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11 catalysts · 6 device 510k · 2 approval · 1 device pma · 1 device recall · 1 grant
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11 catalysts · 6 device 510k · 2 approval · 1 device pma · 1 device recall · 1 grant
Sponsor: VANDA PHARMS INC. Form: CAPSULE. Route: ORAL
Sponsor: SAGENT. Form: SOLUTION. Route: INTRAVENOUS
Product code: CHH. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Traditional
Product code: QCH. Advisory committee: Microbiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: FLE. Advisory committee: General Hospital. Type: Traditional
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 — Reason: Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality. — Status: Ongoing
MH grant. $181,224. PI: ALISA MO