |
RANDOX VALPROIC ACID |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K011597 |
05/24/2001 |
SMARTMONITOR 2, MODEL 4000 |
RESPIRONICS GEORGIA, INC. |
BETSY CORTELLONI |
K011345 |
05/02/2001 |
CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM |
REYNOLDS MEDICAL LTD. |
GEORGE MYERS |
K011496 |
05/15/2001 |
CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K011480 |
05/14/2001 |
VIVA |
RICHTER RUBBER TECHNOLOGY SDN. BHD. |
FRANK C SADLO |
K011453 |
05/11/2001 |
TOOTH SHADE RESIN MATERIAL |
RITE-DENT MANUFACTURING CORP. |
CESAR E VELIZ |
K011658 |
05/29/2001 |
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS |
ROCHDIAG |
HELEN T TORNEY |
K011684 |
05/30/2001 |
INFLUENZA A/B RAPID TEST, CAT NO 2158 663 |
ROCHE DIAGNOSTICS CORP. |
LUANN OCHS |
K011467 |
05/14/2001 |
ROSS EMBRACE PUMP SET |
ROSS PRODUCTS |
DANIEL HAMILTON |
K011523 |
05/17/2001 |
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138 |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
K011539 |
05/18/2001 |
ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
K011352 |
05/03/2001 |
ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
K011431 |
05/09/2001 |
RESIN CEM |
S & C POLYMER GMBH |
CHRISTIAN BOTTCHER |
K011369 |
05/04/2001 |
ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) |
SAFETY SYRINGES, INC. |
THOMAS L HALL |
K011323 |
05/01/2001 |
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 |
SALIMETRICS LLC. |
EVE SCHWARTZ |
K011456 |
05/11/2001 |
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES |
SAUFLON PHARMACEUTICALS, LTD. |
JOHN M SZABOCSIK |
K011348 |
05/02/2001 |
PHASE II GBM IGG ANTIBODY EIA TEST |
SCIMEDX CORP. |
Gary Lehnus |
K011470 |
05/14/2001 |
SDI SB OFFICE, MODEL 29- |
SDI DIAGNOSTICS, INC. |
MICHAEL J BOYLE |
K011544 |
05/18/2001 |
HADGEL, 4 GRAM/SYRINGE |
SEIKAGAKU CORP. |
JOHN J SHEA |
K011749 |
05/31/2001 |
LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS |
SEMPERMED USA, INC. |
KATIE LEVINSON |
K011402 |
05/07/2001 |
BIOPSY SITE MARKER |
SENORX, INC. |
AMY BOUCLY |
K011371 |
05/04/2001 |
NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW |
SGMP CO., LTD. |
JANNA P TUCKER |
K011370 |
05/04/2001 |
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG |
SGMP CO., LTD. |
JANNA P TUCKER |
K011377 |
05/04/2001 |
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5 |
SGMP CO., LTD. |
JANNA P TUCKER |
K011613 |
05/25/2001 |
POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
JANNA P TUCKER |
K011474 |
05/14/2001 |
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
K011473 |
05/14/2001 |
SNAZZY2 |
SHOPRIDER INTL., INC. |
CHRIS TINSLEY |
K011476 |
05/14/2001 |
SOVEREIGN |
SHOPRIDER INTL., INC. |
CHRIS TINSLEY |
K011364 |
05/04/2001 |
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) |
SIEMENS HEARING INSTRUMENTS, INC. |
DAVE SLAVIN |
K011366 |
05/04/2001 |
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) |
SIEMENS HEARING INSTRUMENTS, INC. |
DAVE SLAVIN |
K011447 |
05/11/2001 |
IN SPACE 3D |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PRAVEEN NADKARNI |
K011487 |
05/15/2001 |
CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS |
SOMANETICS CORP. |
RONALD A WIDMAN |
K011339 |
05/02/2001 |
QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 |
SPACELABS BURDICK, INC. |
JOHN E GREENBAUM |
K011542 |
05/18/2001 |
SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D) |
SPECIALTY ULTRAVISION, INC. |
DEBBIE MCINTIRE |
K011580 |
05/22/2001 |
SIMPLICITY SOFT QD SILVER INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL S DOUGLAS |
K011410 |
05/08/2001 |
PARA 5X |
STRECK LABORATORIES, INC. |
PAUL KETTELSON |
K011319 |
05/01/2001 |
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX |
Stryker Endoscopy |
RYAN YEARSLEY |
K011381 |
05/07/2001 |
HUMMER IV MICRODEBRIDER SYSTEM |
STRYKER INSTRUMENTS |
ROBIN L ROWE |
K011499 |
05/15/2001 |
VISUALINE AMPHETAMINE DIPSTRIP ASSAY |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
K011466 |
05/14/2001 |
QED DIODE DETECTORS, MODELS 1112-1116 |
SUN NUCLEAR CORP. |
JIM MIXON |
K011332 |
05/02/2001 |
RF-IVD WIRELESS DOSIMETER-MODEL 1133 |
SUN NUCLEAR CORP. |
WILLIAM E SIMON |
K011588 |
05/23/2001 |
SURETONE |
SURETONE INTERNATIONAL |
MARYNA BURKE |
K011409 |
05/08/2001 |
SLT LASERPRO CTH HOLMIUM LASER SYSTEM |
SURGICAL LASER TECHNOLOGIES, INC. |
DAVIS WOODWARD |
K011583 |
05/23/2001 |
SPIKED WASHER |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K011334 |
05/02/2001 |
SYNTHES CURVED RECONSTRUCTION PLATE |
SYNTHES (USA) |
MATTHEW M HALL |
K011458 |
05/11/2001 |
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM |
SYNTHES (USA) |
MATTHEW M HULL |
K011335 |
05/02/2001 |
SYNTHS ONE-THIRD TUBULAR DCL PLATE |
SYNTHES (USA) |
MATTHEW M HULL |
K011528 |
05/17/2001 |
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 |
SYVA CO. |
SUSAN COLLINS |
K011347 |
05/02/2001 |
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 |
SYVA CO. |
SUSAN COLLINS |
K011620 |
05/25/2001 |
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 |
SYVA CO., DADE BEHRING, INC. |
CYNTHIA ARREDONDO |
K011605 |
05/24/2001 |
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 |
SYVA CO., DADE BEHRING, INC. |
SUSAN COLLINS |
K011396 |
05/07/2001 |
IBD-CHEK |
TECHLAB, INC. |
DAVID M LYERLY |
K011429 |
05/09/2001 |
MODEL 100 ACTIVITY MONITOR |
TELECOM MEDICAL, INC. |
THOMAS C WEHMAN |
K011543 |
05/18/2001 |
TENS CARE, MODEL XL-Y3 |
TENS CARE LTD. |
BERNARD JOHN TREMAINE |
K011444 |
05/11/2001 |
ANSPACH EMAX DRILL SYSTEM |
THE ANSPACH EFFORT, INC. |
WILLIAM E ANSPACH |
K011663 |
05/29/2001 |
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS |
THE BINDING SITE, LTD. |
JAY H GELLER |
K011662 |
05/29/2001 |
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL |
THE BINDING SITE, LTD. |
JAY H GELLER |
K011571 |
05/21/2001 |
TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE |
THE RX FILES CORP. |
YOLANDA SMITH |
K011497 |
05/15/2001 |
CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE |
TILLOTSON HEALTHCARE CORP. |
THOMAS N TILLOTSON |
K011685 |
05/31/2001 |
BISTITE II DC |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
K011567 |
05/21/2001 |
TORNIER TOTAL ELBOW PROSTHESIS |
TORNIER |
IRENE GOSSET |
K011434 |
05/10/2001 |
G7 AUTOMATED HPLC ANALYZER |
TOSOH MEDICS, INC. |
LOIS NAKAYAMA |
K011693 |
05/31/2001 |
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 |
TRUMPF MEDICAL SYSTEMS, INC. |
WILLIAM APPERSON |
K011488 |
05/15/2001 |
SPIRABRUSH CX BIOPSY INSTRUMENT |
TRYLON CORP. |
MARTIN LONKY |
K011563 |
05/21/2001 |
POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM |
U.O.P. RUBBER PRODUCTS SDN BHD |
CHUA BENG CHUAN |
K011418 |
05/09/2001 |
ULTRAGUIDE MR-GUIDE 3000 |
ULTRAGUIDE LTD. |
GEORGE MYERS |
K011574 |
05/22/2001 |
UNIPLANT DENTAL IMPLANT SYSTEM |
UNIVERSAL IMPLANT SYSTEMS, INC. |
FLOYD G LARSON |
K011683 |
05/30/2001 |
NURVO 9000 ENDOCAVITARY COILS |
USA INSTRUMENTS, INC. |
RONY THOMAS |
K011464 |
05/14/2001 |
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN |
VASCULAR INTERVENTION |
JENNIFER PAE RIGGS |
K011625 |
05/25/2001 |
VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) |
VASOCOR, INC. |
WALTER M ROSEBROUGH |
K011374 |
05/04/2001 |
JEWEL MPS |
VESTIL MANUFACTURING CORP. |
RICK MICHAEL |
K011676 |
05/30/2001 |
VIVAWAVE MICROWAVE SYSTEM |
VIVANT MEDICAL, INC. |
STEVEN KIM |
K011603 |
05/24/2001 |
VHS PEDIATRIC HIP SCREW SYSTEM |
WALTER ABENDSCHEIN, M.D. |
WALTER ABENDSCHEIN |
K011660 |
05/29/2001 |
WECK CARDIAC PACING WIRES |
WECK CLOSURE SYSTEMS |
BRIAN YOUNG |
K011561 |
05/21/2001 |
SEREINE EXTRA STRENGTH DAILY CLEANER |
WILSA, INC. |
SALLY COOK |
K011591 |
05/24/2001 |
ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE |
WILSON-COOK MEDICAL, INC. |
PAULA JOYCE |
K011510 |
05/16/2001 |
MULTI HI-FLO PNEU, WISAP #7080 |
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH |
HORST SEMM |
K011482 |
05/14/2001 |
DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
K011376 |
05/04/2001 |
EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200 |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
JANNA P TUCKER |
K011327 |
05/01/2001 |
DB1 EMBRYO FREEZE |
ZANDER MEDICAL SUPPLIES, INC. |
FRED ZANDER |
K011388 |
05/07/2001 |
ZOLL PAD |
ZOLL MEDICAL CORP. |
PAUL DIAS |
K011541 |
05/18/2001 |
ZOLL PAD WITH CPR AID |
ZOLL MEDICAL CORP. |
PAUL DIAS |