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28 catalysts · 18 device 510k · 8 device pma · 2 approval
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28 catalysts · 18 device 510k · 8 device pma · 2 approval
Sponsor: STERISCIENCE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Supplement type: 30-Day Notice. Product code: QWK. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: MJO. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: PRC. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NQR. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NWX. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NHL. Advisory committee: NE. Decision: APPR
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: DRE. Advisory committee: Cardiovascular. Type: Special
Product code: SEU. Advisory committee: Cardiovascular. Type: Direct
Product code: ONO. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Special
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: PEM. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LJS. Advisory committee: General Hospital. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: LXB. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: ONB. Advisory committee: General Hospital. Type: Special
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: MHX. Advisory committee: Cardiovascular. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Special
Product code: LBI. Advisory committee: General Hospital. Type: Traditional
Product code: OWX. Advisory committee: General, Plastic Surgery. Type: Traditional