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calendar

16 catalysts · 14 device 510k · 2 approval

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no tagged catalysts yet

Week of Mar 17, 2025

16
›Mar 20, 2025approval529d ago
BYLVAY (ODEVIXIBAT) — FDA approvalodevixibat

Sponsor: IPSEN. Form: CAPSULE. Route: ORAL

full page →odevixibat →fda approvals ↗
›Mar 20, 2025approval529d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →guselkumab →fda approvals ↗
›Mar 20, 2025device 510k529d agoHangzhou AGS MedTech Co., Ltd. — Endoscopic Water Pump (510k cleared)

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

full page →fda device 510k ↗
›Mar 20, 2025device 510k529d agoHunan Haipuming Technology Co., Ltd. — HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) (510k cleared)

Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗
›Mar 20, 2025device 510k529d agoBoston Scientific — iSLEEVE Introducer Set (510k cleared)BOSTON SCIENTIFIC CORP

Product code: DYB. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗
›Mar 20, 2025device 510k529d agoCardiovia , Ltd. — ViaOne Epicardial Access System (510k cleared)

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

full page →fda device 510k ↗
›Mar 20, 2025device 510k529d agoDRTECH Corporation — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG (510k cleared)

Product code: MQB. Advisory committee: Radiology. Type: Special

full page →fda device 510k ↗
›Mar 20, 2025device 510k529d agoSpectrawave, Inc. — Starlight Imaging Catheter (510k cleared)

Product code: NQQ. Advisory committee: Radiology. Type: Special

full page →fda device 510k ↗
›Mar 20, 2025device 510k529d agoPixee Medical — Knee+ (510k cleared)

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

full page →fda device 510k ↗
›Mar 20, 2025device 510k529d agoAvatar Medical — brAIn™ Shoulder Positioning (510k cleared)

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

full page →fda device 510k ↗
›Mar 20, 2025device 510k529d agoRiverpoint Medical, LLC — RootMend MRR (510k cleared)

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

full page →fda device 510k ↗
›Mar 20, 2025device 510k529d agoShenzhen TPH Technology Co., Ltd. — Ameda GLO Wearable Breast Pump (Model W8S) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special

full page →fda device 510k ↗
›Mar 20, 2025device 510k529d agoJoylux, Inc. — Joylux Intimacy Gel (PG3100) (510k cleared)

Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional

full page →fda device 510k ↗
›Mar 20, 2025device 510k529d agoMeridian Bioscience, Inc. — Revogene (510k cleared)Meridian Corp

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

full page →fda device 510k ↗
›Mar 20, 2025device 510k529d agoKyocera Medical Technologies, Inc. — Tesera-k PL System and Tesera-k XL System (510k cleared)Medical Care Technologies Inc.

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

full page →fda device 510k ↗
›Mar 20, 2025device 510k529d agoVent Creativity — Vent Creativity Knee v1.0 (Hermes) (510k cleared)

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

full page →fda device 510k ↗
$MDCE0.00020.00%
$FRTRY
$MRBK
$BSX46.84+0.36%