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calendar

31 catalysts · 20 device 510k · 7 device pma · 4 approval

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2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 1 catalyst2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts
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  • device 510k20
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therapy area

no tagged catalysts yet

Week of Jun 9, 2025

31
›Jun 12, 2025approval
445d ago
KEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗
›Jun 12, 2025approval445d agoVOQUEZNA TRIPLE PAK (AMOXICILLIN) — FDA approvalamoxicillin + clarithromycin + vonoprazan

Sponsor: PHATHOM. Form: CAPSULE, TABLET, TABLET. Route: ORAL

full page →amoxicillin + clarithromycin + vonoprazan →fda approvals ↗
›Jun 12, 2025approval445d agoVOQUEZNA DUAL PAK (AMOXICILLIN) — FDA approvalamoxicillin + vonoprazan fumarate

Sponsor: PHATHOM. Form: CAPSULE, TABLET. Route: ORAL

full page →amoxicillin + vonoprazan fumarate →fda approvals ↗
›Jun 12, 2025approval445d agoDELSTRIGO (DORAVIRINE) — FDA approval(doravirine + lamivudine + tenofovir disoproxil fumarate)

Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

full page →(doravirine + lamivudine + tenofovir disoproxil fumarate) →fda approvals ↗
›Jun 12, 2025device pma445d agoBiotronik, Inc. — Sentus QP Pacing Leads (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: NKE. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗
›Jun 12, 2025device pma445d agoMedtronic, Inc. — Harmony Transcatheter Pulmonary Valve System (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗
›Jun 12, 2025device pma445d agoBiotronik, Inc. — Sentus QP Pacing Leads (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: MRM. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗
›Jun 12, 2025device pma445d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗
›Jun 12, 2025device pma445d agoMedtronic Vascular — Endurant Stent Graft System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗
›Jun 12, 2025device pma445d agoRayner Intraocular Lenses , Ltd. — C-flex lntraocular Lens; C-flex Aspheric lntraocular Lens; 6.0 mm Aspheric lntraocular Lens; RayOne Aspheric; RayOne Sph (PMA supplement)

Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30

full page →fda device pma ↗
›Jun 12, 2025device pma445d agoMedtronic Vascular — Valiant Thoracic Stent Graft with the Captivia Delivery System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗
›Jun 12, 2025device 510k445d agoHt Medical D.B.A. Xenix Medical — RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (510k cleared)

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoNovapproach Spine, LLC — OneLIF™ Interbody Fusion System (510k cleared)

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoBiomérieux — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (510k cleared)Bristol-Myers Squibb Co

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoDavol, Inc. — Bard® Mesh; Bard® Mesh Pre-Shaped (510k cleared)

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoZhengzhou PZ Laser Slim Technology Co., Ltd. — Fractional CO2 Laser Machine (510k cleared)

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoSmith & Nephew, Inc. — TRIGEN Stable Lock Nut & Washer (510k cleared)SMITH & NEPHEW PLC

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoGe Medical Systems Israel — Aurora (510k cleared)

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoEl.En S.P.A. — Deka Bluebeam (510k cleared)

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoId-Fish Technology, Inc. — iDart Lyme IgM ImmunoBlot Kit (510k cleared)Fort Technology Inc

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoBiocomposites, Ltd. — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (510k cleared)

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoBeijing Sano Laser S&T Development Co.,Ltd — Q-Switched Nd:YAG Laser (SHE-LSP101-1) (510k cleared)

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoJeil Medical Corporation — FIX-L PEEK PLIF and T-PLIF System (510k cleared)

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoGm Dos Reis Industria E Comercio — GMReis Fibula Nail System (510k cleared)

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoLg Electronics.Inc — Medical Monitor (32HS710S) (510k cleared)ARROW ELECTRONICS, INC.

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoPearl, Inc. — Second Opinion® CS (510k cleared)

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoMedtronic Sofamor Danek, Inc. — Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (510k cleared)

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoDmax Co., Ltd. — Multi M Series (510k cleared)

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoOlympus Medical Systems Corporation — Disposable Cytology Brush BC-202D/203D Series (510k cleared)

Product code: BTG. Advisory committee: Ear, Nose, Throat. Type: Traditional

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoThermo Fisher Scientific (Oxoid Ltd.) — Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

full page →fda device 510k ↗
›Jun 12, 2025device 510k445d agoFiralis SA — APO-Easy Genotyping kit (510k cleared)Dawn Sea Therapeutics

Product code: SFC. Advisory committee: Immunology. Type: Direct

full page →fda device 510k ↗
$PHAT9.1800+2.68%
$MDT91.23+1.40%
$ARW226.78+1.76%
$PHAT9.1800+2.68%
$TMO447.81+1.31%
$SNN28.97-0.55%
$MRK148.35-0.80%
$FRTT