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77 catalysts · 28 device pma · 22 grant · 11 approval · 11 device 510k · 5 device recall · 1 earnings
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77 catalysts · 28 device pma · 22 grant · 11 approval · 11 device 510k · 5 device recall · 1 earnings
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System — Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) — Status: Ongoing
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System — Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) — Status: Ongoing
Artegraft Vascular Graft; REF#: AG740; — Reason: Labeling mix-up resulting in the incorrect lot outer packaging of product. — Status: Ongoing
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; — Reason: Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit. — Status: Ongoing
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2" — Reason: Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result. — Status: Ongoing
GM grant. $224,737. PI: Elisabetta Liverani
NS grant. $110,118. PI: RODNEY P GUTTMANN
AI grant. $16,500. PI: TERRY L. SHEPPARD
AI grant. $457,875. PI: MELISSA J CAIMANO
AI grant. $596,318. PI: Neal Mathew Alto
AI grant. $649,484. PI: VLADIMIR P BADOVINAC
DK grant. $117,000. PI: VERA FRIDMAN
AI grant. $190,825. PI: Jessica Lin
GM grant. $142,182. PI: Kushal Seetharam
AI grant. $790,946. PI: Nathan Schmidt
AI grant. $435,875. PI: Vincent Tam
AI grant. $790,847. PI: Zandrea Ambrose
AI grant. $235,500. PI: Paul D Gershon
AI grant. $490,704. PI: Amanda Martinot
AI grant. $444,125. PI: Judith A Woodfolk
AI grant. $515,625. PI: Dmitry Lyumkis
GM grant. $462,500. PI: Yuuta Imoto
AI grant. $460,625. PI: YONG-RUI ZOU
AI grant. $729,189. PI: Adam Lee Bailey
AI grant. $195,750. PI: Liudi Tang
AI grant. $440,000. PI: SATISH N NADIG
GM grant. $160,566. PI: Mohammad Razavi Rizi