Ohio Medical Corporation

FDA Regulatory Profile

Ohio Medical Corporation appears in FDA public data with 4 recalls, 2 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1980-2025, Class II) was initiated on May 8, 2025. Its most recent 510(k) clearance was granted on May 2, 2008.

Summary

Total Recalls
4
510(k) Clearances
2
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1980-2025Class IIGCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-SMay 8, 2025
Z-0482-2022Class IIInstavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (modNovember 16, 2021
Z-2995-2018Class IIPortable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, MoAugust 14, 2018
Z-2410-2018Class IIVacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum reguMarch 12, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K081185MOBLVAC W.C.May 2, 2008
K062610CARE-E-VAC 3September 28, 2006