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DISLODGER, STONE, BASKET, URETERAL, METAL
 Request for Information Form |
 Contact Information
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| Company Name | EDWARDS LIFESCIENCES, LLC. |
| Address | ONE EDWARDS WAY |
| City, State, Zip | IRVINE, CA 92614 |
| Country | US |
| FDA Owner/Operator Phone | 949-250-2500 |
| FDA Medical Specialty Code | GU - Gastroenterology/Urology |
| FDA Product Code | FFL |
| FDA Classification Name | DISLODGER, STONE, BASKET, URETERAL, METAL |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 876.4680 |
| FDA Common Generic Name | ENDOSCOPIC STONE RETRIEVAL BASKET |
| FDA Proprietary Device Name | DISLODGER, STONE, BASKET, URETERAL, METAL |
| FDA Owner / Operator Number | 9040666 |
| FDA Owner / Operator Name | EDWARDS LIFESCIENCES, LLC. |
| FDA Establishment Registration Number | 2015691 |
| FDA Registered Establishment Name | EDWARDS LIFESCIENCES, LLC. |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 06-26-02 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of EDWARDS LIFESCIENCES, LLC.
Our records indicate that the following medical device companies may manufacture a similar device.| Company Name / Address / Phone | Proprietary Device Name | Common Generic Device Name | |
| 1 | ACTEON, INC. 124 GAITHER DR. SUITE 140 MOUNT LAUREL, NJ 08054 US 33-556-349139 / 856-222-9988 40 |
ENDOSCOPY GRASPING FORCEPS | ENDOSCOPY GRASPING FORCEPS |
| 2 | ALLWIN MEDICAL DEVICES, INC. 3305 E. MIRALOMA AVENUE SUITE 180 ANAHEIM, CA 92806 US 714-572-1709 / 714-572-1709 |
URETERAL STONE BASKET | URETERAL STONE BASKET |
| 3 | AMECO MEDICAL INDUSTRIES INDUSTRIAL AREA B4-PLOT 119 EAST 10TH OF RAMADAN CITY, EG 20-15-383067 / 20-15-383067 |
AMECATH URETERAL STONE DISLODGER | URETERAL STONE DISLODGER |
| 4 | ANNEX MEDICAL, INC. 6018 BLUE CIRCLE DR. MINNETONKA, MN 55343 US 952-942-7576 / 952-942-7576 |
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| 5 | AOMORI OLYMPUS CO., LTD. 2-248-1, OKKONOKI KUROISHI-SHI, AOMORI-KEN, 036-0357 JA / 484-896-5688 |
FG SERIES OF GRASPING FORCEPS | VARIOUS MODELS OF GRASPING DEVICES AND FORCEPS |
| 6 | BOSTON SCIENTIFIC CORPORATION 780 BROOKSIDE DRIVE SPENCER, IN 47460 US 508-652-5594 / 508-652-5594 |
SEGURA BASKETS, HELICAL BASKETS | VARIOUS TYPES OF STONE RETRIEVAL BASKETS |
| 7 | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US 908-277-8000 / 908-277-8513 |
MULTIPLE | VARIOUS TYPES OF STONE BASKETS |
| 8 | C.R. BARD, INC. 1211 MARY MAGNAN BLVD. MADISON, GA 30650 US 908-277-8000 / 908-277-8513 |
BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE, MULTIPLE | URETERAL STONE BASKET, DISLODGER, EXTRACTOR, MULTIPLE |
| 9 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN RD. MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-6442 |
PFISTER-SCHWARTZ STONE RETRIEVERS | VARIOUS SIZES & STYLES OF SOTNE RETRIEVERS |
| 10 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1240 WAUKEGAN RD. MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-6442 |
PFISTER-SCHWARTZ STONE RETRIEVERS | VARIOUS SIZES & STYLES OF SOTNE RETRIEVERS |
| 11 | COLOPLAST MANUFACTURING FRANCE, SAS USINE DU PONTET BP 89 SARLAT, 24203 FR 45-49-111111 / 612-302-4992 |
PORGES DORMIA | STONE BASKET |
| 12 | COOK ENDOSCOPY 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. WINSTON-SALEM, NC 27105 US 336-744-0157 / 336-744-0157 |
WEB & MEMORY STONE EXTRACTION AND RETRIEVAL BASKETS | STONE EXTRACTION BASKET |
| 13 | COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK LIMERICK, EI 353-613-34440 / 353-613-34440 |
STONE EXTRACTORS/BASKETS | VARIOUS TYPES OF STERILE & NON STERILE STONE EXTRACTORS |
| 14 | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. SPENCER, IN 47460 US 812-829-4891 / 812-829-4891 |
VARIOUS SIZES OF STERILE AND NON-STERILE BASKETS | |
| 15 | COOK, INC. 750 DANIELS WAY PO BX 489 BLOOMINGTON, IN 47402 US 812-339-2235 / 812-339-2235 |
BILLARY STONE REMOVAL KIT | STERILE BILLARY STONE REMOVAL KIT |
| 16 | ERCHINGER CHIRURGISCHE INSTRUMENTE RUDOLF-DIESEL-STRASSE 20 TUTTLINGEN, D-78532 GM / 011-49-7461966250 |
MULTIPLE | URETRAL INSTRUMENTS |
| 17 | GIMMI GMBH CARL-ZEISS-STRASSE 6 TUTTLINGEN, D-78532 GM / 49-746-1965900 |
MULTIPLE | BASKET |
| 18 | GREENWALD SURGICAL CO., INC. 2688 DEKALB ST. LAKE STATION, IN 46405 US 219-962-1604 / 219-962-1604 |
JOHNSON, ROBINSON, COUNCILL | VARIOUS TYPES OF URETERAL STONE DISLODGERS |
| 19 | GYRUS ACMI, INC. 6765 WEDGWOOD RD. MAPLE GROVE, MN 55311 US 011-44-189219750 / 508-804-2739 |
VARIOUS STONE BASKETS | DISLODGER, STONE, BASKET, URETERAL |
| 20 | HANOVER MEDICAL SYSTEMS, INC. 11915 53RD ST. N.E. ALBERTVILLE, MN 55301 US / 612-497-1774 |
DISPOSABLE BASKET SNARE | STERILE BASKET SNARE |
| 21 | HOBBS MEDICAL, INC. 8 SPRING ST. STAFFORD SPRINGS, CT 06076 US 860-684-5875 / 860-684-5875 |
HOBBS MEDICAL STONE BASKETS | STONE WIRE RETRIEVAL BASKETS |
| 22 | HORIZONS INTL. CORP. ZETA FREE ZONE PARK LA VALENCIA HEREDIA, CS 506-261-9114 / 506-261-9114 |
HORIZONS ENDOSCOPIC RETRIEVAL BASKETS | GI RETRIEVAL BASKETS |
| 23 | MEDICON, E.G. GAENSAECKER 15 TUTTLINGEN, D-78532 GM 49-746-220090 / 49-746-220090 |
DISLODGER, STONE, BASKET, URETERAL, METAL#GASTROENTEROLOGY-UROLOGY | URETERAL STONE DISLODGER |
| 24 | OLYMPUS MEDICAL SYSTEMS CORPORATION 2951 ISHIKAWA-CHO HACHIOJI-SHI, 192-8507 JA / 484-896-5688 |
GRASPING FORCEPS | GRASPING FORCEPS |
| 25 | OMNITECH SYSTEMS, INC. 456 SOUTH CAMPBELL, BLDG. C VALPARAISO, IN 46385 US 219-531-5532 / 219-531-5532 |
FLAT WIRE BASKET, GRASPER, NITINOL WIRE BASKET | STERILE STONE DISLODGERS |
| 26 | PERCUTANEOUS SYSTEMS, INCORPORATED 1300 CRITTENDEN LANE SUITE 101 MOUNTAIN VIEW, CA 94043 US 650-969-8800 / 650-969-8800 204 |
ACCORDION UROLOGICAL OCCLUDING GUIDEWIRE | ACCORDION |
| 27 | PLUROMED, INC. 25-K OLYMPIA AVENUE WOBURN, MA 01801 US 781-932-0574 / 781-932-0574 |
BACKSTOP FOR KIDNEY STONE REMOVAL | BACKSTOP |
| 28 | PRODUCTOS PARA EL CUIDADO DE LA SALUD KM. 7 CARRETERA INTERNACIONAL NOGALES, SONORA, MX 908-277-8000 / 908-277-8513 |
MULTIPLE | VARIOUS TYPES OF STONE BASKETS |
| 29 | R & D TECH, INC. 42 TAVERN RD. GROTON, MA 01450 US 978-448-3567 / 978-448-3567 |
UROLOGY STONE BASKET | VARIOUS TYPES OF STONE BASKETS & GRASPERS |
| 30 | RAND-WHITNEY CONTAINER NORTHEAST LLC 216 AIRPORT RD. ROCHESTER, NH 03867 US 508-890-7038 / 508-890-7003 |
BRAUN THERMO SCAN | THERMO SCAN,EAR THERMOMETER |
| 31 | RICHARD WOLF GMBH PFORZHEIMER STR. 32 KNITTLINGEN, 75438 GM 011-49-704335-0 / 847-913-1113 380 |
DISLODGER, STONE, BASKET, URETERAL, METAL | STONE DISLODGER |
| 32 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. VERNON HILLS, IL 60061 US 011-49-704335-0 / 847-913-1113 380 |
DISLODGER, STONE, BASKET, URETERAL, METAL | STONE DISLODGER |
| 33 | SOUTH CANAL INTL. CO., LTD. 6F, NO. 176, SEC. 3, KING-HWA ROAD TAINAN, 70055 TW 886-6-2293151 / 886-3-5208829 |
DISLODGER, STONE, BASKET, URETERAL, METAL | VARIOUS TYPES |
| 34 | STERILMED, INC. 11400 73RD AVE. NORTH, #100 MAPLE GROVE, MN 55369 US 763-488-3400 / 763-488-3410 |
DISLODGER, STONE, BASKET, URETERAL, METAL | REPROCESSED STONE RETRIEVAL BASKET |
| 35 | SURGIMEDIK HEALTHCARE INDIA PVT. LTD. 53-CD, KANDIVALI INDUSTRIAL ESTATE, CHARKOP, KANDIVALI (W) MUMBAI, MAHARASTRA, 400 104 IN 91-286-09401 / 91-222-8609401 |
STONE BASKET | DISLODGER, STONE, BASKET, URETERAL |
| 36 | TELEFLEX MEDICAL AVE. INDUSTRIAS NO.5954 PARQUE INDUSTRIAL FINSA NUEVO LAREDO, TAMAULIPAS, 88275 MX 919-544-8000 / 919-433-4829 |
PORGES DORMIA | STONE BASKET |
| 37 | TELEFLEX MEDICAL 4024 STIRRUP CREEK DR. SUITE 720 DURHAM, NC 27703 US 919-544-8000 / 919-433-4829 |
MULTIPLE METAL URETERAL BASKET STONE DISLODGERS | VARIOUS TYPES OF METAL URETERAL BASKET STONE DISLODGERS |
| 38 | TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. HUDSON, MA 01749 US 978-567-9033 / 978-567-9033 |
DISPOSABLE RETRIEVAL BASKET | DISPOSABLE RETRIEVAL BASKET |
| 39 | WITTE GMBH CHIRURGISCHE INSTRUMENTE MANKHAUSER STRASSE 1 SOLINGEN, D-42699 GM / 021-233-1077 |
MULTIPLE | VARIOUS TYPES OF DISLODGERS |
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