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12,903 catalysts · 3,350 8k filing · 2,377 grant · 2,035 approval · 1,373 device 510k · 1,000 device adverse event · 929 device pma
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12,903 catalysts · 3,350 8k filing · 2,377 grant · 2,035 approval · 1,373 device 510k · 1,000 device adverse event · 929 device pma
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: FOR SOLUTION. Route: ORAL
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: ORAL
Sponsor: HAINAN POLY PHARM. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL
Product code: SCA. Advisory committee: Microbiology. Type: Dual Track
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: HQC. Advisory committee: Ophthalmic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: FIP. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: SDO. Advisory committee: Physical Medicine. Type: Traditional
Product code: CAF. Advisory committee: Anesthesiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: FRF. Advisory committee: General Hospital. Type: Traditional
Product code: SGN. Advisory committee: Neurology. Type: Direct
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: LSR. Advisory committee: Microbiology. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: Real-Time Process. Product code: OCM. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: MTA. Advisory committee: OP. Decision: APPR
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones. — Reason: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues. — Status: Ongoing
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01. — Reason: Potential for incomplete seal on header bag. — Status: Ongoing
Halyard, EP LAB PK. Catalog Number: ESJH009-03. — Reason: Potential for incomplete seal on header bag. — Status: Ongoing
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543 — Reason: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings. — Status: Ongoing
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01. — Reason: Potential for incomplete seal on header bag. — Status: Ongoing
Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09. — Reason: Potential for incomplete seal on header bag. — Status: Ongoing
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients. — Reason: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. — Status: Ongoing
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002 — Reason: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings. — Status: Ongoing
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones. — Reason: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues. — Status: Ongoing
Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10. — Reason: Potential for incomplete seal on header bag. — Status: Ongoing
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S — Reason: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings. — Status: Ongoing
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones. — Reason: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues. — Status: Ongoing
AR grant. $49,538. PI: Sandra Del Carmen Sandria
GM grant. $75,052. PI: Shivaani Sanjay Gandhi
Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: MARKSANS PHARMA. Form: TABLET. Route: ORAL
Sponsor: BIOCON PHARMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: GLAND PHARMA LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: DORC. Form: SOLUTION. Route: OPHTHALMIC
Sponsor: SANDOZ. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: ADVANZ PHARMA. Form: GEL. Route: TOPICAL