Company ยท US
Ohio Medical Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2008. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2025 | Ohio Medical Corporation GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S Open, Classified |
CAW | K162433 |
| Nov 16, 2021 | Ohio Medical Corporation Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 7 Open, Classified |
BTA | K933902 |
| Sep 7, 2018 | Ohio Medical Corporation Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC
The care-e-(R)3 is a portable medical aspirator used to suction Terminated |
BTA | K062610 |
| Mar 12, 2018 | Ohio Medical Corporation Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU)
Product Usage:
The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the Terminated |
KDP | None listed |
| Dec 29, 2010 | Ohio Medical Corporation Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 758000
The device is a portable aspirator to help evacuate saliva, Terminated |
BTA | K062610 |
| Jun 7, 2010 | Ohio Medical Corporation NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 769709. Terminated |
BTA | K081185 |
| Jun 7, 2010 | Ohio Medical Corporation MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negative pressure for the application of wound drainage; Ohio Medical Corporation, Gurnee, IL 60031; Models 769600 ( Terminated |
BTA | K081185 |
| Oct 29, 2009 | Ohio Medical Corporation Vacuum Collection Bottle, 1 gallon (3200 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0302-600 (6700-209-500); the bottles are sold alone and with various cap & float assemblies:
032 Terminated |
KDQ | None listed |
| Oct 29, 2009 | Ohio Medical Corporation Vacuum Collection Bottle, 1/2 gallon (1300 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0301-600 (6700-0206-500); the bottles are sold alone and with various cap & float assemblies in Terminated |
KDQ | None listed |