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32 catalysts · 14 approval · 9 device 510k · 7 device pma · 2 device recall
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32 catalysts · 14 approval · 9 device 510k · 7 device pma · 2 device recall
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Sponsor: SHANDONG. Form: LIQUID. Route: INHALATION
Sponsor: RHODES PHARMS. Form: TABLET. Route: ORAL
Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION
Sponsor: EUROFARMA. Form: SUSPENSION. Route: TOPICAL
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: RECORDATI RARE. Form: TABLET. Route: ORAL
Sponsor: MSN. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: AMNEAL PHARMS. Form: SOLUTION. Route: ORAL
Sponsor: EUROFARMA. Form: CREAM. Route: TOPICAL
Sponsor: PHARMACIA AND UPJOHN. Form: INJECTABLE. Route: INJECTION
Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: PBF. Advisory committee: Orthopedic. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: FMF. Advisory committee: General Hospital. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Supplement type: Panel Track. Product code: LMH. Advisory committee: SU. Decision: APPR
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: QON. Advisory committee: GU. Decision: APPR
Supplement type: Real-Time Process. Product code: EZW. Advisory committee: GU. Decision: APPR
Supplement type: Real-Time Process. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LMG. Advisory committee: SU. Decision: APPR
Supplement type: Real-Time Process. Advisory committee: NE. Decision: APPR
Cardiosave Rescue. Intra-Aortic Balloon Pump system. — Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. — Status: Ongoing
Cardiosave Hybrid. Intra-Aortic Balloon Pump system. — Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. — Status: Ongoing