4 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Radiofrequency Grounding Pad, REF RF-DGP-L
FDA Enforcement
Class II
·Terminated·Abbott Medical·December 18, 2019
GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.
FDA Enforcement
Class II
·Terminated·General Electric Med Systems LLC·June 20, 2012
Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·November 20, 2013
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
FDA Enforcement
Class II
·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·September 5, 2012