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19,539 catalysts · 4,728 grant · 3,086 8k filing · 2,737 device 510k · 2,721 approval · 2,000 device recall · 1,916 device pma
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19,539 catalysts · 4,728 grant · 3,086 8k filing · 2,737 device 510k · 2,721 approval · 2,000 device recall · 1,916 device pma
Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Supplement type: Normal 180 Day Track No User Fee. Product code: ONU. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NZK. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPW. Advisory committee: CV. Decision: OK30
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HAE. Advisory committee: Neurology. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MWI. Advisory committee: Cardiovascular. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Special
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional
Product code: OWY. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FLE. Advisory committee: General Hospital. Type: Traditional
Product code: FCM. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PAM. Advisory committee: Microbiology. Type: Traditional
Product code: FRC. Advisory committee: General Hospital. Type: Special
Product code: FRG. Advisory committee: General Hospital. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: QNM. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: BTA. Advisory committee: General, Plastic Surgery. Type: Special
Product code: PNL. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Supplement type: Normal 180 Day Track. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NSA. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: MG. Decision: OK30
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QOG. Advisory committee: General Hospital. Type: Special
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: ABBVIE. Form: TABLET. Route: ORAL
Sponsor: ABBVIE. Form: TABLET. Route: ORAL
Supplement type: Normal 180 Day Track. Product code: QMG. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LMF. Advisory committee: SU. Decision: APPR
Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30