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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Uni-Directional Navigation Catheter, NAV, F
Biosense Webster Inc
D139402
In Commercial Distribution

  • 10846835017076 ()
D139402

  • Cardiac radio-frequency ablation system catheter
Uni-Directional Navigation Catheter, NAV, D
Biosense Webster Inc
D139401
In Commercial Distribution

  • 10846835017045 ()
D139401

  • Cardiac radio-frequency ablation system catheter
TX eco EXT Cable
Biosense Webster Inc
D135703
In Commercial Distribution

  • 10846835016796 ()
D135703

  • Electrical-only medical device connection cable, reusable
Bi-Directional Navigation Catheter, NAV, D-F
Biosense Webster Inc
D139505
In Commercial Distribution

  • 10846835016758 ()
D139505

  • Cardiac radio-frequency ablation system catheter
Bi-Directional Navigation Catheter, NAV, F-J
Biosense Webster Inc
D139504
In Commercial Distribution

  • 10846835016741 ()
D139504

  • Cardiac radio-frequency ablation system catheter
Bi-Directional Navigation Catheter, NAV, J-J
Biosense Webster Inc
D139503
In Commercial Distribution

  • 10846835016734 ()
D139503

  • Cardiac radio-frequency ablation system catheter
Bi-Directional Navigation Catheter, NAV, F-F
Biosense Webster Inc
D139502
In Commercial Distribution

  • 10846835016727 ()
D139502

  • Cardiac radio-frequency ablation system catheter
Bi-Directional Navigation Catheter, NAV, D-D
Biosense Webster Inc
D139501
In Commercial Distribution

  • 10846835016710 ()
D139501

  • Cardiac radio-frequency ablation system catheter
Cath to Generator CBL Sterile
Biosense Webster Inc
D133701
In Commercial Distribution

  • 10846835010121 ()
D133701

  • Electrical-only medical device connection cable, reusable
The Model 3150 IPG is the next generation Implantable Pulse Generator (IPG). It contains electronics and a battery that are sealed inside a titanium case. The Model 3150 is smaller in size than the previous model (3028) and eliminates the need of an Inspire respiratory sensing lead by having a built-in sensing accelerometer in the Model 3150 generator itself. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connects to the Inspire stimulation lead. The Model 3150 introduces improved communication speed between the IPG and the external products along with enhanced security. The Inspire system stimulates the hypoglossal nerve, synchronous with the patient’s respiration cycle using closed loop sensing technology. The timed stimulation elicits a neuromuscular response from the base of the tongue thereby preventing upper airway collapse that causes airflow obstruction in many OSA patients. The Model 3150 IPG will also allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-015-001
In Commercial Distribution

  • 10855728005960 ()
3150

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
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