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FDA-Registered Company Profile for EDWARDS LIFESCIENCES, LLC.
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| FDA-Supplied Establishment Information: |
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| Establishment Registration Number: |
2015691 |
| Company Name: |
EDWARDS LIFESCIENCES, LLC. |
| Address: |
ONE EDWARDS WAY |
| Address 2: |
|
| City: |
IRVINE |
| State |
CA |
| Zip / Postal Code: |
92614 |
| County: |
ORANGE |
| Country: |
US |
| Establishment Operation Code(s): |
AA - Initial Distributor
MM - Manufacturer
MS - Specification Developer
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| Establishment Status Code: |
A -
Active
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Year of Most Recent Initial
or Annual Registration: |
2007 |
| FDA-Supplied Owner/Operator Information: |
| Owner/Operator Number: |
9040666 |
| Company Name: |
EDWARDS LIFESCIENCES, LLC.
|
| Address: |
ONE EDWARDS WAY |
| Address 2: |
|
| City: |
IRVINE |
| State: |
CA |
| Zip / Postal Code: |
92614 |
| Country: |
US |
| Owner/Operator Phone: |
949-250-2500
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| FDA-Supplied Official Correspondent Information: |
| Official Correspondent Name: |
MR. SCOTT BEGGINS |
| Company Name: |
EDWARDS LIFESCIENCES, LLC. |
| Address: |
ONE EDWARDS WAY |
| Address 2: |
|
| City: |
IRVINE |
| State: |
CA |
| Zip / Postal Code: |
92614 |
| Country: |
US |
| Official Corespondent Phone Number: |
949-250-2698
|
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| Other Establishment Information: |
| Establishment Phone: |
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| Fax: |
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| General Email: |
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| Web Site: |
http://www.edwards.com
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| Company Brochure: |
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| Keywords: |
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| Company Description: |
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| Services Offered: |
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| About Us: |
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| Differentiation: |
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FDA-Registered Products Offered by EDWARDS LIFESCIENCES, LLC.
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|
Common Device Name |
Proprietary Device Name |
| 1 |
ANGIOSCOPE |
ANGIOSCOPE |
| 2 |
ANGIOSCOPIC IRRIGATION PUMP |
PUMP, WITHDRAWAL/INFUSION |
| 3 |
ANGIOSCOPIC VALVULOTOME |
VALVULOTOME |
| 4 |
ANNULOPLASTY RING |
RING, ANNULOPLASTY |
| 5 |
ARTERIAL BLOOD SAMPLING KIT |
ARTERIAL BLOOD SAMPLING KIT |
| 6 |
BILIARY STENT |
LIFESTENT BILIARY STENT |
| 7 |
BIOPROSTHETIC HEART VALVE |
HEART-VALVE, REPLACEMENT |
| 8 |
CATHETER, CONTINUOUS FLUSH |
CATHETER, CONTINUOUS FLUSH |
| 9 |
CATHETER, OXIMETER, FIBEROPTIC |
CATHETER, OXIMETER, FIBEROPTIC |
| 10 |
CBD ENDOSCOPE |
CBD ENDOSCOPE |
| 11 |
CENTRAL VENOUS CATHETER KIT |
MULTIPLE PRODUCT NAMES |
| 12 |
CO-SET |
CO-SET |
| 13 |
DIAGNOSTIC MONITORS |
DIAGNOSTIC MONITORS |
| 14 |
DISPOSABLE PRESSURE DOME |
DISPOSABLE PRESSURE DOME |
| 15 |
ELECTRODE, PACEMAKER, PERMANENT |
ELECTRODE, PACEMAKER, PERMANENT |
| 16 |
ELECTRODE, PACEMAKER, TEMPORARY |
ELECTRODE, PACEMAKER, TEMPORARY |
| 17 |
EMBOLECTOMY CATHETER |
CATHETER, EMBOLECTOMY |
| 18 |
ENDOSCOPIC STONE RETRIEVAL BASKET |
DISLODGER, STONE, BASKET, URETERAL, METAL |
| 19 |
HANDLE |
INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
| 20 |
HOLDER, HEART-VALVE, PROSTHESIS |
HOLDER, HEART-VALVE, PROSTHESIS |
| 21 |
INTRODUCER KIT |
MULTIPLE PRODUCT NAMES |
| 22 |
INTRODUCER KITS, VARIOUS TYPES |
INTRO-FLEX INTRODUCERS |
| 23 |
JANKE-BARRON HEART SUPPORT |
JANKE-BARRON HEART SUPPORT |
| 24 |
MANUAL SURGICAL INSTRUMENT |
MITRAL VALVE CALIPER |
| 25 |
MECHANICAL HEART VALVE |
HEART-VALVE, MECHANICAL |
| 26 |
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
| 27 |
OCCLUSION CATHETER |
OCCLUSION CATHETER |
| 28 |
PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) |
CATHETER, PERIPHERAL, ATHERECTOMY |
| 29 |
SET, ADMINISTRATION, INTRAVASCULAR |
SET, ADMINISTRATION, INTRAVASCULAR |
| 30 |
SIDE BRANCH OCCLUSION SYSTEM |
SIDE BRANCH OCCLUSION SYSTEM |
| 31 |
SIZER, HEART-VALVE, PROSTHESIS |
SIZER, HEART-VALVE, PROSTHESIS |
| 32 |
STERILE THERAPEUTIC CATHETER |
MULTI-MED DOUBLE LUMEN CATHETER, SINGLE LUMEN INFUSION CATH |
| 33 |
STOPCOCK, I.V. SET |
STOPCOCK, I.V. SET |
| 34 |
STRIP CHART RECORDER |
EDWARDS CRITICAL-CARE STRIP CHART RECORDER |
| 35 |
TISSUE, HEART-VALVE |
TISSUE, HEART-VALVE |
| 36 |
TRAY, SURGICAL, INSTRUMENT |
TRAY, SURGICAL, INSTRUMENT |
| 37 |
TUBING, FLUID DELIVERY |
TUBING, FLUID DELIVERY |
| 38 |
VARIOUS PATCH, PERICARDIAL PRODUCTS |
PATCH, PERICARDIAL |
| 39 |
VARIOUS CATHETER, FLOW DIRECTED PRODUCTS |
SWAN-GANZ CATHETER |
| 40 |
VARIOUS TYPES OF STERILE CATHETERS |
EDSLAB CATHETERS |
| All FDA-Registered products for this company are displayed above. |
Other Products Offered by EDWARDS LIFESCIENCES, LLC.:
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No products have been listed by this company.
Services Offered by the EDWARDS LIFESCIENCES, LLC.:
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No services have been listed by this company. |
Additional Contact Information for EDWARDS LIFESCIENCES, LLC.:
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| There is no additional contact information for this company. |
Companies Related to EDWARDS LIFESCIENCES, LLC.
Our records indicate that the following companies are related by ownership.
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