American Edwards Laboratories

Country not established

Devices: 90

What American Edwards Laboratories makes

American Edwards Laboratories manufactures rigid and flexible endoscopes, including small-diameter and angiographic models, as well as thermodilution catheters for hemodynamic monitoring. The company also produces pressure gauges, balloon calibrators, and dilation/sheath sets for vascular and urological procedures. Infusion devices, cassette readers, and catheter covers are part of its portfolio, supporting diagnostic and interventional applications.

The portfolio includes devices classified as Class I, Class II, Class III, and unclassified (U) under US regulations. Products are authorised via FDA pathways, including 510(k) clearances and PMA submissions. The manufacturer operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

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What American Edwards Laboratories makes

Catalogue90

Amer. Edwards Lab Flexiscope Obturator Ref K842323

Advancmed Eliminator Ref K803223

Percutaneous Nephrostomy Trocar Sys Ref K844090

Angioscopy Catheter Ref K832698

Nephrostomy Drainage Catheter & Stiffener Ref K845048

Percutaneous Angioscope Delivery Cath Ref K842799

Fogarty Flexible Probe Ref K812935

Swan-Ganz & Edslab Heparin Coated Cath. Ref K812563

Medtrac Vp Volumetric Infusion Pump Ref K864997

Transluminal Bipolar Pacing Probe Ref K813521

Fogarty-Chin Peripheral Dilation Cath Ref K832474

Swan-Ganz Flow-Directed Multipur. Cath. Ref K803058

Angioscopy Catheter Ref K834547

Xenon Light Source For Endoscopic Procedures Ref K863986

Chin-Fogarty Inflation Device Ref K863596

Fogarty Softjaw 6mm Spring Clip, #614-06 Ref K810162

Ureteral Dilator & Ureteral Stone Dislodger Ref K850954

Advancemed Ccu Documentor Ref K803222

Pericardial Patch Ref K833763

American Edwards Labs Flexiscope Ref K841607

Fogarty Ballon Angioplasty Catheters Ref K803057

Disposable Blades For Arthroscopic Surgical Device Ref K863604

Swan-Ganz Heparin Coated, Etc. Catheter Ref K811411

Rigid Endoscope Ref K853514

Mechanical Inflation Device Ref K862547

Contiuous Wave Doppler Ultrasound Ref K802670

Ureteral Dilator Ref K852324

Advancemed Holter Recorders Ref K803224

Coaxial Balloon Urethral Dilator Ref K833690

Hybrid Peripheral Dilation Catheter Ref K834220

Diaflex Occlusion Balloon Catheter Ref K850790

Amer. Edwards Lab Diaflex Ureteral Dila Ref K842639

Cardiac 1000 Tm Ref K811094

Right Ventricular Ejection Fraction- Ref K842105

Paper Chart Recorder Ref K811254

Amer. Edwards Lab Flexiscope Ref K842410

Thermodilution Cardiac Output Computer, Mod. Com-2 Ref K872529

Modification Of Carpentier-Edwards Bioprosthesis Ref K864155

Nephrostomy Guidewire Sheath Ref K845047

Garren Gastric Bubble Ref P840025