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19,656 catalysts · 4,728 grant · 3,126 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma
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19,656 catalysts · 4,728 grant · 3,126 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: MJO. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: QZK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: EOB. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Abbreviated
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: MSX. Advisory committee: Cardiovascular. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: FDT. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: OWQ. Advisory committee: Cardiovascular. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: GZI. Advisory committee: Neurology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
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