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20,396 catalysts · 4,728 grant · 3,277 8k filing · 3,149 device 510k · 2,804 approval · 2,000 device pma · 2,000 device recall
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20,396 catalysts · 4,728 grant · 3,277 8k filing · 3,149 device 510k · 2,804 approval · 2,000 device pma · 2,000 device recall
Sponsor: NOVIMMUNE S.A.. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PLS. Advisory committee: PA. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: NXW. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: SBL. Advisory committee: PA. Decision: OK30
Supplement type: Real-Time Process. Product code: QMG. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Advisory committee: PA. Decision: OK30
Supplement type: Real-Time Process. Product code: PQP. Advisory committee: PA. Decision: APPR
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: DZL. Advisory committee: Dental. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Special
Product code: QZB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IZI. Advisory committee: Radiology. Type: Traditional
Product code: DWF. Advisory committee: Cardiovascular. Type: Special
Product code: DRF. Advisory committee: Cardiovascular. Type: Traditional
Product code: FAS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OBP. Advisory committee: Neurology. Type: Special
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EIA. Advisory committee: Dental. Type: Traditional
Product code: JOY. Advisory committee: Hematology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Special
Product code: OAS. Advisory committee: Radiology. Type: Special
Product code: LHN. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ELW. Advisory committee: Dental. Type: Abbreviated
Product code: BZQ. Advisory committee: Anesthesiology. Type: Traditional
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: BSP. Advisory committee: Anesthesiology. Type: Traditional
Product code: OMP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OVE. Advisory committee: Orthopedic. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PMX. Advisory committee: SU. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: LNR. Advisory committee: GU. Decision: OK30
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: CAF. Advisory committee: Anesthesiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Abbreviated
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional