Omega Medical Imaging, Inc.
Omega Medical Imaging, Inc. holds FDA 510(k) medical device clearances, first cleared 1990, most recent 2010, with 4 FDA device recalls on record.
Top product codes for Omega Medical Imaging, Inc.
FDA recalls by Omega Medical Imaging, Inc.
- Z-0160-2024 — Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
- Z-0156-2024 — Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
- Z-2621-2017 — Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.
- Z-2734-2016 — 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Omega Medical Imaging, Inc.
- K100102 — CS-SERIES-FP
- K093572 — R650 QDASM COLLIMATOR
- K070834 — CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
- K062647 — E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
- K050092 — R605 FACS COLLIMETER
- K990055 — B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
- K970947 — B-350 CEILING MOUNTED C-POSITIONER
- K902005 — MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.