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23,400 catalysts · 4,728 grant · 4,710 device 510k · 3,684 8k filing · 3,487 approval · 2,000 device pma · 2,000 device recall
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23,400 catalysts · 4,728 grant · 4,710 device 510k · 3,684 8k filing · 3,487 approval · 2,000 device pma · 2,000 device recall
Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not applicable — Reason: Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance. — Status: Ongoing
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table — Reason: The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion. — Status: Ongoing
AA grant. $39,309. PI: Hanna Marie Hebden
Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION
Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA. Form: TABLET. Route: ORAL
Sponsor: HIKMA. Form: TABLET. Route: ORAL
Sponsor: TORRENT. Form: CAPSULE. Route: ORAL
Sponsor: DR REDDYS LABS SA. Form: TABLET. Route: ORAL-28
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: UNITED THERAP. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS
Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS
Sponsor: METHODIST. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: ABBVIE. Form: SOLUTION. Route: ORAL
Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL
Sponsor: ACER. Form: FOR SUSPENSION. Route: ORAL
Sponsor: RUBICON. Form: CONCENTRATE. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: UMEDICA. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: GMQ. Advisory committee: Microbiology. Type: Traditional
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: QXQ. Advisory committee: General Hospital. Type: Traditional
Product code: NBW. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: SGE. Advisory committee: Neurology. Type: Special
Product code: PZP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: PLV. Advisory committee: Dental. Type: Traditional
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OAE. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LMH. Advisory committee: SU. Decision: APPR