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calendar

17 catalysts · 8 device 510k · 7 device pma · 2 approval

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  • device 510k8
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no tagged catalysts yet

Week of Jun 9, 2025

17
›Jun 10, 2025approval
432d ago
QULIPTA (ATOGEPANT) — FDA approvalatogepant

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →atogepant →fda approvals ↗
›Jun 10, 2025approval432d agoQULIPTA (ATOGEPANT) — FDA approvalatogepant

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →atogepant →fda approvals ↗
›Jun 10, 2025device pma432d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Cathete (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: QMG. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗
›Jun 10, 2025device pma432d agoMedtronic, Inc. — Activa™ and Percept™ Deep Brain Stimulation Therapy System (PMA supplement)Medtronic plc

Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗
›Jun 10, 2025device pma432d agoDavol Inc., Sub. C. R. Bard, Inc. — Avitene Flowable Collagen Hemostat (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LMF. Advisory committee: SU. Decision: APPR

full page →fda device pma ↗
›Jun 10, 2025device pma432d agoOrganox Limited — OrganOx metra System (PMA supplement)

Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗
›Jun 10, 2025device pma432d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication (PMA supplement)Sustained Therapeutics Inc

Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗
›Jun 10, 2025device pma432d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗
›Jun 10, 2025device pma432d agoThe Straumann Company — BIORA EMDOGAIN(R) (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: NQA. Advisory committee: DE. Decision: APPR

full page →fda device pma ↗
›Jun 10, 2025device 510k432d agoDRTECH Corporation — EXTRON 3; EXTRON 5; EXTRON 7 (510k cleared)

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

full page →fda device 510k ↗
›Jun 10, 2025device 510k432d agoFujifilm Corporation — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (510k cleared)Fujifilm Holdings Corp

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

full page →fda device 510k ↗
›Jun 10, 2025device 510k432d agoEndymed Medical, Ltd. — EndyMed PRO MAX (510k cleared)

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

full page →fda device 510k ↗
›Jun 10, 2025device 510k432d agoNihon Kohden Corporation — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (510k cleared)Nihon Kohden Corporation/ADR

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

full page →fda device 510k ↗
›Jun 10, 2025device 510k432d agoRoche Diagnostics — Elecsys Anti-SARS-CoV-2 (510k cleared)

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

full page →fda device 510k ↗
›Jun 10, 2025device 510k432d agoViz. Ai, Inc. — Viz Subdural+, Viz SUBDURAL PLUS (510k cleared)

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

full page →fda device 510k ↗
›Jun 10, 2025device 510k432d agoFomed Industries, Inc. — Dental Barrier and Sleeves (510k cleared)Biomed Industries Inc

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

full page →fda device 510k ↗
›Jun 10, 2025device 510k432d agoVitaltec Corporation — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm (510k cleared)

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

full page →fda device 510k ↗
$NHNKF
$ABBV249.46-0.54%
$MDT91.27+0.76%
$ABBV249.46-0.54%