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calendar

21 catalysts · 13 device 510k · 6 device pma · 2 approval

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 76 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 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: 0 catalysts2026-10-01: 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 catalysts
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  • device 510k13
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therapy area

no tagged catalysts yet

Week of Jun 30, 2025

21
›Jul 1, 2025approval
408d ago
OPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗
›Jul 1, 2025approval408d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: RUBICON RESEARCH. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗
›Jul 1, 2025device pma408d 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 ↗
›Jul 1, 2025device pma408d agoSirtex Medical, Inc. — SIR-Spheres Y-90 resin microspheres (PMA supplement)

Supplement type: Panel Track. Product code: NAW. Advisory committee: RA. Decision: APPR

full page →fda device pma ↗
›Jul 1, 2025device pma408d agoCook Ireland, Ltd. — Zilver Flex(R) 35 Vascular Stent (PMA supplement)

Supplement type: Panel Track. Product code: NIP. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗
›Jul 1, 2025device pma408d agoTransMedics, Inc. — Organ Care System™ (OCS™) Liver (PMA supplement)TransMedics Group, Inc.

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

full page →fda device pma ↗
›Jul 1, 2025device pma408d agoBoston Scientific Corp — AMS 700™ Inflatable Penile Prosthesis (IPP) with and without InhibiZone (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: JCW. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗
›Jul 1, 2025device pma408d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (PMA supplement)

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

full page →fda device pma ↗
›Jul 1, 2025device 510k408d agoAbbott Molecular, Inc. — Alinity m CMV (510k cleared)

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k408d agoHtl-Strefa S.A — droplet® personal lancets (510k cleared)

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k408d agoAccess Vascular, Inc. — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) (510k cleared)

Product code: LJS. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗
›Jul 1, 2025device 510k408d agoFasikl Incorporated — Felix NeuroAI System (510k cleared)

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k408d agoMedacta International S.A. — SnugFit ASA Extension (510k cleared)Stemedica International S.A.

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k408d agoCircle Cardiovascular Imaging, Inc. — StrokeSENS ASPECTS Software Application (510k cleared)

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k408d agoConvatec — Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) (510k cleared)

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k408d agoMedtronic Minimed, Inc. — MiniMed 780G insulin pump (510k cleared)Medtronic USA Inc

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k408d agoArthrex, Inc. — Arthrex iBalance Partial Knee System (510k cleared)

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k408d agoPAJUNK GmbH Medizintechnologie — SonoMSK (510k cleared)

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k408d agoBunkerHill Health — Bunkerhill Abdominal Aortic Quantification (AAQ) (510k cleared)

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k408d agoShenzhen Sophway Technology Co., Ltd. — Endoscopic Camera System (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗
›Jul 1, 2025device 510k408d agoUlrich Medical USA, Inc. — Momentum® Posterior Spinal Fixation System (510k cleared)

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

full page →fda device 510k ↗
$BMY63.85+0.39%
$TMDX69.43-2.72%
$BSX51.55+0.70%
$FRTRY