Atrium Medical Corporation
Atrium Medical Corporation holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2024, with 153 FDA device recalls on record.
Top product codes for Atrium Medical Corporation
FDA recalls by Atrium Medical Corporation
10 most recent of 153- Z-3111-2026 — Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
- Z-3113-2026 — Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
- Z-3112-2026 — Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);
- Z-0024-2025 — iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
- Z-2010-2024 — FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
- Z-1970-2024 — ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
- Z-1979-2024 — ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Z-2003-2024 — FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
- Z-2015-2024 — FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
- Z-1966-2024 — ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
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 Atrium Medical Corporation
- K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft
- K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
- K151386 — C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
- K151437 — ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
- K130142 — FLIXENE IFG VASCULAR GRAFT
- K110110 — ATRIUM CENTRILFX MESH
Data sourced from openFDA. This site is unofficial and independent of the FDA.