9 results
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28ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical CFPM 301 Imaging Table OAKWORKS¿ Medical CFPM 400 Imaging Table OAKWORKS¿ Medical CFPM 401 Imaging Table OAKWORKS¿ Medical CFPMB 301 Bariatric Imaging Table OAKWORKS¿ Medical CFUR 301 Urology Table OAKWORKS¿ Medical CFUR 401 Urology Table OAKWORKS¿ Medical CFLU 401 Lithotripsy/Urology Table
FDA Enforcement
Class II
·Terminated·Oakworks Inc·March 7, 2018
OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such as spinal injections, vertebroplasty procedures and other pain management procedures. The CFLU Table is designed for Lithotripsy and Urology procedures. It is intended to be operated by a healthcare professional in a medical environment. No special training is required but a review of the Safety Instructions is important for the safety of the operator and patient.
FDA Enforcement
Class II
·Terminated·Oakworks Inc·May 29, 2019
Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219
FDA Enforcement
Class II
·Terminated·Oakworks Inc·September 1, 2021
Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
FDA Enforcement
Class II
·Ongoing·Oakworks Inc·January 24, 2024
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
FDA Enforcement
Class II
·Ongoing·Oakworks Inc·January 24, 2024
Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
FDA Enforcement
Class II
·Ongoing·Oakworks Inc·January 24, 2024
Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}
FDA Enforcement
Class II
·Ongoing·Oakworks Inc·January 24, 2024
PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
FDA Enforcement
Class II
·Terminated·Oakworks Inc·June 15, 2022
Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
FDA Enforcement
Class II
·Terminated·Oakworks Inc·June 15, 2022