Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of GetingeLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Atrium Medical with 153 device recalls and 69 510(k) clearances. The most recent is a device recall dated Aug 7, 2026: Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 1….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 7, 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(803Class II · An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | Device recalls |
| Aug 7, 2026 | Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);Class II · An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | Device recalls |
| Aug 7, 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(Class II · An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | Device recalls |
| Sep 9, 2024 | iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616Class II · There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. | Device recalls |
| May 3, 2024 | ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftClass II · Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two | Device recalls |
| May 3, 2024 | ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graftClass II · Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two | Device recalls |
| May 3, 2024 | ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass II · Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two | Device recalls |
| May 3, 2024 | ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass II · Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two | Device recalls |
| Mar 28, 2024 | Advanta VXT Vascular Graft, Flixene Vascular GraftK231972 · DSY | 510(k) clearances |
| Sep 3, 2021 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest DrainK201305 · CAC | 510(k) clearances |
| Oct 22, 2015 | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR MosaicK151386 · FTL | 510(k) clearances |
| Aug 27, 2015 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh PlugK151437 · FTL | 510(k) clearances |
| Mar 15, 2013 | FLIXENE IFG VASCULAR GRAFTK130142 · DSY | 510(k) clearances |
| Feb 28, 2013 | EDRAIN CHEST DRAINAGE SYSTEMK130131 · BTA | 510(k) clearances |
| Aug 17, 2012 | ATRIUM FLIXENE IFG VASCULAR GRAFTK122138 · DSY | 510(k) clearances |
| Apr 26, 2012 | C-QUR RPM MESHK121070 · FTL | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
