Emergency Room & Minor Office Procedure Custom Kit

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K844596 ↗

Advisory Committee

Unknown

FDA Decision

SESD Substantially Equivalent — Deferred

• Orthopedic Custom Surgical Kit

  Class I

  FDA 510(k) K844595 Active Cleared 21 Aug 1985

• Catheter Introducer System

  Class II

  FDA 510(k) K843641 Active Cleared 23 Oct 1984

• Miscellaneous General Surgical Custom Kit

  Not classified

  FDA 510(k) K844597 Active Cleared 8 Apr 1985

• Surgical Eye Pack

  Class I

  FDA 510(k) K851906 Active Cleared 21 May 1985

• Neuro Custom Surgical Kit

  Class II

  FDA 510(k) K844594 Active Cleared 13 Jun 1985

• Cardiovascular Custom Surgical Kit

  Class II

  FDA 510(k) K844593 Active Cleared 21 Jun 1985

See all devices from Xanmed Corp. →