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22,484 catalysts · 4,728 grant · 4,226 device 510k · 3,706 8k filing · 3,156 approval · 2,000 device pma · 2,000 device recall
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22,484 catalysts · 4,728 grant · 4,226 device 510k · 3,706 8k filing · 3,156 approval · 2,000 device pma · 2,000 device recall
HL grant. $43,560. PI: Stephanie Armbruster
EB grant. $597,977. PI: Zheng Yan
GM grant. $105,987. PI: Janet Iwasa
GM grant. $225,000. PI: Jacob T Mey
Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: HETERO LABS LTD III. Form: SYRUP. Route: ORAL
Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION
Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: BIOCON LTD. Form: CAPSULE. Route: ORAL
Sponsor: BIOCON LTD. Form: CAPSULE. Route: ORAL
Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: GILEAD SCIENCES INC. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: CAPSULE. Route: ORAL
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: KRA. Advisory committee: Cardiovascular. Type: Traditional
Product code: GXY. Advisory committee: Neurology. Type: Special
Product code: KTI. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: EHD. Advisory committee: Dental. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Abbreviated
Product code: QZF. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QKA. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FWP. Advisory committee: General, Plastic Surgery. Type: Special
Product code: SFP. Advisory committee: Anesthesiology. Type: Traditional
Product code: DTR. Advisory committee: Cardiovascular. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: DTZ. Advisory committee: Cardiovascular. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: OMP. Advisory committee: General, Plastic Surgery. Type: Traditional
Advisory committee: Unknown. Type: Traditional
Product code: QFG. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: DQD. Advisory committee: Cardiovascular. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: Real-Time Process. Product code: MAQ. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NUU. Advisory committee: OP. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: PJY. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: AN. Decision: OK30
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor — Reason: Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring. — Status: Ongoing