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calendar

15 catalysts · 13 device 510k · 2 approval

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no tagged catalysts yet

Week of Mar 24, 2025

15
›Mar 24, 2025approval525d ago
SPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

full page →fda approvals ↗
›Mar 24, 2025approval525d agoORLYNVAH (PROBENECID) — FDA approvalLannett Co Inc

Sponsor: ITERUM THERAP. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Mar 24, 2025device 510k525d agoLuma Vision Limited — VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (510k cleared)

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

full page →fda device 510k ↗
›Mar 24, 2025device 510k525d agoAbbott Molecular, Inc. — Alinity m BKV (510k cleared)

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

full page →fda device 510k ↗
›Mar 24, 2025device 510k525d agoXplr , Ltd. — LMNT O2 (510k cleared)

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

full page →fda device 510k ↗
›Mar 24, 2025device 510k525d agoAurora Spine — AERO MIS Facet Fusion System (510k cleared)

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

full page →fda device 510k ↗
›Mar 24, 2025device 510k525d agoStryker Instruments — Sonopet iQ Ultrasonic Aspirator System (5500-050-000) (510k cleared)

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

full page →fda device 510k ↗
›Mar 24, 2025device 510k525d agoBright Uro, Inc. — Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) (510k cleared)

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

full page →fda device 510k ↗
›Mar 24, 2025device 510k525d agoRestor3D, Inc. — TIDAL Fusion Cage System (510k cleared)

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

full page →fda device 510k ↗
›Mar 24, 2025device 510k525d agoControl Medical Technology, Inc. / Dba Ventiv Scientific — VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) (510k cleared)

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

full page →fda device 510k ↗
›Mar 24, 2025device 510k525d agoInnovasis, Inc. — Innovasis Navigation Instruments (510k cleared)

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

full page →fda device 510k ↗
›Mar 24, 2025device 510k525d agoInnovasis — AxTiHA® Stand-Alone ALIF System (510k cleared)

Product code: OVD. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗
›Mar 24, 2025device 510k525d agoPAJUNK GmbH Medizintechnologie — SonoTAP and SonoTAP II (510k cleared)

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

full page →fda device 510k ↗
›Mar 24, 2025device 510k525d agoTotal Joint Othopedics, Inc. — Klassic Knee System - Revision Tibial Baseplate (510k cleared)

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

full page →fda device 510k ↗
›Mar 24, 2025device 510k525d agoBard Peripheral Vascular, Inc. — UltraCor™ Twirl™ Breast Tissue Marker (510k cleared)

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

full page →fda device 510k ↗