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8,729 catalysts · 3,126 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 584 earnings
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8,729 catalysts · 3,126 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 584 earnings
DK grant. $717,457. PI: Yunmeng Liu
DK grant. $123,375. PI: Dominique Bailey
DA grant. $699,748. PI: STEPHEN R DAGER
AG grant. $1,293,752. PI: Jianing Li
DA grant. $185,571. PI: James Travis Donahoe
AG grant. $347,657. PI: Darshan Sapkota
DA grant. $32,847. PI: JAMES Christopher ANTHONY
HL grant. $1,097,760. PI: Harold A Chapman
AG grant. $529,744. PI: Jae-eun Kang Miller
AG grant. $668,290. PI: Jessica M Ellis
DK grant. $176,671. PI: Vikram Kalathur Raghu
DE grant. $679,631. PI: CHARLES SFEIR
GM grant. $395,698. PI: Daniel McIntyre
DK grant. $113,089. PI: Heather A McCauley
AG grant. $49,620. PI: Orly Lazarov
AG grant. $681,908. PI: RON R KOPITO
GM grant. $456,500. PI: Bingfei Yu
GM grant. $484,000. PI: YASUHIRO ARIMURA
AG grant. $790,288. PI: Michael Ryan Corces
AG grant. $560,180. PI: Jaquelyn Lorraine Jahn
AG grant. $424,371. PI: Natalie Celia Tronson
DE grant. $341,000. PI: Hae Ryong Kwon
AG grant. $657,222. PI: Todd E Golde
AG grant. $303,163. PI: ULRICH E MAYR
AG grant. $1,256,627. PI: William S Bush
AG grant. $382,830. PI: Kirby P Mayer
AG grant. $722,746. PI: Alexander Mattia Presciutti
NS grant. $122,850. PI: Yuliya Voskobiynyk
DA grant. $107,090. PI: Brooke H Kohn
AG grant. $324,000. PI: Xiaomo Xiong
DA grant. $346,500. PI: Megan Reed
DA grant. $736,713. PI: Ryan Cook
AG grant. $620,441. PI: David M Acton
AG grant. $453,750. PI: Peng Li
AG grant. $3,174,899. PI: Ksenia V. Kastanenka
DA grant. $2,352,000. PI: Schahram Akbarian
DC grant. $136,911. PI: Aaron C Moberly
DE grant. $408,951. PI: Fernando P.S. Guastaldi
DA grant. $672,701. PI: McKenna Claire Eastment
DA grant. $648,389. PI: Michael J Beckstead
AG grant. $701,073. PI: Susan Cheng
AG grant. $591,089. PI: Jeah Jung
AG grant. $53,461. PI: MITCHELL S SOMMERS
THORACIC ROBOTS, DYNJ908777B — Reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure. — Status: Ongoing
Airway Exam Kit, DYKE1796 — Reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure. — Status: Ongoing
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. — Reason: Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps. — Status: Ongoing
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A — Reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure. — Status: Ongoing
Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PACK, DYNJ38313B 4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I 5. KIT, WR THORACIC, DYNJ911252 6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B 7. LEX THORACIC, DYNJ902016K DYNJ902016L 8. ORGAN PROCUREMENT, DYNJ908686 9. PULMONARY PACK, DYKE1859 10. THORACIC, DYNJ901666L 11. THORACIC ROBOTICS, DYNJ908777A 12. THORACOTOMY/THORACOSCOPY, DYNJ900482N DYNJ900482O 13. XPS, DYNJ907605 — Reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure. — Status: Ongoing
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm — Reason: Drainable large pouch may leak due to manufacturing issue. — Status: Ongoing
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm — Reason: Drainable large pouch may leak due to manufacturing issue. — Status: Ongoing