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CBD ENDOSCOPE
 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 | FBN |
| FDA Classification Name | CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 876.1500 |
| FDA Common Generic Name | CBD ENDOSCOPE |
| FDA Proprietary Device Name | CBD ENDOSCOPE |
| 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 | AIZU OLYMPUS CO., LTD. 500 AZA MURANISHI OOAZA-IIDERA MONDEN-CHO AIZUWAKAMATSU-SHI FUKUSHIMA, 965-8520 JA / 484-896-5688 |
VARIOUS MODELS OF CHOLEDOCHOSCOPES & ACCESSORIES | CHOLEDOCHOSCOPES AND ACCESSORIES |
| 2 | APPLIED MEDICAL RESOURCES CORP. 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA, CA 92688 US 949-713-8000 / 949-713-8000 8326 |
CYSTIC DUCT ACCESS KIT | CYSTIC DUCT ACCESS KIT |
| 3 | FUJINON CORPORATION 1-324, UETAKE KITA-KU SAITAMA, 331-9624 JA 81-486-682095 / 81-48-6682095 |
FUJINON CHOLEDOCHOSCOPES & ACCESSORIES | VARIOUS CHOLEDOCHOSCOPES & ACCESSORIES |
| 4 | FUJINON, INC. 10 HIGH POINT DR. WAYNE, NJ 07470 US 81-486-682095 / 973-633-5600 210 |
FUJINON CHOLEDOCHOSCOPE & ACCESSORIES | VARIOUS CHOLEDOCHOSCOPES & ACCESSORIES |
| 5 | GYRUS ACMI, INC. 300 STILLWATER P.O.BOX 1971 STAMFORD, CT 06902 US 011-44-189219750 / 508-804-2739 |
USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS | CHOLEDOCHOSCOPE |
| 6 | KARL STORZ ENDOSCOPY-AMERICA, INC. 91 CARPENTER HILL RD. CHARLTON, MA 01507 US 49-74-617080 / 800-421-0837 4201 |
CHOLEDOCHOSCOPE | VARIOUS MODELS OF CHOLEDOCHOSCOPES |
| 7 | KARL STORZ GMBH & CO. KG MITTELSTRASSE 8 TUTTLINGEN, 78532 GM 49-74-617080 / 800-421-0837 4201 |
KARL STORZ CHOLEDOCHOSCOPE | VARIOUS MODELS OF CHOLEDOSCHOSCOPE |
| 8 | LINVATEC CORP. 11311 CONCEPT BLVD. LARGO, FL 33773 US 727-399-5234 / 727-399-5334 |
CHOLEDOCHOSCOPE | CHOLEDOCHOSCOPE |
| 9 | MASHIKO FACTORY 858 OAZA-HANAWA, MASHIKO-MACHI HAGA-GUN TOCHIGI, 321-4292 JA 81-3-39605151 / 800-431-5880 2064 |
PENTAX CHOLEDOCHOSCOPE, VARIOUS MODELS | PENTAX CHOLEDOCHOSCOPE |
| 10 | MTP MEDICAL TECHNICAL PROMOTION GMBH TAKE-OFF GEWERBE PARK 46 NEUHAUSEN OBECK, D-78579 GM 49-74-617080 / 310-348-4201 |
KARL STORZ CHOLEDOCHOSCOPE | CHOLEDOCHOSCOPE |
| 11 | OLYMPUS MEDICAL SYSTEMS CORPORATION 2951 ISHIKAWA-CHO HACHIOJI-SHI, 192-8507 JA / 484-896-5688 |
CHOLEDOCHOSCOPE, FLEXIBLE OR RIGID (MULTIPLE BRANDS) | CHOLEDOCHOSCOPES & ACCESSORIES |
| 12 | OLYMPUS WINTER & IBE GMBH KUEHNSTRASSE 61 HAMBURG, 22045 GM 494-066-9660 / 484-896-5688 |
MULTIPLE | CHOLEDOCHOSCOPE |
| 13 | PENTAX CORP. 2-36-9 MANENO-CHO ITABASHI-KU TOKYO, 174-8639 JA 81-3-39605151 / 201-571-2300 2064 |
VARIOUS MODELS | PENTAX CHOLEDOCHOSCOPE |
| 14 | PENTAX MEDICAL COMPANY 102 CHESTNUT RIDGE RD. MONTVALE, NJ 07645 US 800-431-5880 / 201-571-2300 2064 |
VARIOUS MODELS | PENTAX CHOLEDOCHOSCOPE |
| 15 | PENTAX SOUTHERN REGION SERVICE CENTER 8934 KIRBY DR. HOUSTON, TX 77054 US 800-431-5880 / 800-431-5880 2064 |
PENTAX CHOLEDOCHOSCOPES, VARIOUS MODELS | CHOLEDOCHOSCOPE |
| 16 | PENTAX TOHOKU CO., LTD. 30-2 OKADA, AZA-SHIMOMIYANO, TSUKIDATE KURIHARA-SHI, MIYAGI, 987-2203 JA 81-3-39605151 / 201-571-2300 2064 |
VARIOUS MODELS | PENTAX CONFOCAL SCOPE |
| 17 | PENTAX WEST COAST SERVICE CENTER 10410 PIONEER BLVD., UNIT 2 SANTA FE SPRINGS, CA 90670 US 800-431-5880 / 800-431-5880 2064 |
VARIOUS MODELS | PENTAX CHOLEDOCHOSCOPE |
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