7 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.
FDA Enforcement
Class II
·Terminated·Parker Laboratories, Inc.·November 5, 2014
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·August 15, 2012
TENSIVE Conductive Adhesive Gel, REF 016-401600
FDA Enforcement
Class II
·Ongoing·Natus Neurology Inc·March 27, 2024
natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
FDA Enforcement
Class II
·Ongoing·Natus Neurology Inc·March 27, 2024
Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
FDA Enforcement
Class II
·Ongoing·Parker Laboratories, Inc.·March 6, 2024
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
FDA Enforcement
Class II
·Terminated·Parker Laboratories, Inc.·May 16, 2018
Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
FDA Enforcement
Class II
·Ongoing·Parker Laboratories, Inc.·May 1, 2024