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13,494 catalysts · 3,355 8k filing · 2,401 grant · 2,136 approval · 1,479 device 510k · 1,105 device recall · 1,000 device adverse event
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13,494 catalysts · 3,355 8k filing · 2,401 grant · 2,136 approval · 1,479 device 510k · 1,105 device recall · 1,000 device adverse event
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
Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL
Sponsor: PH HEALTH. Form: TABLET. Route: ORAL
Sponsor: ACTELION. Form: TABLET. Route: ORAL
Sponsor: NATCO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION
Sponsor: B BRAUN. Form: INJECTABLE. Route: INJECTION
Sponsor: CADILA PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION
Sponsor: B BRAUN. Form: INJECTABLE. Route: INJECTION
Sponsor: BAUSCH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: NALPROPION. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: NALPROPION. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: LAURUS. Form: TABLET. Route: ORAL
Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION
Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: GLAXOSMITHKLINE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: RISING. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ASCENT PHARMS INC. Form: SOLUTION. Route: ORAL
Sponsor: INTRA-CELLULAR. Form: CAPSULE. Route: ORAL
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: AXSOME. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: TWI PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: UMEDICA. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: JUBILANT GENERICS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: BAUSCH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: AUROBINDO PHARMA USA. Form: TABLET. Route: ORAL