Oakworks Inc

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0730-2024Class IIUltrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An UltrDecember 5, 2023
Z-0727-2024Class IIUltrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination tableDecember 5, 2023
Z-0729-2024Class IIUltrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-SpDecember 5, 2023
Z-0728-2024Class IIUltrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An UltrDecember 5, 2023
Z-1239-2022Class IIOakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCSApril 21, 2022
Z-1238-2022Class IIPX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19April 21, 2022
Z-2349-2021Class IIVascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use:June 29, 2021
Z-1411-2019Class IIOAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: OakworksMay 2, 2019
Z-0703-2018Class IIFoot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWOJuly 31, 2017