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8,792 catalysts · 3,189 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 584 earnings
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8,792 catalysts · 3,189 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 584 earnings
Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536; — Reason: A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes. — Status: Ongoing
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 — Reason: Surgical light assembly may not adequate support the weight of the ceiling cover. — Status: Ongoing
GM grant. $84,940. PI: June-Yung Kim
AI grant. $862,748. PI: Ype Peter De Jong
AI grant. $437,250. PI: Emrullah Korkmaz
AI grant. $417,295. PI: Kevin S. McIver
AI grant. $243,600. PI: Ekaterina Heldwein
AI grant. $416,622. PI: Alban Longchamp
AT grant. $29,965. PI: Marcy J Balunas
NS grant. $250,000. PI: Thomas G Bifano
AI grant. $632,994. PI: Jeanne Ann Hardy
DC grant. $687,094. PI: Ulrich Mueller
Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION
Sponsor: COSETTE. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ORGANON USA LLC. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL
Sponsor: BIOCON PHARMA. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL
Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL
Sponsor: FOURRTS LABS. Form: CAPSULE. Route: ORAL
Sponsor: FOUGERA PHARMS. Form: OINTMENT. Route: TOPICAL
Sponsor: FOUGERA PHARMS. Form: OINTMENT. Route: TOPICAL
Sponsor: FOUGERA PHARMS. Form: OINTMENT. Route: TOPICAL
Sponsor: IPCA LABS LTD. Form: TABLET. Route: ORAL
Sponsor: ORBICULAR. Form: SOLUTION. Route: SUBCUTANEOUS
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: IYO. Advisory committee: Radiology. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MAI. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: QJF. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JOW. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30
Supplement type: Real-Time Process. Product code: EZW. Advisory committee: GU. Decision: APPR
Supplement type: Real-Time Process. Product code: QON. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: MPW. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NEK. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPZ. Advisory committee: DE. Decision: OK30
Supplement type: 30-Day Notice. Product code: SGV. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30