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calendar

15 catalysts · 14 device 510k · 1 approval

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no tagged catalysts yet

Week of Dec 30, 2024

15
›Jan 3, 2025approval605d ago
PYRUKYND (MITAPIVAT SULFATE) — FDA approvalAGIOS PHARMACEUTICALS, INC.

Sponsor: AGIOS PHARMS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jan 3, 2025device 510k605d agoPentax of America, Inc. — PENTAX Medical Video Colonoscope (EC38-i20cWL) (510k cleared)

Product code: FDF. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗
›Jan 3, 2025device 510k605d agoInbella Medical, Inc. — Inbella RF System (510k cleared)

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
›Jan 3, 2025device 510k605d agoEunsung Global Corp — DUET-V (Model: ESK-3261DV) (510k cleared)

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
›Jan 3, 2025device 510k605d agoProimtech Saglik Urunleri Anonim Sirketi — GBR System (510k cleared)

Product code: DZL. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗
›Jan 3, 2025device 510k605d agoDk Medical System — INNOVISION-EXII (510k cleared)

Product code: KPR. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Jan 3, 2025device 510k605d agoSiemens Medical Solutions USA, Inc. — syngo.CT Dual Energy (510k cleared)

Product code: JAK. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Jan 3, 2025device 510k605d agoAbbott Point of Care, Inc. — i-STAT hs-TnI cartridge with the i-STAT 1 System (510k cleared)

Product code: MMI. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗
›Jan 3, 2025device 510k605d agoInventis S.R.L. — Synapsys VHIT (510k cleared)

Product code: GWN. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗
›Jan 3, 2025device 510k605d agoMallinckrodt Manufacturing, LLC — EVOLVE Nitric Oxide Delivery System (510k cleared)Mallinckrodt LLC

Product code: MRN. Advisory committee: Anesthesiology. Type: Special

full page →fda device 510k ↗
›Jan 3, 2025device 510k605d agoNobel Biocare AB — NobelProcera Zirconia Implant Bridge (510k cleared)

Product code: NHA. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗
›Jan 3, 2025device 510k605d agoZinkh NV — Elemental Granulate (510k cleared)

Product code: OLR. Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗
›Jan 3, 2025device 510k605d agoOrmco Corporation — Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive (510k cleared)

Product code: DYH. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗
›Jan 3, 2025device 510k605d agoGe Medical Systems Israel, Functional Imaging — Clarify DL (510k cleared)

Product code: LLZ. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Jan 3, 2025device 510k605d agoJLK, Inc. — JLK-ICH (510k cleared)

Product code: QAS. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
$AGIO33.32-2.80%