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calendar

59 catalysts · 26 recall · 13 device 510k · 11 device pma · 9 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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  • recall26
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therapy area

no tagged catalysts yet

Week of May 26, 2025

9
›
May 28, 2025
device 510k
460d ago
Imperative Care, Inc. — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (510k cleared)

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

full page →fda device 510k ↗
›May 28, 2025device 510k460d agoTermosalud S.L. — Zionic Pro Max (Radiofrequency) (510k cleared)

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

full page →fda device 510k ↗
›May 28, 2025device 510k460d agoBoston Scientific Corporation — OptiMap™ System (510k cleared)BOSTON SCIENTIFIC CORP

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

full page →fda device 510k ↗
›May 28, 2025device 510k460d agoTaiwan Medical Imaging Co., Ltd. — TAIMedImg DeepMets (510k cleared)

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

full page →fda device 510k ↗
›May 28, 2025device 510k460d agoSurGenTec, LLC — OsteoFlo HydroFiber (510k cleared)

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

full page →fda device 510k ↗
›May 28, 2025device 510k460d agoOpcom Medical, Inc. — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) (510k cleared)

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

full page →fda device 510k ↗
›May 28, 2025device 510k460d agoIradimed Corporation — MRidium 3870 MRI Infusion Pump System (3870) (510k cleared)IRADIMED CORP

Product code: FRN. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗
›May 28, 2025device 510k460d agoIschemaview, Inc. — Rapid MLS (510k cleared)

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

full page →fda device 510k ↗
›May 28, 2025device 510k460d agoSmart Soft Healthcare AD — CoLumboX (510k cleared)

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

full page →fda device 510k ↗
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