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calendar

14 catalysts · 13 device 510k · 1 approval

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no tagged catalysts yet

Week of Feb 24, 2025

14
›Feb 27, 2025approval550d ago
PADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

full page →enfortumab vedotin →fda approvals ↗
›Feb 27, 2025device 510k550d agoNanofiber Solutions, LLC — Rotium (510k cleared)

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

full page →fda device 510k ↗
›Feb 27, 2025device 510k550d agoVeol Medical Technologies Pvt , Ltd. — EzVu Visual Vasopressor injector (EV-19) (510k cleared)KESTRA MEDICAL TECHNOLOGIES, LTD.

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

full page →fda device 510k ↗
›Feb 27, 2025device 510k550d agoXod, Inc. — XOD Diathermia Radiofrequency Device (510k cleared)Xos, Inc.

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

full page →fda device 510k ↗
›Feb 27, 2025device 510k550d agoGleamer Sas — ChestView US (510k cleared)

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

full page →fda device 510k ↗
›Feb 27, 2025device 510k550d agoVascutek, Ltd. — Gelweave™ Vascular Prostheses (510k cleared)

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

full page →fda device 510k ↗
›Feb 27, 2025device 510k550d agoIline Microsystems, S.L. — microINR System (510k cleared)

Product code: GJS. Advisory committee: Hematology. Type: Traditional

full page →fda device 510k ↗
›Feb 27, 2025device 510k550d agoIcotec AG — VADER® Pedicle System and VADER®one Pedicle System (510k cleared)

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

full page →fda device 510k ↗
›Feb 27, 2025device 510k550d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (510k cleared)Hangzhou DAC Biotech Co Ltd

Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

full page →fda device 510k ↗
›Feb 27, 2025device 510k550d agoXaga Surgical — Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (510k cleared)

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

full page →fda device 510k ↗
›Feb 27, 2025device 510k550d agoBecton Dickinson Infusion Therapy Systems, Inc. — PIVO™ Pro Needle-free Blood Collection Device (510k cleared)

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

full page →fda device 510k ↗
›Feb 27, 2025device 510k550d agoThermo Fisher Scientific — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

full page →fda device 510k ↗
›Feb 27, 2025device 510k550d agoL&K BIOMED Co., Ltd. — CastleLoc Pectus Bar System (510k cleared)NeuCen BioMed Co Ltd

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

full page →fda device 510k ↗
›Feb 27, 2025device 510k550d agoBrosmed Medical Co., Ltd. — Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter (510k cleared)

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

full page →fda device 510k ↗
$TMO447.81+1.31%
$XOSWW
$KMTS20.35+8.13%