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23,690 catalysts · 4,944 device 510k · 4,728 grant · 3,685 8k filing · 3,542 approval · 2,000 device pma · 2,000 device recall
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23,690 catalysts · 4,944 device 510k · 4,728 grant · 3,685 8k filing · 3,542 approval · 2,000 device pma · 2,000 device recall
Sponsor: UNITED THERAP. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS
Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS
Sponsor: METHODIST. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: ABBVIE. Form: SOLUTION. Route: ORAL
Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL
Sponsor: ACER. Form: FOR SUSPENSION. Route: ORAL
Sponsor: RUBICON. Form: CONCENTRATE. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: UMEDICA. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: GMQ. Advisory committee: Microbiology. Type: Traditional
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: QXQ. Advisory committee: General Hospital. Type: Traditional
Product code: NBW. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: SGE. Advisory committee: Neurology. Type: Special
Product code: PZP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: PLV. Advisory committee: Dental. Type: Traditional
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OAE. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LMH. Advisory committee: SU. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: NPT. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: MIH. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MYL. Advisory committee: MI. Decision: APPR
Supplement type: Panel Track. Product code: MJO. Advisory committee: OR. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: NCD. Advisory committee: MI. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing