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23 catalysts · 19 device 510k · 4 approval
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23 catalysts · 19 device 510k · 4 approval
Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL
Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: CHECKPOINT THERAPEUTICS INC. Form: INJECTABLE. Route: INJECTION
Product code: CHL. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: MNS. Advisory committee: Anesthesiology. Type: Traditional
Product code: MNT. Advisory committee: Anesthesiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Special
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Product code: FER. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ETN. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: MWJ. Advisory committee: Cardiovascular. Type: Traditional
Product code: GXY. Advisory committee: Neurology. Type: Traditional
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: OBO. Advisory committee: Ophthalmic. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OVD. Advisory committee: Orthopedic. Type: Special
Product code: JAF. Advisory committee: Radiology. Type: Traditional