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calendar

18 catalysts · 13 device 510k · 5 approval

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no tagged catalysts yet

Week of Feb 10, 2025

18
›Feb 11, 2025approval566d ago
CAMCEVI KIT (LEUPROLIDE MESYLATE) — FDA approvalForesee Pharmaceuticals Co Ltd

Sponsor: ACCORD. Form: EMULSION. Route: SUBCUTANEOUS

full page →fda approvals ↗
›Feb 11, 2025approval566d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL

full page →EVRYSDI →fda approvals ↗
›Feb 11, 2025approval566d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL

full page →EVRYSDI →fda approvals ↗
›Feb 11, 2025approval566d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: RHODES PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Feb 11, 2025approval566d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗
›Feb 11, 2025device 510k566d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Vivid iq (510k cleared)

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

full page →fda device 510k ↗
›Feb 11, 2025device 510k566d agoInfinitum Eta, Ltd. — NUVENTUS NV.C™ Surgical Cassette and Tray (510k cleared)

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

full page →fda device 510k ↗
›Feb 11, 2025device 510k566d agoInbella Medical, Inc. — InbellaBody System (510k cleared)

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

full page →fda device 510k ↗
›Feb 11, 2025device 510k566d agoNoris Medical , Ltd. — LONGY Implant and LONGY-N Implant (510k cleared)

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

full page →fda device 510k ↗
›Feb 11, 2025device 510k566d agoRoche Molecular Systems, Inc. — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems (510k cleared)

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

full page →fda device 510k ↗
›Feb 11, 2025device 510k566d agoGuangdong Xinyu Electronic and Technology Co., Ltd. — Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) (510k cleared)

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

full page →fda device 510k ↗
›Feb 11, 2025device 510k566d agoSignus Medizintechnik GmbH — CYLOX® ST (510k cleared)

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

full page →fda device 510k ↗
›Feb 11, 2025device 510k566d agoTeleflex Incorporated — Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) (510k cleared)TELEFLEX INC

Product code: BTR. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗
›Feb 11, 2025device 510k566d agoAbbott Diagnostics Scarborough, Inc. — BinaxNOW™ COVID-19 Antigen Self Test (510k cleared)

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

full page →fda device 510k ↗
›Feb 11, 2025device 510k566d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Vivid T9/Vivid T8 (510k cleared)

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

full page →fda device 510k ↗
›Feb 11, 2025device 510k566d agoMorari, Inc. — MOR (510k cleared)

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

full page →fda device 510k ↗
›Feb 11, 2025device 510k566d agoDongguan Zsr Biomedical Technology Company Limited — Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) (510k cleared)

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

full page →fda device 510k ↗
›Feb 11, 2025device 510k566d agoShoulder Innovations, Inc. — InSet Total Shoulder System (510k cleared)SHOULDER INNOVATIONS, INC.

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

full page →fda device 510k ↗
$IGC0.2670+0.41%
$KVUE19.17-0.16%
$SI
$TFX127.00+1.63%