Edwards Lifesciences Technology SARL
Anasco, PR, US
EDWARDS LIFESCIENCES TECHNOLOGY SARL appears in FDA device records in Anasco, PR. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Edwards Lifesciences Technology SARL carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Edwards Lifesciences Corporation of Puerto Ricorecall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2648045 | 2648045 | EDWARDS LIFESCIENCES TECHNOLOGY SARL | STATE ROAD 402, KM 1.4, Industrial Park, ANASCO, PR 00610 US | 2026 | and 22 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QMSAdjunctive Open Loop Fluid Therapy Recommender
- QAQAdjunctive Predictive Cardiovascular Indicator
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- KRACatheter, Continuous Flush
- DXECatheter, Embolectomy
- DYGCatheter, Flow Directed
- MJNCatheter, Intravascular Occluding, Temporary
- DQOCatheter, Intravascular, Diagnostic
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- GBXCatheter, Irrigation
- DQECatheter, Oximeter, Fiber-Optic
- DQYCatheter, Percutaneous
- MCWCatheter, Peripheral, Atherectomy
- GDJClamp, Surgical, General & Plastic Surgery
- DXCClamp, Vascular
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- FLLContinuous Measurement Thermometer
- DREDilator, Vessel, For Percutaneous Catheterization
- LDFElectrode, Pacemaker, Temporary
- DYBIntroducer, Catheter
- MUDOximeter, Tissue Saturation
- DSBPlethysmograph, Impedance
- KRBProbe, Thermodilution
- FGEStents, Drains And Dilators For The Biliary Ducts
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DRSTransducer, Blood-Pressure, Extravascular
- DXOTransducer, Pressure, Catheter Tip
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0338-2007 | Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75 | Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, containing the heparin coating) | Terminated | ||
| Z-0318-2007 | Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S | Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product. | Terminated | ||
| Z-0272-04 | Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA | Lot is being recalled because some of the kits contain an incorrect guidewire. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain