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Atrium Medical Corporation

145 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 recall (Z-0024-2025)Atrium Medical Corporation2024-10-07
ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1951-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1952-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1953-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1954-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1955-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1956-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1957-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1958-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1959-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1960-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1961-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1962-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1963-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1964-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1965-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1966-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1967-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1968-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1969-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1970-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1971-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1972-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1973-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1974-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1975-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1976-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1977-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1978-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1979-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1980-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1981-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1982-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1983-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1984-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1985-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1986-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1987-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1988-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1989-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1990-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1991-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1992-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1993-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1994-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1995-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1996-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1997-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1998-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1999-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-2000-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-2001-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft recall (Z-2002-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft recall (Z-2003-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft recall (Z-2004-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft recall (Z-2005-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft recall (Z-2006-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft recall (Z-2007-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft recall (Z-2008-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft recall (Z-2009-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft recall (Z-2010-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft recall (Z-2011-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft recall (Z-2012-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft recall (Z-2013-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft recall (Z-2014-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft recall (Z-2015-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft recall (Z-2016-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft recall (Z-2017-2024)Atrium Medical Corporation2024-06-04
FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft recall (Z-2018-2024)Atrium Medical Corporation2024-06-04
Atrium Oasis Drain Single W / AC, Part No. 3600-100 recall (Z-0621-2024)Atrium Medical Corporation2023-12-28
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036. recall (Z-0484-2024)Atrium Medical Corporation2023-12-02
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGL recall (Z-0485-2024)Atrium Medical Corporation2023-12-02
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W recall (Z-0486-2024)Atrium Medical Corporation2023-12-02
Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, recall (Z-0316-2024)Atrium Medical Corporation2023-11-16
Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; ( recall (Z-0317-2024)Atrium Medical Corporation2023-11-16
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN recall (Z-0318-2024)Atrium Medical Corporation2023-11-16
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring recall (Z-0291-2024)Atrium Medical Corporation2023-11-11
Atrium Pneumostat Chest Drain Valve, Part Number 16100 recall (Z-1302-2023)Atrium Medical Corporation2023-03-30
Express Mini 500 Dry Seal Chest Drain, Part Number 16400 recall (Z-1303-2023)Atrium Medical Corporation2023-03-30
Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000 recall (Z-0235-2023)Atrium Medical Corporation2022-11-15
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 recall (Z-1076-2022)Atrium Medical Corporation2022-05-18
iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 8 recall (Z-1077-2022)Atrium Medical Corporation2022-05-18
ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue d recall (Z-0712-2018)Atrium Medical Corporation2018-02-23
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 recall (Z-2761-2017)Atrium Medical Corporation2017-07-07
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236 recall (Z-2346-2015)Atrium Medical Corporation2015-08-05
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000 recall (Z-1935-2015)Atrium Medical Corporation2015-06-29
Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100 recall (Z-1936-2015)Atrium Medical Corporation2015-06-29
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100 recall (Z-1937-2015)Atrium Medical Corporation2015-06-29
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N recall (Z-1938-2015)Atrium Medical Corporation2015-06-29
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotra recall (Z-1959-2014)Atrium Medical Corporation2014-07-01
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopc recall (Z-0735-2014)Atrium Medical Corporation2014-01-14
Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line co recall (Z-0736-2014)Atrium Medical Corporation2014-01-14
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopc recall (Z-0737-2014)Atrium Medical Corporation2014-01-14
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patie recall (Z-0738-2014)Atrium Medical Corporation2014-01-14
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patie recall (Z-0739-2014)Atrium Medical Corporation2014-01-14
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drai recall (Z-0740-2014)Atrium Medical Corporation2014-01-14
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drai recall (Z-0741-2014)Atrium Medical Corporation2014-01-14
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product C recall (Z-0742-2014)Atrium Medical Corporation2014-01-14
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefi recall (Z-0743-2014)Atrium Medical Corporation2014-01-14
Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, recall (Z-2304-2013)Atrium Medical Corporation2013-09-30
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Every clearance here is in the API, with alerts when new ones post.