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29 catalysts · 24 device 510k · 3 device pma · 2 approval
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29 catalysts · 24 device 510k · 3 device pma · 2 approval
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