FDA-Registered Company Profile for EDWARDS LIFESCIENCES, LLC.
FDA-Supplied Establishment Information:
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
Establishment Status Code: A - Active
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
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
Other Establishment Information:
Establishment Phone:
Fax:
General Email:
Web Site: http://www.edwards.com
Company Brochure:
Keywords:
Company Description:
Services Offered:
About Us:
Differentiation:


FDA-Registered Products Offered by EDWARDS LIFESCIENCES, LLC.
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.:
 No products have been listed by this company.

Services Offered by the EDWARDS LIFESCIENCES, LLC.:
No services have been listed by this company.


Additional Contact Information for EDWARDS LIFESCIENCES, LLC.:
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.


  Company Name Address City State Zip Country
1 EDWARDS LIFESCIENCES AG ALTSAGENSTRASSE 14 HORW, LU 6048 SZ
2 EDWARDS LIFESCIENCES AG PARQUE INDUSTRIAL ITABO
KM. 18.5 CARR. SANCHEZ 		HAINA, SAN CRISTOBAL DR
3 EDWARDS LIFESCIENCES TECHNOLOGY SARL STATE RD. 402 N.KM 1.4 ANASCO PR 00610 US






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