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30 catalysts · 20 device 510k · 10 approval
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30 catalysts · 20 device 510k · 10 approval
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)
Sponsor: LONG GROVE PHARMS. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL
Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION
Sponsor: BAXTER HLTHCARE CORP. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION
Product code: MOL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: SAH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: POL. Advisory committee: Neurology. Type: Special
Product code: PSY. Advisory committee: Pathology. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: KDI. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PCH. Advisory committee: Microbiology. Type: Special
Product code: BZQ. Advisory committee: Anesthesiology. Type: Traditional
Product code: EFB. Advisory committee: Dental. Type: Traditional
Product code: PHR. Advisory committee: Dental. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: MOS. Advisory committee: Radiology. Type: Traditional
Product code: OZN. Advisory committee: Microbiology. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional