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Maquet Cardiovascular, LLC

239 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Maquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01 recall (Z-1664-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01 recall (Z-1665-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01 recall (Z-1666-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2) material: 70 recall (Z-1667-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02 recall (Z-1668-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material: 70 recall (Z-1669-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01 recall (Z-1670-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01 recall (Z-1671-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01 recall (Z-1672-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01 recall (Z-1673-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal Material: 709000069R02 recall (Z-1674-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01 recall (Z-1675-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01 recall (Z-1676-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01 recall (Z-1677-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-T 52301 Sash & Accessory Pack Material:-709000266R01 recall (Z-1678-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01 recall (Z-1679-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01 recall (Z-1680-2019)Maquet Cardiovascular, LLC2019-05-31
Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axiu recall (Z-0132-2015)Maquet Cardiovascular, LLC2014-10-24
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour recall (Z-0466-2014)Maquet Cardiovascular, LLC2013-12-06
Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance recall (Z-0001-2014)Maquet Cardiovascular, LLC2013-10-01
MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Us recall (Z-1149-2013)Maquet Cardiovascular, LLC2013-04-18
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and defla recall (Z-0662-2013)Maquet Cardiovascular, LLC2013-01-09
ACROBAT Stabilizers- ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum Off- recall (Z-0967-2012)Maquet Cardiovascular, LLC2012-02-06
XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners. Product Usage recall (Z-0968-2012)Maquet Cardiovascular, LLC2012-02-06
VASOVIEW 6 Endoscopic Vessel Harvesting System Manufactured by Maquet Cardiovascular, LLC; recall (Z-3270-2011)Maquet Cardiovascular, LLC2011-09-20
VASOVIEW 7xB Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascular, L recall (Z-3271-2011)Maquet Cardiovascular, LLC2011-09-20
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascula recall (Z-3272-2011)Maquet Cardiovascular, LLC2011-09-20
Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the pro recall (Z-1666-2011)Maquet Cardiovascular, LLC2011-03-16
Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascu recall (Z-1593-2011)Maquet Cardiovascular, LLC2011-03-07
Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular recall (Z-0940-2011)Maquet Cardiovascular, LLC2011-02-01
Hemashield Gold Woven Double Velour Vascular Branch Graft recall (Z-2061-2010)Maquet Cardiovascular, LLC2010-07-22
Hemashield Double Velour Cardiovascular Fabrics. recall (Z-2062-2010)Maquet Cardiovascular, LLC2010-07-22
Hemashield Platinum Woven and Knitted Double Velour Vascular Grafts. recall (Z-2063-2010)Maquet Cardiovascular, LLC2010-07-22
Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch. recall (Z-2064-2010)Maquet Cardiovascular, LLC2010-07-22
Hemashield Platinum Woven Double Velour TAAA Vascular Grafts. recall (Z-2065-2010)Maquet Cardiovascular, LLC2010-07-22
Hemashield Gold Woven and Knitted Double Vascular Grafts. recall (Z-2066-2010)Maquet Cardiovascular, LLC2010-07-22
EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intende recall (Z-1606-2010)Maquet Cardiovascular, LLC2010-05-14
EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intended us recall (Z-1607-2010)Maquet Cardiovascular, LLC2010-05-14
EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovas recall (Z-0866-2010)Maquet Cardiovascular, LLC2010-02-26
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Every clearance here is in the API, with alerts when new ones post.