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132 catalysts · 80 grant · 21 device recall · 19 device pma · 12 device 510k
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132 catalysts · 80 grant · 21 device recall · 19 device pma · 12 device 510k
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component — Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. — Status: Ongoing
Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE, FREDX5522-PMA, FREDX3522-PMA, FREDX4525-PMA, FREDX5015-PMA, FREDX5532-PMA, FREDX4013-PMA, FREDX3513-PMA, FREDX4515-PMA, FREDX3517-PMA, MV-F352427X — Reason: Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences. — Status: Ongoing
AT grant. $306,872. PI: Chase Madison Clark
HL grant. $320,838. PI: WILLIAM A SMITH
AR grant. $366,639. PI: Christina Charles-Schoeman
AR grant. $646,506. PI: Zhiliang Cheng
HD grant. $787,154. PI: Sabra L. Katz-Wise
HD grant. $236,547. PI: Hui-Ju Young
HL grant. $647,573. PI: James Even Voss
CA grant. $425,304. PI: Hao Zhu
NR grant. $52,538. PI: Lauren Anne Fisher
GM grant. $501,000. PI: James M Holton
HL grant. $524,179. PI: Nathan Richard Blue
DK grant. $843,485. PI: James Franklin Wharam
HL grant. $174,389. PI: Nupoor Narula
HL grant. $134,537. PI: Giles Blaney
DK grant. $49,538. PI: Gabriella Robilotto
AA grant. $337,500. PI: Rajani Maiya
AG grant. $480,710. PI: SHANTHINI SOCKANATHAN
AI grant. $240,000. PI: Kelly Erin Riordan Bachta
GM grant. $155,695. PI: Jessica Pullan
HL grant. $694,466. PI: HARPREET SINGH
HL grant. $644,180. PI: CHRISTOPHER S CHEN
HL grant. $1,074,576. PI: GUOSHUN WANG
HL grant. $571,021. PI: Gerald Samuel Bloomfield
HL grant. $689,928. PI: John F Eberth
DK grant. $243,750. PI: Parker C. Wilson
AG grant. $327,000. PI: Huitong Ding
CA grant. $148,500. PI: Ikjot Singh Sohal
HL grant. $733,439. PI: Dogukan Mizrak
CA grant. $411,152. PI: Jen-Tsan Ashley Chi
AG grant. $398,046. PI: Margaret Windy McNerney
HD grant. $793,462. PI: Elizabeth Anne BUKUSI
DK grant. $731,850. PI: Joseph Bass
DK grant. $2,249,376. PI: Brian T Fife
DK grant. $773,112. PI: ROBERT G ROEDER
HL grant. $654,388. PI: ANDREW Robert MARKS
GM grant. $631,989. PI: Thomas Neil Snaddon
AR grant. $115,301. PI: Joe Kodama
HL grant. $129,600. PI: Cheng-I Jonathan Ma
AA grant. $144,084. PI: Nagalakshmi Balasubramanian
HL grant. $516,986. PI: Paula M Cannon
HL grant. $1,017,232. PI: Biree Andemariam
AI grant. $464,615. PI: Cynthia Esetban
HD grant. $293,550. PI: Whitney Elizabeth Harrington
HL grant. $841,555. PI: Marie-France Hivert
CA grant. $150,804. PI: Yan Guo
CA grant. $506,498
CA grant. $2,532,970. PI: lynn briscoe
HL grant. $245,624. PI: Matthew R Lammi