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calendar

11 catalysts · 9 device 510k · 2 approval

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Week of Sep 30, 2024

11
›Sep 30, 2024approval701d ago
DAYBUE (TROFINETIDE) — FDA approvaltrofinetide

Sponsor: ACADIA PHARMS INC. Form: SOLUTION. Route: ORAL

full page →trofinetide →fda approvals ↗
›Sep 30, 2024approval701d agoDAYBUE (TROFINETIDE) — FDA approvaltrofinetide

Sponsor: ACADIA PHARMS INC. Form: SOLUTION. Route: ORAL

full page →trofinetide →fda approvals ↗
›Sep 30, 2024device 510k701d agoKem Medical Products Corporation — Kem Medical Lead-free Chemical Indicators for Steam Sterilization (510k cleared)

Product code: JOJ. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗
›Sep 30, 2024device 510k701d agoDentalmax Co., Ltd. — LUXEN 5G (510k cleared)

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

full page →fda device 510k ↗
›Sep 30, 2024device 510k701d agoMikron Makina Sanayi VE Ticaret Ltd. Sti. — MSFX MIKRON SPINAL FIXATION SYSTEM (510k cleared)

Product code: NKB. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Sep 30, 2024device 510k701d agoRecensmedical, Inc. — OcuCool (510k cleared)

Product code: QZQ. Advisory committee: Unknown. Type: Direct

full page →fda device 510k ↗
›Sep 30, 2024device 510k701d agoYsi, Inc. — YSI 2900C Biochemistry Analyzer (510k cleared)

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

full page →fda device 510k ↗
›Sep 30, 2024device 510k701d agoGuangzhou Wondfo Biotech Co., Ltd. — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (510k cleared)

Product code: QYT. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗
›Sep 30, 2024device 510k701d agoMicroPort NeuroTech (Shanghai) Co., Ltd. — Numen™ Coil Embolization System; NumenFR™ Detachment System (510k cleared)

Product code: HCG. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗
›Sep 30, 2024device 510k701d agoProcept Biorobotics — AQUABEAM Robotic System (AB2000) (510k cleared)PROCEPT BioRobotics Corp

Product code: PZP. Advisory committee: General, Plastic Surgery. Type: Special

full page →fda device 510k ↗
›Sep 30, 2024device 510k701d agoVantis Vascular, Inc. — CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) (510k cleared)

Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗
$ACAD29.11-2.09%
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